A Study to Evaluate Efficacy and Safety of Upadacitinib i... | NCT04169373 | Trialant
NCT04169373
Sponsor
AbbVie
Status
Completed
Last Update Posted
Feb 24, 2026Actual
Enrollment
734Actual
Phase
Phase 3
Conditions
Spondyloarthritis
Interventions
Upadacitinib
Placebo
Countries
United States
Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
China
Czechia
France
Germany
Hungary
Israel
Japan
Mexico
New Zealand
Poland
Russia
Slovakia
South Korea
Spain
Taiwan
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04169373
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M19-944
Secondary IDs
ID
Type
Description
Link
2022-501018-78-00
Other Identifier
EU CT
Brief Title
A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
Official Title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period
Acronym
SELECT-AXIS 2
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Feb 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 26, 2019Actual
Primary Completion Date
Sep 2, 2021Actual
Completion Date
Feb 28, 2025Actual
First Submitted Date
Nov 18, 2019
First Submission Date that Met QC Criteria
Nov 18, 2019
First Posted Date
Nov 19, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Aug 23, 2022
Results First Submitted that Met QC Criteria
Aug 23, 2022
Results First Posted Date
Sep 21, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 6, 2026
Last Update Posted Date
Feb 24, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently.
The main objectives of this protocol are:
To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2).
To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2).
To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2).
To evaluate the maintenance of disease control after withdrawal of upadacitinib.
Detailed Description
Study 1 (bDMARD-IR AS) is comprised of a 14-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 90-week open-label, long-term extension period (the Open-Label Extension Period); and a 30-day Follow-Up Visit (F/U Visit).
Study 2 (nr-axSpA) is comprised of a 52-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 52-week open-label, long-term extension period (the Open-Label Extension Period); and a 30-day F/U Visit.
In the Double-Blind Period for both studies, participants are randomized in a 1:1 ratio to receive either upadacitinib or placebo once daily (QD).
Participants in the placebo group switch to upadacitinib 15 mg QD at Week 14 in the Open-Label Extension Period for Study 1 (bDMARD-IR AS) and Week 52 in the Open-Label Extension Period for Study 2 (nr-axSpA).
Participants in remission at Week 104 have the option to enroll in a remission-withdrawal period.
Study M19-944 protocol uses a common screening platform for determining eligibility into Study 1 and Study 2. Each study has its own objectives, hypothesis testing, randomization, data collection, and adequate power for primary and secondary endpoints. Analysis and reporting are conducted separately and independently for each study.
Conditions Module
Conditions
Spondyloarthritis
Keywords
Upadacitinib
Axial Spondyloarthritis (axSpA)
Spondyloarthritis
Ankylosing Spondylitis (AS)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
734Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Study 1: Upadacitinib 15 mg
Experimental
Participants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Drug: Upadacitinib
Study 1: Placebo
Placebo Comparator
Participants receive matching placebo for 14 weeks and then switch to receive 15 mg upadacitinib orally once a day for 90 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Drug: Upadacitinib
Drug: Placebo
Study 2: Upadacitinib 15 mg
Experimental
Participants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Drug: Upadacitinib
Study 2: Placebo
Placebo Comparator
Participants receive matching placebo for 52 weeks and then switch to receive 15 mg upadacitinib orally once a day for 52 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).
Drug: Upadacitinib
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Upadacitinib
Drug
Upadacitinib tablet administered orally
Study 1: Placebo
Study 1: Upadacitinib 15 mg
Study 2: Placebo
Study 2: Upadacitinib 15 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Baseline and Week 14
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Baseline and Week 14
Secondary Outcomes
Measure
Description
Time Frame
Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Study 1:
Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS,
Must not have total spinal ankylosis
Must have been previously exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis factor [TNF] inhibitor or 1 interleukin [IL]-17 inhibitor [IL-17i]), and must have discontinued the bDMARD therapy due to either lack of efficacy (after at least 12 weeks of treatment with a bDMARD at an adequate dose) or intolerance (irrespective of treatment duration). Prior exposure to two bDMARDs was allowed for no more than 30% of patients; among patients with prior exposure to two bDMARDs, a lack of efficacy to one bDMARD and intolerance to another was permitted, but a patient could not have a lack of efficacy to two bDMARDs
Study 2:
Must have a clinical diagnosis of nr-axSpA fulfilling the 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS
Must have objective signs of active inflammation consistent with axSpA on magnetic resonance imaging (MRI) of sacroiliac (SI) joints or based on high sensitivity C-reactive protein (hsCRP) > the upper limit of normal (ULN).
Prior treatment with at most one bDMARD (either TNF inhibitor or IL-17i) is allowed for at least 20% but no more than 35% of enrolled patients who had to discontinue the prior bDMARD due to either lack of efficacy (after ≥ 12 weeks at an adequate dose) or intolerance (regardless of treatment duration).
Must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits.
Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.
Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
Exclusion Criteria:
Must not have been exposed to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib [Rinvoq®], tofacitinib [Xeljanz®], baricitinib [Olumiant®], filgotinib, ruxolitinib [Jakafi®], abrocitinib [PF-04965842], and peficitinib [Smyraf®]).
Prior bDMARD therapy must be washed out.
Participant must not have a history of an allergic reaction or significant sensitivity to constituents of the study drug.
Baraliakos X, Bessette L, de Vlam K, Taylor PC, Biljan A, Urbanik J, Gao T, Jasion VS, Kato K, Lippe R, Magrey M. Impact of Upadacitinib on Reducing Pain in Patients Across the Axial Spondyloarthritis Spectrum: A Post Hoc Analysis of the Phase 2/3 SELECT-AXIS Studies. Rheumatol Ther. 2026 Jun;13(3):611-628. doi: 10.1007/s40744-026-00834-5. Epub 2026 Mar 13.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
In each study participants were randomized equally to one of two treatment groups. In Study 1 randomization was stratified by high-sensitivity C-reactive protein (hsCRP) at Screening, class of the prior bDMARD use, and geographic region. In Study 2 randomization was stratified by magnetic resonance imaging (MRI) and Screening hsCRP status, and exposure to bDMARDs. For both studies Japan and China each had a separate randomization schedule stratified by Screening hsCRP and MRI (Study 2 only).
Recruitment Details
This master protocol consists of 2 independent studies with a common screening platform for adults with active axial spondyloarthritis (axSpA). Study 1 enrolled adults with ankylosing spondylitis (AS) who had an inadequate response (IR) to biologic disease-modifying antirheumatic drug (bDMARD) therapy. Study 2 enrolled adults with non-radiographic axSpA (nr-axSpA). Each study includes a double-blind treatment period and an ongoing open-label extension period. RW period entry was optional.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DB Study 1: Placebo
Double Blind (DB) Period:
Participants with bDMARD-inadequate response ankylosing spondylitis (bDMARD-IR AS) received placebo tablets orally once a day (QD) for 14 weeks.
Placebo for upadacitinib tablet administered orally
Study 1: Placebo
Study 2: Placebo
Baseline and Week 14
Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14
In the SPARCC MRI assessment of the spine, the entire spine was evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions.
Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice.
The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Baseline and Week 14
Study 1: Percentage of Participants With an ASAS20 Response at Week 14
ASAS20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain:
Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Baseline and Week 14
Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.
Week 14
Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.
Baseline and Week 14
Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.
Baseline and Week 14
Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.
Week 14
Study 1: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Baseline and Week 14
Study 1: Percentage of Participants With ASAS Partial Remission at Week 14
ASAS partial remission (PR) is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Week 14
Study 1: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 14
The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0).
Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.
Baseline and Week 14
Study 1: Change From Baseline in ASAS Health Index at Week 14
The ASAS health index (HI) measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 1: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
The BASMI is a composite score based on 5 direct measurements of spinal mobility:
cervical rotation (measured in degrees),
tragus to wall distance (in centimeters [cm])
lumbar side flexion (in cm),
lumbar flexion (modified Schober's) (in cm) and
intermalleolar distance (in cm).
Each measurement is converted to a linear score between 0 and 10. The total BASMI(lin) score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI(lin) score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 1: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 1: Change From Baseline in MRI SPARCC Score for Sacroiliac Joints at Week 14
In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.
Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant.
The total maximum (worst) score for all SI joints across 6 slices is 72. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Change From Baseline in ASDAS at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Baseline and Week 14
Study 2: Change From Baseline in MRI SPARCC Score for SI Joints at Week 14
In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.
Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant.
The total maximum (worst) score for all SI joints across 6 slices is 72. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Percentage of Participants With BASDAI 50 Response at Week 14
The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Baseline and Week 14
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.
Week 14
Study 2: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.
Baseline and Week 14
Study 2: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.
Baseline and Week 14
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.
Week 14
Study 2: Percentage of Participants With ASAS Partial Remission at Week 14
ASAS partial remission (PR) is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Week 14
Study 2: Change From Baseline in BASFI at Week 14
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Baseline and Week 14
Study 2: Change From Baseline in ASQoL at Week 14
The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0).
Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.
Baseline and Week 14
Study 2: Change From Baseline in ASAS Health Index at Week 14
The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Percentage of Participants Achieving an ASAS20 Response at Week 14
ASAS20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain:
Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Baseline and Week 14
Study 2: Change From Baseline in BASMI(Lin) at Week 14
The BASMI is a composite score based on 5 direct measurements of spinal mobility:
cervical rotation (measured in degrees),
tragus to wall distance (in centimeters [cm])
lumbar side flexion (in cm),
lumbar flexion (modified Schober's) (in cm) and
intermalleolar distance (in cm).
Each measurement is converted to a linear score between 0 and 10. The total BASMI(lin) score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI(lin) score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Change From Baseline in MASES at Week 14
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 52
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Baseline and Week 52
Study 2: Change From Baseline in MRI SPARCC Score for the Spine at Week 14
In the SPARCC MRI assessment of the spine, the entire spine is evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions.
Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice.
The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.
Baseline and Week 14
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52
Participants who did not achieve an ASAS20 response at any 2 consecutive scheduled visits from Week 24 through Week 52 were to be rescued with standard of care treatment as described in the protocol.
Week 24, Week 32, Week 40, and Week 52
Study 2: Percentage of Participants With ASDAS Major Improvement at Week 52
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). Major Improvement is defined as a change from Baseline of ≤ -2.0.
Baseline and Week 52
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 52
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.
Week 52
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 52
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 214159
Odesa
65025
Ukraine
Multifield Medical Centre of ONMU /ID# 214149
Odesa
65026
Ukraine
PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 214151
Poltava
36011
Ukraine
Ternopil University Hospital /ID# 214705
Ternopil
46002
Ukraine
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 214147
Vinnytsia
21028
Ukraine
Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 214148
Vinnytsia
21029
Ukraine
Minerva Health Centre /ID# 216226
Preston
Lancashire
PR1 6SB
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 214865
Norwich
Norfolk
NR4 7UY
United Kingdom
West Suffolk Hospital /ID# 215529
Bury St Edmunds
Suffolk
IP33 2QZ
United Kingdom
Doncaster Royal Infirmary /ID# 214971
Armthorpe Road
DN2 5LT
United Kingdom
Derived
Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.
Navarro-Compan V, Van den Bosch F, Sampaio-Barros PD, Ostor AJK, Parikh B, Kato K, Gao T, Stigler J, Ramiro S. Efficacy of upadacitinib in subgroups of patients with axial spondyloarthritis with early versus established disease. RMD Open. 2025 Mar 4;11(1):e005110. doi: 10.1136/rmdopen-2024-005110.
Van den Bosch F, Deodhar A, Poddubnyy D, Maksymowych WP, van der Heijde D, Kim TH, Kishimoto M, Baraliakos X, Bu X, Lagunes-Galindo I, Song IH, Wung P, Kato K, Shmagel A. Upadacitinib in active non-radiographic axial spondyloarthritis: 2-year data from the phase 3 SELECT-AXIS 2 study. Arthritis Res Ther. 2025 Feb 4;27(1):23. doi: 10.1186/s13075-024-03441-3.
Baraliakos X, van der Heijde D, Sieper J, Inman RD, Kameda H, Maksymowych WP, Lagunes-Galindo I, Bu X, Wung P, Kato K, Shmagel A, Deodhar A. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis refractory to biologic therapy: 2-year clinical and radiographic results from the open-label extension of the SELECT-AXIS 2 study. Arthritis Res Ther. 2024 Nov 12;26(1):197. doi: 10.1186/s13075-024-03412-8.
Burmester GR, Stigler J, Rubbert-Roth A, Tanaka Y, Azevedo VF, Coombs D, Lagunes I, Lippe R, Wung P, Gensler LS. Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials. Rheumatol Ther. 2024 Jun;11(3):737-753. doi: 10.1007/s40744-024-00671-4. Epub 2024 Apr 29.
Rubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.
Kiltz U, Kishimoto M, Walsh JA, Sampaio-Barros P, Mittal M, Saffore CD, Wung P, Ganz F, Biljan A, Poddubnyy D. Effect of Upadacitinib on Quality of Life and Work Productivity in Active Non-radiographic Axial Spondyloarthritis: Results From Randomized Phase 3 Trial SELECT-AXIS 2. Rheumatol Ther. 2023 Aug;10(4):887-899. doi: 10.1007/s40744-023-00550-4. Epub 2023 May 16.
Navarro-Compan V, Baraliakos X, Magrey M, Ostor A, Saffore CD, Mittal M, Song IH, Ganz F, Stigler J, Deodhar A. Effect of Upadacitinib on Disease Activity, Pain, Fatigue, Function, Health-Related Quality of Life and Work Productivity for Biologic Refractory Ankylosing Spondylitis. Rheumatol Ther. 2023 Jun;10(3):679-691. doi: 10.1007/s40744-023-00536-2. Epub 2023 Feb 23.
Deodhar A, Van den Bosch F, Poddubnyy D, Maksymowych WP, van der Heijde D, Kim TH, Kishimoto M, Blanco R, Duan Y, Li Y, Pangan AL, Wung P, Song IH. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022 Jul 30;400(10349):369-379. doi: 10.1016/S0140-6736(22)01212-0.
van der Heijde D, Baraliakos X, Sieper J, Deodhar A, Inman RD, Kameda H, Zeng X, Sui Y, Bu X, Pangan AL, Wung P, Song IH. Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomised, placebo-controlled phase 3 trial. Ann Rheum Dis. 2022 Nov;81(11):1515-1523. doi: 10.1136/ard-2022-222608. Epub 2022 Jul 4.
Double Blind (DB) Period:
Participants with bDMARD-IR AS received 15 mg upadacitinib orally QD for 14 weeks.
FG002
DB Study 2: Placebo
Double Blind (DB) Period:
Participants with nr-axSpA received placebo orally QD for 52 weeks.
FG003
DB Study 2: Upadacitinib 15 mg
Double Blind (DB) Period:
Participants with nr-axSpA received 15 mg upadacitinib orally QD for 52 weeks.
FG004
OL Study 1: Upadacitinib 15 mg
Open Label (OL) Period:
At week 14 participants with bDMARD-IR AS complete the DB period continued onto receive 15 mg upadacitinib QD up to week 104.
FG005
OL Study 2: Upadacitinib 15 mg
Open Label (OL) Period:
At week 52 participants with nr-axSpA who complete the DB period continued onto receive 15 mg upadacitinib QD up to week 104.
FG006
RW Study 1: Off Upadacitinib - No Flare
Remission Withdrawal (RW) Period:
At week 104 participants with bDMARD-IR AS who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment up to week 152 with No Flare with no further treatment.
FG007
RW Study 2: Off Upadacitinib - No Flare
Remission Withdrawal (RW) Period:
At week 104 participants with nr-axSpA who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment up to week 152 with No Flare with no further treatment.
FG008
RW Study 1: Upadacitinib 15 mg - No Flare
Remission Withdrawal (RW) Period:
At week 104 participants with bDMARD-IR AS who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment up to week 152 with No Flare and continued onto receive 15mg upadacitinib QD up to Week 235.
FG009
RW Study 2: Upadacitinib 15 mg - No Flare
Remission Withdrawal (RW) Period:
At week 104 participants with nr-AxSpA who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment up to week 152 with No Flare and continued onto receive 15mg upadacitinib QD up to Week 235.
FG010
RW Study 1: Upadacitinib 15 mg - Flare
Remission Withdrawal (RW) Period:
At week 104 participants with bDMARD-IR AS who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment with Flare by week 152 then received 15mg QD upadacitinib up to Week 235.
FG011
RW Study 2: Upadacitinib 15 mg - Flare
Remission Withdrawal (RW) Period:
At week 104 participants with nr-AxSpA AS who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment with Flare by week 152 then received 15mg upadacitinib QD up to Week 235.
FG012
RW Study 1: Upadacitinib 15 mg - Extension
Remission Withdrawal (RW) Period:
At week 104 participants with bDMARD-IR AS who completed the OL period and did not achieve withdrawal criterion and continued onto receive 15mg upadacitinib QD up to Week 235.
FG013
RW Study 2: Upadacitinib 15 mg - Extension
Remission Withdrawal (RW) Period:
At week 104 participants with nr-AxSpA who completed the OL period and did not achieve withdrawal criterion and continued onto receive 15mg upadacitinib QD up to Week 235.
FG000209 subjects
FG001211 subjects
FG002158 subjects
FG003156 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Received Study Drug
Study drug refers to either upadacitinib or placebo
FG000209 subjects
FG001211 subjects
FG002157 subjects
FG003156 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
Completed Week 14 (Study 1) or Week 52 (Study 2)
FG000204 subjects
FG001206 subjects
FG002138 subjects
FG003133 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0005 subjects
FG0015 subjects
FG00220 subjects
FG00323 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG00212 subjects
FG0038 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
COVID-19 LOGISTICAL RESTRICTIONS
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0013 subjects
FG0027 subjects
FG00310 subjects
FG004
Open Label (OL): Week 14 or 52 - 104
Type
Comment
Milestone Data
STARTED
Includes participants that completed the Double Blind (DB) Treatment Period and entered the Open Label (OL) Treatment Period.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004410 subjects
FG005271 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Remission Withdrawal(RW): Week 104 - 235
Type
Comment
Milestone Data
STARTED
Includes participants who completed the Open Label (OL) Treatment Period and chose to enter the Remission Withdrawal (RW) Treatment Period.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00618 subjects
FG00723 subjects
FG0083 subjects
FG0095 subjects
FG01093 subjects
FG01152 subjects
FG01266 subjects
FG01361 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The full analysis set (FAS) includes all randomized participants who received at least one dose of study drug (upadacitinib or placebo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks. At Week 14 participants switched to receive 15 mg upadacitinib once daily in the open-label extension period.
BG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks and continued to receive 15 mg upadacitinib once daily from Week 14 in the open-label extension period.
BG002
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 52 weeks.
BG003
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000209
BG001211
BG002157
BG003156
BG004733
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Results are reported separately for Study 1 and Study 2
Mean
Standard Deviation
years
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG0020
ParticipantsBG003
Age, Customized
Results are reported separately for Study 1 and Study 2
Count of Participants
Participants
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Sex: Female, Male
Results are reported separately for Study 1 and Study 2
Count of Participants
Participants
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Ethnicity (NIH/OMB)
Results are reported separately for Study 1 and Study 2
Count of Participants
Participants
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Race (NIH/OMB)
Results are reported separately for Study 1 and Study 2
Count of Participants
Participants
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Region
Asia includes China, Taiwan, South Korea, and Japan.
Other includes Australia, Israel, and New Zealand.
Results are reported separately for Study 1 and Study 2
Count of Participants
Participants
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Time Since AS / nr-axSpA Diagnosis
Results are reported separately for Study 1 and Study 2
Mean
Standard Deviation
years
Title
Denominators
Categories
Study 1 - Duration since AS diagnosis
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Duration of AS / nr-axSpA Symptoms
Participants with available data; Results are reported separately for Study 1 and Study 2.
Mean
Standard Deviation
years
Title
Denominators
Categories
Study 1 -Duration of AS symptoms
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Study 1: Class of Prior bDMARD Use
Class of prior bDMARD use was collected in Study 1 only.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Study 2: Prior bDMARD Use
Prior exposure to bDMARDs (yes or no) was a stratification factor in Study 2 only.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
High-sensitivity C-reactive Protein (hsCRP) Level at Screening
The Screening level of hsCRP was a randomization stratification factor. The hsCRP upper limit of normal (ULN) = 2.87 mg/L.
Results are reported separately for Study 1 and Study 2
Count of Participants
Participants
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Spondyloarthritis Research Consortium of Canada (SPARCC) MRI Spine Score
For the SPARCC MRI assessment of the spine, 6 discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all 3 dimensions. Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema. The maximum (worst) overall score for all 6 DVUs is 108.
Participants with available data; Results are reported separately for Study 1 and Study 2.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001
SPARCC MRI Sacroiliac Joint Score
In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.
Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema, and depth.
The total maximum (worst) score for all SI joints across 6 slices is 72.
Participants with available data; Results are reported separately for Study 1 and Study 2.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
Study 1
ParticipantsBG000202
ParticipantsBG001
Study 2: Magnetic Resonance Imaging (MRI) Inflammation Status
MRI-positive is defined as active sacroiliitis according to the Assessment of SpondyloArthritis international Society/Outcome Measures in Rheumatology Clinical Trials (ASAS/OMERACT) definition.
MRI inflammation status was only collected in Study 2.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Study 2: MRI Inflammation and hsCRP Status
MRI-positive is defined as active sacroiliitis according to the ASAS/OMERACT definition; The hsCRP upper limit of normal (ULN) = 2.87 mg/L. Randomization of treatment assignment in Study 2 was stratified by positivity for MRI inflammation in the sacroiliac joints and screening hsCRP status (MRI-positive and hsCRP-positive, MRI-positive and hsCRP-negative, and MRI-negative and hsCRP-positive).
MRI inflammation status was only collected in Study 2.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG001
Patient's Global Assessment of Disease Activity (PtGA)
Assessed by the participant using a numeric rating scale (NRS) ranging from 0 (No activity) to 10 (Severe activity).
Results are reported separately for Study 1 and Study 2.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Patient's Assessment of Total Back Pain
Total back pain was assessed by the participant on a NRS from 0 (no pain) to 10 (most severe pain).
Results are reported separately for Study 1 and Study 2.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
ParticipantsBG002
Bath Ankylosing Spondylitis Functional Index
The Bath Ankylosing Spondylitis Functional Index (BASFI) is used to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, each scored on a NRS ranging from 0 (easy to perform activity) to 10 (impossible to perform activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations.
Results are reported separately for Study 1 and Study 2.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001
Inflammation
Inflammation was measured by the mean of the two morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each assessed on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Results are reported separately for Study 1 and Study 2.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
Study 1
ParticipantsBG000209
ParticipantsBG001211
Participants
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation (MI).
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000209
OG001211
Title
Denominators
Categories
Title
Measurements
OG00018.2(13.0 to 23.4)
OG00144.5(37.8 to 51.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (> ULN vs ≤ ULN).
<0.0001
Response Rate Difference
26.4
2-Sided
95
17.9
34.9
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Primary
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Secondary
Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement (MMRM) analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Secondary
Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14
In the SPARCC MRI assessment of the spine, the entire spine was evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions.
Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice.
The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.
Full analysis set participants with available change from Baseline data
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Secondary
Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 1: Percentage of Participants With an ASAS20 Response at Week 14
ASAS20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain:
Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Secondary
Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000
Secondary
Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000
Secondary
Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 1: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 1: Percentage of Participants With ASAS Partial Remission at Week 14
ASAS partial remission (PR) is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Secondary
Study 1: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 14
The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0).
Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Secondary
Study 1: Change From Baseline in ASAS Health Index at Week 14
The ASAS health index (HI) measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Secondary
Study 1: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
The BASMI is a composite score based on 5 direct measurements of spinal mobility:
cervical rotation (measured in degrees),
tragus to wall distance (in centimeters [cm])
lumbar side flexion (in cm),
lumbar flexion (modified Schober's) (in cm) and
intermalleolar distance (in cm).
Each measurement is converted to a linear score between 0 and 10. The total BASMI(lin) score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI(lin) score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Full analysis set participants with available change from Baseline data
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Secondary
Study 1: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses. A negative change from Baseline indicates improvement.
Full analysis set participants with Baseline enthesitis and at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 1: Change From Baseline in MRI SPARCC Score for Sacroiliac Joints at Week 14
In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.
Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant.
The total maximum (worst) score for all SI joints across 6 slices is 72. A negative change from Baseline indicates improvement.
Full analysis set participants with available change from Baseline data.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 1: Placebo
Participants with bDMARD-IR AS received placebo tablets orally once a day for 14 weeks.
OG001
Study 1: Upadacitinib 15 mg
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Change From Baseline in ASDAS at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Change From Baseline in MRI SPARCC Score for SI Joints at Week 14
In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema.
Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant.
The total maximum (worst) score for all SI joints across 6 slices is 72. A negative change from Baseline indicates improvement.
Full analysis set participants with available change from Baseline data
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Percentage of Participants With BASDAI 50 Response at Week 14
The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000
Secondary
Study 2: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000
Secondary
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Percentage of Participants With ASAS Partial Remission at Week 14
ASAS partial remission (PR) is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Change From Baseline in BASFI at Week 14
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Change From Baseline in ASQoL at Week 14
The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0).
Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
Secondary
Study 2: Change From Baseline in ASAS Health Index at Week 14
The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Secondary
Study 2: Percentage of Participants Achieving an ASAS20 Response at Week 14
ASAS20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain:
Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Secondary
Study 2: Change From Baseline in BASMI(Lin) at Week 14
The BASMI is a composite score based on 5 direct measurements of spinal mobility:
cervical rotation (measured in degrees),
tragus to wall distance (in centimeters [cm])
lumbar side flexion (in cm),
lumbar flexion (modified Schober's) (in cm) and
intermalleolar distance (in cm).
Each measurement is converted to a linear score between 0 and 10. The total BASMI(lin) score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI(lin) score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Full analysis set participants with available change from Baseline data
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
Secondary
Study 2: Change From Baseline in MASES at Week 14
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses. A negative change from Baseline indicates improvement.
Full analysis set participants with Baseline enthesitis and at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 52
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity);
Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Full analysis set; participants who discontinued study drug prior to Week 52 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline and Week 52
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 52 weeks.
OG001
Secondary
Study 2: Change From Baseline in MRI SPARCC Score for the Spine at Week 14
In the SPARCC MRI assessment of the spine, the entire spine is evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions.
Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice.
The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement.
Full analysis set participants with available change from Baseline data
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline and Week 14
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 14 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Secondary
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52
Participants who did not achieve an ASAS20 response at any 2 consecutive scheduled visits from Week 24 through Week 52 were to be rescued with standard of care treatment as described in the protocol.
The analysis population is the Full Analysis Set, which includes all participants who were randomized and received at least one dose of study drug. Even though rescue was not assessed until after Week 24, the interpretation of the analysis is based on the percentage of participants who were rescued out of those who were randomized and received study drug, similar to the analysis of other binary endpoints.
Posted
Number
95% Confidence Interval
percentage of participants
Week 24, Week 32, Week 40, and Week 52
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 52 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
Units
Counts
Participants
Secondary
Study 2: Percentage of Participants With ASDAS Major Improvement at Week 52
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). Major Improvement is defined as a change from Baseline of ≤ -2.0.
Full analysis set; participants who discontinued study drug prior to Week 52 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Week 52
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 52 weeks.
OG001
Study 2: Upadacitinib 15 mg
Secondary
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 52
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score < 1.3.
Full analysis set; participants who discontinued study drug prior to Week 52 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 52 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
Secondary
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 52
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe])
Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity])
Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours])
High-sensitivity C-reactive protein (hs-CRP) in mg/L.
The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score < 2.1.
Full analysis set; participants who discontinued study drug prior to Week 52 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Study 2: Placebo
Participants with nr-axSpA received placebo tablets orally once a day for 52 weeks.
OG001
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
Time Frame
All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent/enrollment (all are acceptable; whichever study team prefers per protocol/study design) to the end of the study. The median time on follow-up (or mean time participants were followed) was 769.5, 902.5, 837.0, 861.0, 794.0, 1015.0, 0.0, 1183.0, 1026.0, 1059.0, 1092.0, 1081.0, 1226.5, and 1182.0 days for arms:
Description
DB Study 1: Pbo, DB Study 1: Upa 15 mg, OL Study 1: Upa 15 mg, DB Study 2: Pbo, DB Study 2: Upa 15 mg, OL Study 2: Upa 15 mg, RW Study 1: Upa 15 mg - No Flare, RW Study 2: Upa 15 mg - No Flare, RW Study 1: Upa 15 mg - Flare, RW Study 2: Upa 15 mg - Flare, RW Study 1: Off Upa - No Flare, RW Study 2: Off Upa - No Flare, RW Study 1: Upa 15 mg - Extension, and RW Study 2: Upa 15 mg - Extension, respectively.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DB Study 1: Placebo
Double Blind (DB) Period:
Participants with bDMARD-inadequate response ankylosing spondylitis (bDMARD-IR AS) received placebo tablets orally once a day (QD) for 14 weeks.
0
209
1
209
35
209
EG001
DB Study 1: Upadacitinib 15 mg
Double Blind (DB) Period:
Participants with bDMARD-IR AS received 15 mg upadacitinib orally QD for 14 weeks.
0
211
6
211
41
211
EG002
OL Study 1: Upadacitinib 15 mg
Open Label (OL) Period:
At week 14 participants with bDMARD-IR AS complete the DB period continued onto receive 15 mg upadacitinib QD up to week 104.
1
410
44
410
172
410
EG003
DB Study 2: Placebo
Double Blind (DB) Period:
Participants with nr-axSpA received placebo orally QD for 52 weeks.
0
158
6
158
69
158
EG004
DB Study 2: Upadacitinib 15 mg
Double Blind (DB) Period:
Participants with nr-axSpA received 15 mg upadacitinib orally QD for 52 weeks.
0
156
7
156
67
156
EG005
OL Study 2: Upadacitinib 15 mg
Open Label (OL) Period:
At week 52 participants with nr-axSpA who complete the DB period continued onto receive 15 mg upadacitinib QD up to week 104.
0
271
22
271
107
271
EG006
RW Study 1: Upadacitinib 15 mg - No Flare
Remission Withdrawal (RW) Period:
At week 104 participants with bDMARD-IR AS who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment up to week 152 with No Flare and continued onto receive 15mg upadacitinib QD up to Week 235.
0
3
0
3
2
3
EG007
RW Study 2: Upadacitinib 15 mg - No Flare
Remission Withdrawal (RW) Period:
At week 104 participants with nr-AxSpA who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment up to week 152 with No Flare and continued onto receive 15mg upadacitinib QD up to Week 235.
0
5
1
5
4
5
EG008
RW Study 1: Upadacitinib 15 mg - Flare
Remission Withdrawal (RW) Period:
At week 104 participants with bDMARD-IR AS who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment with Flare by week 152 then received 15mg QD upadacitinib up to Week 235.
0
93
2
93
28
93
EG009
RW Study 2: Upadacitinib 15 mg - Flare
Remission Withdrawal (RW) Period:
At week 104 participants with nr-AxSpA AS who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment with Flare by week 152 then received 15mg upadacitinib QD up to Week 235.
0
52
3
52
19
52
EG010
RW Study 1: Off Upadacitinib - No Flare
Remission Withdrawal (RW) Period:
At week 104 participants with bDMARD-IR AS who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment up to week 152 with No Flare with no further treatment.
0
18
0
18
4
18
EG011
RW Study 2: Off Upadacitinib - No Flare
Remission Withdrawal (RW) Period:
At week 104 participants with nr-axSpA who completed the OL period and achieved withdrawal criteria and withdrew upadacitinib treatment up to week 152 with No Flare with no further treatment.
0
23
2
23
6
23
EG012
RW Study 1: Upadacitinib 15 mg - Extension
Remission Withdrawal (RW) Period:
At week 104 participants with bDMARD-IR AS who completed the OL period and did not achieve withdrawal criterion and continued onto receive 15mg upadacitinib QD up to Week 235.
0
66
2
66
20
66
EG013
RW Study 2: Upadacitinib 15 mg - Extension
Remission Withdrawal (RW) Period:
At week 104 participants with nr-AxSpA who completed the OL period and did not achieve withdrawal criterion and continued onto receive 15mg upadacitinib QD up to Week 235.
0
61
2
61
22
61
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
BLOOD LOSS ANAEMIA
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG0030 events0 affected158 at risk
EG0040 events0 affected156 at risk
EG0050 events0 affected271 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected93 at risk
EG0090 events0 affected52 at risk
EG0100 events0 affected18 at risk
EG0110 events0 affected23 at risk
EG0120 events0 affected66 at risk
EG0130 events0 affected61 at risk
ACUTE MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
ATRIOVENTRICULAR BLOCK COMPLETE
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
ATRIOVENTRICULAR BLOCK FIRST DEGREE
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
CORONARY ARTERY THROMBOSIS
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
TACHYCARDIA PAROXYSMAL
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
CATARACT
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
IRIDOCYCLITIS
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0022 events2 affected410 at risk
EG003
OPHTHALMOPLEGIA
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
REFRACTION DISORDER
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
STRABISMUS
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
UVEITIS
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0011 events1 affected211 at risk
EG0022 events2 affected410 at risk
EG003
COLITIS ULCERATIVE
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
PANCREATITIS ACUTE
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
PANCREATITIS CHRONIC
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
VARICES OESOPHAGEAL
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
CHOLANGITIS ACUTE
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0011 events1 affected211 at risk
EG0020 events0 affected410 at risk
EG003
CHOLECYSTITIS
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
HEPATIC CYST
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
LIVER DISORDER
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
METABOLIC DYSFUNCTION-ASSOCIATED LIVER DISEASE
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
COMPLICATED APPENDICITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0022 events2 affected410 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0011 events1 affected211 at risk
EG0022 events2 affected410 at risk
EG003
COVID-19 PNEUMONIA
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0014 events4 affected211 at risk
EG0027 events7 affected410 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
HAEMORRHAGIC FEVER WITH RENAL SYNDROME
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
HERPES SIMPLEX MENINGOMYELITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
HERPES ZOSTER DISSEMINATED
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
LATENT SYPHILIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
PERITONITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
PNEUMONIA VIRAL
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
ANIMAL BITE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
FOOT FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
FRACTURE DISPLACEMENT
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
HIP FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
JOINT DISLOCATION
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
MENISCUS INJURY
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
MULTIPLE INJURIES
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
TENDON RUPTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
TIBIA FRACTURE
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
ANKYLOSING SPONDYLITIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
LUMBAR SPINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
OSTEOPOROTIC FRACTURE
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
SPINAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0022 events2 affected410 at risk
EG003
COLORECTAL ADENOCARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
INVASIVE DUCTAL BREAST CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
LYMPHOPROLIFERATIVE DISORDER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
METASTASES TO LIVER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
PLEOMORPHIC ADENOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
TONSIL CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
UTERINE LEIOMYOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
BASAL GANGLIA HAEMORRHAGE
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
CARPAL TUNNEL SYNDROME
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
CEREBRAL INFARCTION
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
URETEROLITHIASIS
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0022 events2 affected410 at risk
EG003
CERVICAL DYSPLASIA
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
ENDOMETRIOSIS
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
HEAVY MENSTRUAL BLEEDING
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
NASAL POLYPS
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0022 events2 affected410 at risk
EG003
PULMONARY INFARCTION
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0014 events4 affected211 at risk
EG00218 events13 affected410 at risk
EG0033 events2 affected158 at risk
EG0041 events1 affected156 at risk
EG0053 events3 affected271 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected93 at risk
EG0095 events3 affected52 at risk
EG0100 events0 affected18 at risk
EG0110 events0 affected23 at risk
EG0125 events3 affected66 at risk
EG0132 events2 affected61 at risk
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected209 at risk
EG0016 events6 affected211 at risk
EG00212 events10 affected410 at risk
EG003
ARTERIOSCLEROSIS CORONARY ARTERY
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected209 at risk
EG0013 events3 affected211 at risk
EG0028 events7 affected410 at risk
EG003
ILEAL ULCER
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected209 at risk
EG00110 events10 affected211 at risk
EG00281 events78 affected410 at risk
EG003
FUNGAL FOOT INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected209 at risk
EG0015 events5 affected211 at risk
EG00244 events28 affected410 at risk
EG003
POST-ACUTE COVID-19 SYNDROME
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected209 at risk
EG0013 events2 affected211 at risk
EG00235 events23 affected410 at risk
EG003
ANIMAL SCRATCH
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
BONE CONTUSION
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0012 events2 affected211 at risk
EG0022 events2 affected410 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0021 events1 affected410 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected209 at risk
EG0014 events3 affected211 at risk
EG00216 events13 affected410 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0011 events1 affected211 at risk
EG0021 events1 affected410 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00010 events8 affected209 at risk
EG0010 events0 affected211 at risk
EG00220 events15 affected410 at risk
EG003
AXIAL SPONDYLOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0005 events4 affected209 at risk
EG0010 events0 affected211 at risk
EG00213 events11 affected410 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected209 at risk
EG0011 events1 affected211 at risk
EG00212 events12 affected410 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0011 events1 affected211 at risk
EG0023 events2 affected410 at risk
EG003
SPONDYLITIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0022 events2 affected410 at risk
EG003
TENOSYNOVITIS
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected209 at risk
EG0010 events0 affected211 at risk
EG0024 events3 affected410 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected209 at risk
EG0017 events7 affected211 at risk
EG00210 events8 affected410 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected209 at risk
EG0010 events0 affected211 at risk
EG0023 events3 affected410 at risk
EG003
RENAL CYST
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0022 events2 affected410 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0010 events0 affected211 at risk
EG0020 events0 affected410 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected209 at risk
EG0011 events1 affected211 at risk
EG0022 events2 affected410 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected209 at risk
EG0010 events0 affected211 at risk
EG00215 events14 affected410 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG00022.5(16.0 to 29.1)
OG00144.9(37.1 to 52.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.
Binary endpoints in Study 2 were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the main stratification factor of positivity for MRI inflammation in the sacroiliac joints and screening hsCRP status (MRI-positive and hsCRP > ULN vs MRI-positive and hsCRP ≤ ULN vs MRI-negative and hsCRP > ULN).
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP status.
<0.0001
Response Rate Difference
22.2
2-Sided
95
12.1
32.3
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
OG000
OG001
A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.
Odds Ratio (OR)
2.8
2-Sided
95
1.7
4.5
Upadacitinib : Placebo
Other
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000209
OG001211
Title
Denominators
Categories
Title
Measurements
OG000-0.49(-0.62 to -0.37)
OG001-1.52(-1.64 to -1.39)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (> ULN vs ≤ ULN) and Baseline value as covariate.
<0.0001
Least Squares (LS) Mean Difference
-1.02
2-Sided
95
-1.20
-0.85
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000186
OG001181
Title
Denominators
Categories
Title
Measurements
OG000-0.04(-1.14 to 1.06)
OG001-3.95(-5.06 to -2.83)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.
<0.0001
LS Mean Difference
-3.90
2-Sided
95
-5.47
-2.33
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000209
OG001211
Title
Denominators
Categories
Title
Measurements
OG00016.7(11.7 to 21.8)
OG00143.1(36.4 to 49.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (> ULN vs ≤ ULN).
<0.0001
Response Rate Difference
26.4
2-Sided
95
18.0
34.8
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000209
OG001211
Title
Denominators
Categories
Title
Measurements
OG00038.3(31.7 to 44.9)
OG00165.4(59.0 to 71.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (> ULN vs ≤ ULN).
<0.0001
Response Rate Difference
27.1
2-Sided
95
17.9
36.3
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000209
OG001211
Title
Denominators
Categories
Title
Measurements
OG0001.9(0.1 to 3.8)
OG00112.8(8.3 to 17.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (> ULN vs ≤ ULN).
<0.0001
Response Rate Difference
10.9
2-Sided
95
6.0
15.8
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
209
OG001211
Title
Denominators
Categories
Title
Measurements
OG000-1.47(-1.77 to -1.16)
OG001-3.00(-3.30 to -2.70)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (> ULN vs ≤ ULN) and Baseline value as covariate.
<0.0001
LS Mean Difference
-1.53
2-Sided
95
-1.96
-1.11
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
208
OG001211
Title
Denominators
Categories
Title
Measurements
OG000-1.52(-1.84 to -1.20)
OG001-3.21(-3.52 to -2.89)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (> ULN vs ≤ ULN) and Baseline value as covariate.
<0.0001
LS Mean Difference
-1.69
2-Sided
95
-2.14
-1.24
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000209
OG001211
Title
Denominators
Categories
Title
Measurements
OG00010.1(6.0 to 14.2)
OG00144.1(37.4 to 50.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (> ULN vs ≤ ULN).
<0.0001
Response Rate Difference
34.0
2-Sided
95
26.2
41.8
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000209
OG001211
Title
Denominators
Categories
Title
Measurements
OG000-1.09(-1.35 to -0.83)
OG001-2.26(-2.53 to -2.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (> ULN vs ≤ ULN) and Baseline value as covariate.
<0.0001
LS Mean Difference
-1.17
2-Sided
95
-1.55
-0.80
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Participants with bDMARD-IR AS received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000209
OG001211
Title
Denominators
Categories
Title
Measurements
OG0004.3(1.6 to 7.1)
OG00117.5(12.4 to 22.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (> ULN vs ≤ ULN).
<0.0001
Response Rate Difference
13.2
2-Sided
95
7.4
19.0
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Participants
OG000208
OG001210
Title
Denominators
Categories
Title
Measurements
OG000-2.03(-2.62 to -1.44)
OG001-5.10(-5.69 to -4.52)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (> ULN vs ≤ ULN) and Baseline value as covariate.
<0.0001
LS Mean Difference
-3.07
2-Sided
95
-3.90
-2.24
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Participants
OG000208
OG001211
Title
Denominators
Categories
Title
Measurements
OG000-1.07(-1.51 to -0.64)
OG001-2.93(-3.36 to -2.50)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (> ULN vs ≤ ULN) and Baseline value as covariate.
<0.0001
LS Mean Difference
-1.85
2-Sided
95
-2.47
-1.24
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Participants
OG000201
OG001205
Title
Denominators
Categories
Title
Measurements
OG000-0.16(-0.26 to -0.06)
OG001-0.48(-0.58 to -0.38)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.
<0.0001
LS Mean Difference
-0.32
2-Sided
95
-0.46
-0.18
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000162
OG001148
Title
Denominators
Categories
Title
Measurements
OG000-1.1(-1.5 to -0.8)
OG001-2.6(-3.0 to -2.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (> ULN vs ≤ ULN) and Baseline value as covariate.
<0.0001
LS Mean Difference
-1.5
2-Sided
95
-2.0
-0.9
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000186
OG001181
Title
Denominators
Categories
Title
Measurements
OG0001.05(0.22 to 1.89)
OG001-2.26(-3.10 to -1.41)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.
<0.0001
This comparison was not part of the pre-specified multiplicity testing sequence.
LS Mean Difference
-3.31
2-Sided
95
-4.50
-2.12
Treatment difference = Upadacitinib - Placebo
Other
Units
Counts
Participants
OG000156
OG001154
Title
Denominators
Categories
Title
Measurements
OG000-0.71(-0.85 to -0.56)
OG001-1.36(-1.50 to -1.21)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.
<0.0001
LS Mean Difference
-0.65
2-Sided
95
-0.85
-0.45
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000148
OG001140
Title
Denominators
Categories
Title
Measurements
OG0000.57(-0.17 to 1.30)
OG001-2.49(-3.22 to -1.77)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA model including treatment, main stratification factor, treatment and stratification factor interaction and Baseline value as covariate.
<0.0001
LS Mean Difference
-3.06
2-Sided
95
-4.08
-2.04
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG00022.1(15.5 to 28.6)
OG00142.3(34.6 to 50.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.
0.0001
Response Rate Difference
20.1
2-Sided
95
10.1
30.1
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
OG000
OG001
A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.
Odds Ratio (OR)
2.6
2-Sided
95
1.6
4.2
Upadacitinib : Placebo
Other
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG0005.2(1.7 to 8.7)
OG00114.1(8.6 to 19.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.
0.0063
Response Rate Difference
8.8
2-Sided
95
2.5
15.2
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
OG000
OG001
A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.
Odds Ratio (OR)
3.0
2-Sided
95
1.3
7.0
Upadacitinib : Placebo
Other
156
OG001154
Title
Denominators
Categories
Title
Measurements
OG000-2.00(-2.35 to -1.65)
OG001-2.91(-3.27 to -2.56)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.
0.0004
LS Mean Difference
-0.92
2-Sided
95
-1.42
-0.41
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
154
OG001151
Title
Denominators
Categories
Title
Measurements
OG000-1.84(-2.23 to -1.44)
OG001-2.96(-3.36 to -2.56)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.
0.0001
LS Mean Difference
-1.12
2-Sided
95
-1.68
-0.55
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG00018.3(12.2 to 24.4)
OG00142.3(34.6 to 50.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.
<0.0001
Response Rate Difference
23.8
2-Sided
95
14.2
33.4
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
OG000
OG001
A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.
Odds Ratio (OR)
3.2
2-Sided
95
1.9
5.4
Upadacitinib : Placebo
Other
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG0007.6(3.5 to 11.8)
OG00118.6(12.5 to 24.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.
0.0035
Response Rate Difference
10.9
2-Sided
95
3.6
18.3
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
OG000
OG001
A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.
Odds Ratio (OR)
2.7
2-Sided
95
1.3
5.6
Upadacitinib : Placebo
Other
Units
Counts
Participants
OG000156
OG001154
Title
Denominators
Categories
Title
Measurements
OG000-1.47(-1.79 to -1.15)
OG001-2.61(-2.94 to -2.29)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.
<0.0001
LS Mean Difference
-1.14
2-Sided
95
-1.60
-0.68
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
OG000154
OG001151
Title
Denominators
Categories
Title
Measurements
OG000-3.15(-3.87 to -2.43)
OG001-5.38(-6.11 to -4.65)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.
<0.0001
LS Mean Difference
-2.23
2-Sided
95
-3.26
-1.21
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Participants
OG000154
OG001150
Title
Denominators
Categories
Title
Measurements
OG000-1.48(-2.02 to -0.93)
OG001-3.26(-3.81 to -2.70)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.
<0.0001
LS Mean Difference
-1.78
2-Sided
95
-2.56
-1.00
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 14 weeks.
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG00043.8(36.0 to 51.5)
OG00166.7(59.3 to 74.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.
<0.0001
Response Rate Difference
22.8
2-Sided
95
12.2
33.4
Response Rate Difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
OG000
OG001
A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.
Odds Ratio (OR)
2.5
2-Sided
95
1.6
4.0
Upadacitinib : Placebo
Other
OG000148
OG001144
Title
Denominators
Categories
Title
Measurements
OG000-0.19(-0.29 to -0.08)
OG001-0.29(-0.40 to -0.18)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA model including treatment and main stratification factor MRI and hsCRP status as fixed factors and Baseline value as covariate.
0.1781
LS Mean Difference
-0.10
2-Sided
95
-0.25
0.05
Treatment difference = Upadacitinib - Placebo
Superiority
To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.
Units
Counts
Participants
OG000125
OG001124
Title
Denominators
Categories
Title
Measurements
OG000-1.6(-2.0 to -1.2)
OG001-2.3(-2.7 to -1.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed-effect Model Repeated Measurement
MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.
0.0193
LS Mean Difference
-0.7
2-Sided
95
-1.3
-0.1
Treatment difference = Upadacitinib - Placebo
Other
Study 2: Upadacitinib 15 mg
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG00042.7(34.9 to 50.4)
OG00162.8(55.2 to 70.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.
0.0003
Response Rate Difference
20.1
2-Sided
95
9.3
30.9
Response Rate Difference = Upadacitinib - Placebo
Superiority
Units
Counts
Participants
OG000146
OG001136
Title
Denominators
Categories
Title
Measurements
OG0000.34(-0.32 to 1.00)
OG001-0.79(-1.48 to -0.11)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA model including treatment and main stratification factors MRI and hsCRP status as fixed factors and Baseline value as covariate.
0.0206
This comparison was not part of the pre-specified multiplicity testing sequence.
LS Mean Difference
-1.13
2-Sided
95
-2.08
-0.17
Treatment difference = Upadacitinib - Placebo
Other
OG000157
OG001156
Title
Denominators
Categories
Week 24
Title
Measurements
OG00013.4(8.5 to 19.7)
OG0015.1(2.2 to 9.9)
Week 32
Title
Measurements
OG0001.9(0.4 to 5.5)
OG0013.2(1.0 to 7.3)
Week 40
Title
Measurements
OG0000.6(0.0 to 3.5)
OG0010.6(0.0 to 3.5)
Week 52
Title
Measurements
OG0001.3(0.2 to 4.5)
OG0010(0.0 to 2.3)
Participants with nr-axSpA received 15 mg upadacitinib orally once a day for 52 weeks.
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG00020.4(14.1 to 26.7)
OG00137.8(30.2 to 45.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.
0.0004
This comparison was not part of the pre-specified multiplicity testing sequence.
Response Rate Difference
17.6
2-Sided
95
7.9
27.3
Response Rate Difference = Upadacitinib - Placebo
Superiority
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG00010.8(6.0 to 15.7)
OG00132.7(25.3 to 40.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.
<0.0001
This comparison was not part of the pre-specified multiplicity testing sequence.
Response Rate Difference
21.9
2-Sided
95
13.2
30.6
Response Rate Difference = Upadacitinib - Placebo
Superiority
Units
Counts
Participants
OG000157
OG001156
Title
Denominators
Categories
Title
Measurements
OG00032.5(25.2 to 39.9)
OG00155.8(48.0 to 63.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.
<0.0001
This comparison was not part of the pre-specified multiplicity testing sequence.