A Comparative Study Between ABP 501 and Humira® in Partic... | NCT05073315

NCT05073315

ID	Type	Description	Link
2021-000542-18	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Continued-use Group (Adalimumab)	Active Comparator	Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.	Drug: Adalimumab
Switching Group (Adalimumab - ABP 501)	Experimental	Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.	Drug: Adalimumab Drug: ABP 501

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab	Drug	Participants will receive subcutaneous (SC) injection of adalimumab	Continued-use Group (Adalimumab) Switching Group (Adalimumab - ABP 501)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	Participants analyzed according to actual treatment received.	Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	Participants analyzed according to treatment received.	Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

Secondary Outcomes

Measure	Description	Time Frame
Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	Time to reach maximum serum concentration.	Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose
Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Total Skin and Beauty Dermatology Center PC		Birmingham	Alabama	35205	United States
Johnson Dermatology Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41954860	Derived	Yamauchi PS, Chow V, Mytych DT, Zhou M, Radziszewski W. Comparative Study Assessing Multiple Switches Between Biosimilar ABP 501 (adalimumab-atto) and Adalimumab Reference Product in Patients with Plaque Psoriasis. Adv Ther. 2026 Jun;43(6):2795-2808. doi: 10.1007/s12325-026-03574-8. Epub 2026 Apr 9.

Label	URL
AmgenTrials clinical trials website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Period 1 (Lead-in Period)	Participants with plaque psoriasis (Ps) received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 [80 mg], Week 2/Day 8 [40 mg], Week 4, Week 6, Week 8, and Week 10 [40 mg]) during the Lead-in Period.
FG001	Period 2 (Switching Group)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 3, 2021	Dec 14, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

FG000425 subjects
FG0010 subjects
FG0020 subjects

Data is reported for the Safety Analysis Set and reflects data collected at baseline for the switching and continued use groups.

Arm/Group Information

ID	Title	Description
BG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
BG001	Period 2 (Continued-use Group)	Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00044.9± 13.27 BG00144.3± 13.91 BG00244.6± 13.59

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00056 BG00163 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00027 BG00136 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0012 BG002

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

Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Participants analyzed according to actual treatment received.

The Pharmacokinetic (PK) Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between Weeks 28 and 30.

Posted

Geometric Mean

Geometric Coefficient of Variation

hr*μg/mL

Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)	Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

Units	Counts
Participants	OG000146 OG001145

Title

Denominators

Categories

Title	Measurements
	OG0001458.03± 156.6 OG0011472.68± 174.9

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						Ratio Geometric Least Square Mean (GMR)	1.0516			2-Sided	90	0.9010	1.2273					Equivalence	The prespecified similarity margin was 0.8 to 1.25.

Primary

Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Participants analyzed according to treatment received.

The PK Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between weeks 28 and 30.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)	Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

Secondary

Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

Time to reach maximum serum concentration.

The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of investigational product (IP) post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization.

Posted

Median

Full Range

Hours

Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)	Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

Secondary

Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)

The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of IP post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization. All participants reported in the overall number of participants analyzed contributed data to this analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose at Week 12, Week 16, Week 20, and Week 28

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)	Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

Secondary

PASI Percent Improvement From Baseline (Day 1) to Week 30

The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).

Based on the per-protocol (PP) efficacy analysis set as observed, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

Posted

Mean

95% Confidence Interval

Percentage Change

Baseline (Day 1) and Week 30

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)

Secondary

Number of Participants Achieving PASI 75 Response at Week 30

A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

Based on the PP efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 30

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)

Secondary

Number of Participants Achieving PASI 90 Response at Week 30

A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 30

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)

Secondary

Number of Participants Achieving PASI 100 Response at Week 30

A PASI 100 response is a 100% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

Posted

Count of Participants

Participants

Baseline (Day 1) and Week 30

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)

Secondary

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs.

A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

Population from the Safety Analysis Set (SAS). Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.

Posted

Count of Participants

Participants

Baseline up to Week 32

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001

Secondary

Number of Participants Experiencing Events of Interest (EOI)

An EOI is defined as a noteworthy event for a particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals.

Population from the SAS. Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.

Posted

Count of Participants

Participants

Baseline up to Week 32

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)	Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

Secondary

Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization

Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits.

Posted

Count of Participants

Participants

Week 16, Week 20, Week 28, Week 30, and Week 32

ID	Title	Description
OG000	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).
OG001	Period 2 (Continued-use Group)	Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.

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	Period 1 (Lead-in Period)	Participants with Ps received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 [80 mg], Week 2/Day 8 [40 mg], Week 4, Week 6, Week 8, and Week 10 [40 mg]) during the Lead-in Period.	1	425	5	425	38	425
EG001	Period 2 (Continued-use Group)	Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.	0	194	4	194	28	194
EG002	Period 2 (Switching Group)	Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 [40 mg]), adalimumab Q2W (Week 16 and Week 18 [40 mg]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 [40 mg]).	0	186	3	186	26	186

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected425 at risk EG0010 affected194 at risk EG0020 affected186 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected425 at risk EG0010 affected194 at risk EG0021 affected186 at risk
Colitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected425 at risk EG0011 affected194 at risk EG0020 affected186 at risk
Death	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected425 at risk EG0010 affected194 at risk EG0020 affected186 at risk
Diverticulitis intestinal perforated	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected425 at risk EG0011 affected194 at risk EG0020 affected186 at risk
Tuberculosis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 affected425 at risk EG0011 affected194 at risk EG0020 affected186 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected425 at risk EG0010 affected194 at risk EG0021 affected186 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected425 at risk EG0010 affected194 at risk EG0020 affected186 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 affected425 at risk EG0010 affected194 at risk EG0020 affected186 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 affected425 at risk EG0010 affected194 at risk EG0020 affected186 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected425 at risk EG0010 affected194 at risk EG0020 affected186 at risk
Facial paralysis	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected425 at risk EG0010 affected194 at risk EG0020 affected186 at risk
Trigeminal nerve disorder	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 affected425 at risk EG0010 affected194 at risk EG0020 affected186 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 25.1	Systematic Assessment	EG0000 affected425 at risk EG0011 affected194 at risk EG0020 affected186 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 affected425 at risk EG0010 affected194 at risk EG0021 affected186 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00014 affected425 at risk EG0017 affected194 at risk EG00213 affected186 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG00012 affected425 at risk EG00111 affected194 at risk EG00213 affected186 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG00016 affected425 at risk EG00113 affected194 at risk EG0024 affected186 at risk

First MCP Posted Date

ID	Term
D000068879	Adalimumab
C000630676	ABP 501

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

Units	Counts
Participants	OG000162 OG001160

Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.