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This study is to investigate and describe the treatment patterns and effect of tofacitinib indicators for patients with Rheumatoid Arthritis (RA) assessing real world patient data entered in the Corrona RA Registry on or after November 2012
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Rheumatoid Arthritis (RA) | Patients receiving tofacitinib from the Corrona RA Registry from November 2012 onward |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count and swollen joint count (both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a visual analog scale (VAS) from 0 to 100 millimeter (mm); higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores=lower disease activity. A score of <=10 indicated LDA; between >10 and <=22 indicated moderate disease activity and >22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count (TJC) and swollen joint count ([SJC] both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=2.8 indicated remission. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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Data will be collected from the Corrona RA Registry. The Corrona registry is a prospective, multicenter, observational disease-based registry launched in 2001.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38359941 | Derived | Pappas DA, O'Brien J, Moore PC, Dodge R, Germino R, Masri KR, Bingham CO 3rd, Cappelli LC. Treatment Patterns and Effectiveness of Tofacitinib in Patients Initiating Therapy for Rheumatoid Arthritis: Results From the CorEvitas Rheumatoid Arthritis Registry. J Rheumatol. 2024 May 1;51(5):452-461. doi: 10.3899/jrheum.2023-0752. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants with a diagnosis of rheumatoid arthritis enrolled in Corrona Rheumatoid Arthritis (RA) Registry who initiated tofacitinib (tofa) on or after 06-Nov-2012 and had a 6-month follow-up visit or 12-month follow-up visit on or before 31-Jan-2021 were observed retrospectively in this study. Data was retrieved and analyzed during approximately 10 months of this observational retrospective study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib Initiators | Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had at least 6-month follow-up visit before 31-Jan-2021.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib Initiators | Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic. |
| 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 | Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count and swollen joint count (both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a visual analog scale (VAS) from 0 to 100 millimeter (mm); higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores=lower disease activity. A score of <=10 indicated LDA; between >10 and <=22 indicated moderate disease activity and >22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants |
Not applicable as adverse events were not collected during the study
This study involved data that existed as structured data by the time of study start. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not be met, hence safety data were not collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib Initiators | Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2022 | Nov 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2021 | Nov 15, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy | CDAI=composite index for assessing disease activity (DA) based on summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate DA and score >22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any disease modifying antirheumatic drug [DMARD]) and by each line of therapy, second line: participants with prior use of at least 1 conventional synthetic (cs) DMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics. | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy | CDAI=composite index for assessing DA based on numerical summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate DA and score >22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy, second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics. | At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg twice daily (BID) or 11 mg once daily (QD). | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg BID or 11 mg QD. | At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020). | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020). | At 12 months after tofacitinib initiation (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas:dressing,arising,eating,walking,reaching,gripping,hygiene,and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score=sum of domain scores and divided by number of domains answered. Total scores range from 0 to 3 where 0=least difficulty and 3=extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for overall tofa initiators and participants who initiated tofacitinib as either monotherapy or as combination therapy. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. Components included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and patient's global assessment (PtGA) recorded on 100 mm VAS (scores ranging 0 [no disease activity] to 100 mm [maximum disease activity]), higher scores=more disease activity. DAS28 (ESR) was calculated as 0.56*sqrt (TJC28)+0.28*sqrt (SJC28)+0.70*ln (ESR [mm/hour]+0.014*PtGA [mm]; where, ln=natural logarithm, sqrt=square root of. Total score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of <=3.2 indicated LDA or remission. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy, participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as <=20 mm on 100 mm VAS scale in those participants who had pain >20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=2.8 indicated remission. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy including second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics. | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | mACR20 response: >= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 [no disease activity] to 100 mm [maximum disease activity]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln (ESR [mm/hour] + 0.014*PtGA [mm]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of <=3.2 indicated LDA or remission. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as <=20 mm on 100 mm VAS scale in those participants who had pain >20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=2.8 indicated remission. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose | HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose | Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose | mACR20 response: >= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose | mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose | mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose | DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 [no disease activity] to 100 mm [maximum disease activity]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln (ESR [mm/hour] + 0.014*PtGA [mm]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of <=3.2 indicated LDA or remission. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as <=20 mm on 100 mm VAS scale in those participants who had pain >20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=2.8 indicated remission. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation | HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation | Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation | mACR20 response: >= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation | mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation | mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation | DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 [no disease activity] to 100 mm [maximum disease activity]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln (ESR [mm/hour] + 0.014*PtGA [mm]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of <=3.2 indicated LDA or remission. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as <=20 mm on 100 mm VAS scale in those participants who had pain >20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic. | Count of Participants | Participants |
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| Number of Participants According to Type of Insurance | One participant could have more than one type of insurance. | Count of Participants | Participants |
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| Number of Participants According to Their Final Education | Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic. | Count of Participants | Participants |
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| Number of Participants According to Their Work Status | Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic. | Count of Participants | Participants |
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| Number of Participants According to Smoking Status | Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic. | Count of Participants | Participants |
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| Weight | Here Number Analyzed' signifies participants evaluable for this baseline characteristic. | Mean | Standard Deviation | Pounds |
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| Body Mass Index | Here Number Analyzed' signifies participants evaluable for this baseline characteristic. | Mean | Standard Deviation | Kilograms per meter square (Kg/m^2) |
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| Number of Participants With History of Comorbidities | One participant may have more than one comorbidity. | Here Number Analyzed' signifies participants evaluable for specific categories in this baseline characteristic. | Count of Participants | Participants |
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| At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Primary | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count (TJC) and swollen joint count ([SJC] both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Primary | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy | CDAI=composite index for assessing disease activity (DA) based on summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate DA and score >22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any disease modifying antirheumatic drug [DMARD]) and by each line of therapy, second line: participants with prior use of at least 1 conventional synthetic (cs) DMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Primary | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy | CDAI=composite index for assessing DA based on numerical summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate DA and score >22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy, second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Primary | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg twice daily (BID) or 11 mg once daily (QD). | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Primary | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Primary | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020). | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Primary | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=10 indicated LDA; score between >10 and <=22 indicated moderate disease activity and score >22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020). | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 12 months after tofacitinib initiation (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=2.8 indicated remission. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas:dressing,arising,eating,walking,reaching,gripping,hygiene,and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score=sum of domain scores and divided by number of domains answered. Total scores range from 0 to 3 where 0=least difficulty and 3=extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for overall tofa initiators and participants who initiated tofacitinib as either monotherapy or as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. Components included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and patient's global assessment (PtGA) recorded on 100 mm VAS (scores ranging 0 [no disease activity] to 100 mm [maximum disease activity]), higher scores=more disease activity. DAS28 (ESR) was calculated as 0.56*sqrt (TJC28)+0.28*sqrt (SJC28)+0.70*ln (ESR [mm/hour]+0.014*PtGA [mm]; where, ln=natural logarithm, sqrt=square root of. Total score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of <=3.2 indicated LDA or remission. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy, participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as <=20 mm on 100 mm VAS scale in those participants who had pain >20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=2.8 indicated remission. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy including second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | mACR20 response: >= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 [no disease activity] to 100 mm [maximum disease activity]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln (ESR [mm/hour] + 0.014*PtGA [mm]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of <=3.2 indicated LDA or remission. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as <=20 mm on 100 mm VAS scale in those participants who had pain >20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=2.8 indicated remission. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose | HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose | Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose | mACR20 response: >= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose | mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose | mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose | DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 [no disease activity] to 100 mm [maximum disease activity]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln (ESR [mm/hour] + 0.014*PtGA [mm]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of <=3.2 indicated LDA or remission. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as <=20 mm on 100 mm VAS scale in those participants who had pain >20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of <=2.8 indicated remission. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation | CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation | HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation | Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation | mACR20 response: >= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation | mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation | mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation | DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 [no disease activity] to 100 mm [maximum disease activity]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln (ESR [mm/hour] + 0.014*PtGA [mm]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of <=3.2 indicated LDA or remission. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| Secondary | Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation | Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as <=20 mm on 100 mm VAS scale in those participants who had pain >20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported. | Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Tofacitinib combination therapy |
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| Third line therapy |
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| Fourth line therapy |
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| Third line therapy |
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| Fourth line therapy |
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| Initiation period: 2018-2020 |
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| Initiation period: 2018-2020 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 6 |
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| Overall tofacitinib initiators: At Month 12 |
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| Tofacitinib monotherapy initiators: At Month 12 |
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| Tofacitinib combination therapy initiators: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Third line therapy: At Month 6 |
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| Fourth line therapy: At Month 6 |
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| Overall tofacitinib therapy: At Month 12 |
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| Second line therapy: At Month 12 |
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| Third line therapy: At Month 12 |
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| Fourth line therapy: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg QD: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg QD: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg QD: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg QD: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg QD: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg QD: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg QD: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg QD: At Month 12 |
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| Tofacitinib 5 mg BID: At Month 12 |
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| Tofacitinib 11 mg QD: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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| Initiation period: 2018-2020: At Month 6 |
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| Initiation period: 2012-2014: At Month 12 |
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| Initiation period: 2015-2017: At Month 12 |
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| Initiation period: 2018-2020: At Month 12 |
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