A Study To Investigate And Describe The Treatment Patterns And Effect Of Tofacitinib Indicators For Patients With Rheumatoid Arthritis

Treatment Patterns and 6 and 12-Month Effectiveness of Tofacitinib in the Corrona Rheumatoid Arthritis Registry

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid

• Study Type: Observational
• Enrollment (Actual): 1712

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Data will be collected from the Corrona RA Registry. The Corrona registry is a prospective, multicenter, observational disease-based registry launched in 2001.

Description

Inclusion Criteria:

• Enrolled in the Corrona RA Registry and initiated tofacitinib on or after November 2012
• Initiate tofacitinib (defined as first ever use of tofacitinib) at the Corrona enrollment visit or at a Corrona follow-up visit from November 2012 onward.
• Have CDAI measured at baseline
• Have at least a 6-month follow-up visit and CDAI measured at the 6-month follow-up visit

Exclusion Criteria:

• There are no exclusion criteria for this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with Rheumatoid Arthritis (RA); Patients receiving tofacitinib from the Corrona RA Registry from November 2012 onward

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: A3921379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.