An observational study in Arthritis, Rheumatoid, sponsored by Pfizer. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Pfizer · Observational
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
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 1,712 is above the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Data will be collected from the Corrona RA Registry. The Corrona registry is a prospective, multicenter, observational disease-based registry launched in 2001.
Exclusion Criteria:
Patients receiving tofacitinib from the Corrona RA Registry from November 2012 onward
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: At 12 months after tofacitinib initiation (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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
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.
| Milestone | Tofacitinib Initiators |
|---|---|
| Started | 1712 |
| Completed | 1712 |
| Not completed | 0 |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators | 30.1 (27.5 to 32.7) |
| Tofacitinib monotherapy initiators | 29.5 (25.8 to 33.6) |
| Tofacitinib combination therapy initiators | 30.4 (27.1 to 34) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators | 31.9 (29 to 35) |
| Tofacitinib monotherapy | 33.1 (28.5 to 37.9) |
| Tofacitinib combination therapy | 31.1 (27.3 to 35.2) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy | 29.9 (27.4 to 32.6) |
| Second line therapy | 35.7 (28.5 to 43.6) |
| Third line therapy | 37.4 (31.4 to 43.9) |
| Fourth line therapy | 26.7 (23.7 to 29.9) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy | 31.9 (28.9 to 35) |
| Second line therapy | 39.4 (30.7 to 48.9) |
| Third line therapy | 39.0 (31.7 to 46.8) |
| Fourth line therapy | 28.8 (25.3 to 32.5) |
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).
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID | 30.0 (26.2 to 34.1) |
| Tofacitinib 11 mg QD | 34.6 (30.5 to 39) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg dose | 34.0 (29.5 to 38.7) |
| Tofacitinib 11 mg dose | 35.4 (30.5 to 40.6) |
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).
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014 | 25.4 (21.1 to 30.4) |
| Initiation period: 2015-2017 | 30.1 (26.3 to 34.1) |
| Initiation period: 2018-2020 | 34.5 (29.7 to 39.6) |
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).
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014 | 29.7 (24.6 to 35.5) |
| Initiation period: 2015-2017 | 32.9 (28.5 to 37.6) |
| Initiation period: 2018-2020 | 32.7 (26.9 to 39.1) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | 8.9 (7.6 to 10.4) |
| Tofacitinib monotherapy initiators: At Month 6 | 8.8 (6.9 to 11.1) |
| Tofacitinib combination therapy initiators: At Month 6 | 9.1 (7.3 to 11.1) |
| Overall tofacitinib initiators: At Month 12 | 10.1 (8.5 to 11.9) |
| Tofacitinib monotherapy initiators: At Month 12 | 9.6 (7.3 to 12.4) |
| Tofacitinib combination therapy initiators: At Month 12 | 10.4 (8.4 to 12.9) |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | -3.47 ± 13.11 |
| Tofacitinib monotherapy initiators: At Month 6 | -2.96 ± 13.37 |
| Tofacitinib combination therapy initiators: At Month 6 | -3.86 ± 12.90 |
| Overall tofacitinib initiators: At Month 12 | -3.46 ± 13.47 |
| Tofacitinib monotherapy initiators: At Month 12 | -3.18 ± 13.76 |
| Tofacitinib combination therapy initiators: At Month 12 | -3.67 ± 13.26 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | -0.04 ± 0.48 |
| Tofacitinib monotherapy initiators: At Month 6 | -0.03 ± 0.49 |
| Tofacitinib combination therapy initiators: At Month 6 | -0.06 ± 0.48 |
| Overall tofacitinib initiators: At Month 12 | -0.06 ± 0.51 |
| Tofacitinib monotherapy initiators: At Month 12 | -0.04 ± 0.50 |
| Tofacitinib combination therapy initiators: At Month 12 | -0.07 ± 0.52 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | -5.72 ± 28.64 |
| Tofacitinib monotherapy initiators: At Month 6 | -4.92 ± 30.18 |
| Tofacitinib combination therapy initiators: At Month 6 | -6.35 ± 27.37 |
| Overall tofacitinib initiators: At Month 12 | -5.69 ± 28.16 |
| Tofacitinib monotherapy initiators: At Month 12 | -4.18 ± 28.09 |
| Tofacitinib combination therapy initiators: At Month 12 | -6.84 ± 28.18 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | -3.84 ± 26.06 |
| Tofacitinib monotherapy initiators: At Month 6 | -2.37 ± 26.40 |
| Tofacitinib combination therapy initiators: At Month 6 | -4.97 ± 25.74 |
| Overall tofacitinib initiators: At Month 12 | -3.36 ± 26.26 |
| Tofacitinib monotherapy initiators: At Month 12 | -2.49 ± 24.85 |
| Tofacitinib combination therapy initiators: At Month 12 | -4.01 ± 27.28 |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | 21.4 (19.5 to 23.5) |
| Tofacitinib monotherapy initiators: At Month 6 | 20.8 (18 to 23.9) |
| Tofacitinib combination therapy initiators: At Month 6 | 21.9 (19.4 to 24.7) |
| Overall tofacitinib initiators: At Month 12 | 22.4 (20.2 to 24.8) |
| Tofacitinib monotherapy initiators: At Month 12 | 21.2 (18 to 24.9) |
| Tofacitinib combination therapy initiators: At Month 12 | 23.3 (20.3 to 26.6) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | 11.4 (9.9 to 13) |
| Tofacitinib monotherapy initiators: At Month 6 | 11.2 (9.1 to 13.7) |
| Tofacitinib combination therapy initiators: At Month 6 | 11.5 (9.6 to 13.8) |
| Overall tofacitinib initiators: At Month 12 | 10.4 (8.8 to 12.2) |
| Tofacitinib monotherapy initiators: At Month 12 | 9.6 (7.4 to 12.4) |
| Tofacitinib combination therapy initiators: At Month 12 | 11.0 (8.9 to 13.6) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | 5.3 (4.3 to 6.5) |
| Tofacitinib monotherapy initiators: At Month 6 | 5.0 (3.6 to 6.8) |
| Tofacitinib combination therapy initiators: At Month 6 | 5.5 (4.2 to 7.2) |
| Overall tofacitinib initiators: At Month 12 | 5.0 (3.9 to 6.4) |
| Tofacitinib monotherapy initiators: At Month 12 | 5.7 (4 to 8) |
| Tofacitinib combination therapy initiators: At Month 12 | 4.4 (3.1 to 6.2) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | 13.7 (12.1 to 15.6) |
| Tofacitinib monotherapy initiators: At Month 6 | 13.7 (11.2 to 16.5) |
| Tofacitinib combination therapy initiators: At Month 6 | 13.8 (11.6 to 16.3) |
| Overall tofacitinib initiators: At Month 12 | 15.5 (13.4 to 17.7) |
| Tofacitinib monotherapy initiators: At Month 12 | 16.4 (13.4 to 20) |
| Tofacitinib combination therapy: At Month 12 | 14.7 (12.2 to 17.7) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib initiators: At Month 6 | 18.7 (16.8 to 20.9) |
| Tofacitinib monotherapy initiators: At Month 6 | 18.3 (15.3 to 21.6) |
| Tofacitinib combination therapy initiators: At Month 6 | 19.1 (16.5 to 22) |
| Overall tofacitinib initiators: At Month 12 | 19.0 (16.7 to 21.5) |
| Tofacitinib monotherapy initiators: At Month 12 | 17.5 (14.2 to 21.4) |
| Tofacitinib combination therapy initiators: At Month 12 | 20.1 (17.1 to 23.6) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | 8.9 (7.6 to 10.5) |
| Second line therapy: At Month 6 | 13.6 (9.6 to 18.9) |
| Third line therapy: At Month 6 | 10.3 (7.4 to 14.3) |
| Fourth line therapy: At Month 6 | 7.4 (6 to 9.2) |
| Overall tofacitinib therapy: At Month 12 | 10.2 (8.6 to 12.1) |
| Second line therapy: At Month 12 | 20.9 (15.2 to 27.9) |
| Third line therapy: At Month 12 | 10.2 (6.8 to 15.1) |
| Fourth line therapy: At Month 12 | 7.9 (6.2 to 10) |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | -3.51 ± 12.95 |
| Second line therapy: At Month 6 | -4.36 ± 12.31 |
| Third line therapy: At Month 6 | -4.96 ± 12.61 |
| Fourth line therapy: At Month 6 | -2.85 ± 13.08 |
| Overall tofacitinib therapy: At Month 12 | -3.54 ± 13.41 |
| Second line therapy: At Month 12 | -4.45 ± 12.71 |
| Third line therapy: At Month 12 | -4.64 ± 12.37 |
| Fourth line therapy: At Month 12 | -3.03 ± 13.73 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | -0.05 ± 0.48 |
| Second line therapy: At Month 6 | -0.05 ± 0.52 |
| Third line therapy: At Month 6 | -0.07 ± 0.48 |
| Fourth line therapy: At Month 6 | -0.04 ± 0.47 |
| Overall tofacitinib therapy: At Month 12 | -0.06 ± 0.51 |
| Second line therapy: At Month 12 | -0.06 ± 0.52 |
| Third line therapy: At Month 12 | -0.07 ± 0.49 |
| Fourth line therapy: At Month 12 | -0.06 ± 0.50 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | -5.71 ± 28.49 |
| Second line therapy: At Month 6 | -8.03 ± 29.83 |
| Third line therapy: At Month 6 | -7.30 ± 28.73 |
| Fourth line therapy: At Month 6 | -4.77 ± 28.02 |
| Overall tofacitinib therapy: At Month 12 | -5.91 ± 28.03 |
| Second line therapy: At Month 12 | -7.09 ± 29.14 |
| Third line therapy: At Month 12 | -8.18 ± 26.49 |
| Fourth line therapy: At Month 12 | -5.17 ± 28.06 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | -4.03 ± 25.98 |
| Second line therapy: At Month 6 | -6.73 ± 26.14 |
| Third line therapy: At Month 6 | -3.70 ± 28.02 |
| Fourth line therapy: At Month 6 | -3.53 ± 25.17 |
| Overall tofacitinib therapy: At Month 12 | -3.63 ± 26.29 |
| Second line therapy: At Month 12 | -5.46 ± 26.16 |
| Third line therapy: At Month 12 | 0.28 ± 24.23 |
| Fourth line therapy: At Month 12 | -4.31 ± 26.69 |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | 21.3 (19.4 to 23.4) |
| Second line therapy: At Month 6 | 25.0 (19.7 to 31.1) |
| Third line therapy: At Month 6 | 24.5 (20.1 to 29.6) |
| Fourth line therapy: At Month 6 | 19.4 (17.1 to 21.9) |
| Overall tofacitinib therapy: At Month 12 | 22.4 (20.2 to 24.9) |
| Second line therapy: At Month 12 | 25.5 (19.3 to 32.8) |
| Third line therapy: At Month 12 | 26.9 (21.5 to 33) |
| Fourth line therapy: At Month 12 | 20.5 (17.9 to 23.5) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | 11.3 (9.9 to 13) |
| Second line therapy: At Month 6 | 12.3 (8.5 to 17.3) |
| Third line therapy: At Month 6 | 14.3 (10.9 to 18.7) |
| Fourth line therapy: At Month 6 | 10.2 (8.5 to 12.2) |
| Overall tofacitinib therapy: At Month 12 | 10.7 (9.1 to 12.6) |
| Second line therapy: At Month 12 | 15.5 (10.7 to 22) |
| Third line therapy: At Month 12 | 12.3 (8.7 to 17.3) |
| Fourth line therapy: At Month 12 | 9.2 (7.4 to 11.4) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | 5.1 (4.2 to 6.3) |
| Second line therapy: At Month 6 | 6.8 (4.2 to 11) |
| Third line therapy: At Month 6 | 7.6 (5.2 to 11.2) |
| Fourth line therapy: At Month 6 | 4.0 (3 to 5.4) |
| Overall tofacitinib therapy: At Month 12 | 5.1 (4 to 6.5) |
| Second line therapy: At Month 12 | 6.2 (3.4 to 11.2) |
| Third line therapy: At Month 12 | 5.7 (3.4 to 9.6) |
| Fourth line therapy: At Month 12 | 4.7 (3.5 to 6.4) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | 13.8 (12.1 to 15.7) |
| Second line therapy: At Month 6 | 18.0 (13.1 to 24.1) |
| Third line therapy: At Month 6 | 18.6 (14.4 to 23.7) |
| Fourth line therapy: At Month 6 | 11.5 (9.6 to 13.6) |
| Overall tofacitinib therapy: At Month 12 | 15.4 (13.3 to 17.7) |
| Second line therapy: At Month 12 | 22.4 (16.3 to 29.9) |
| Third line therapy: At Month 12 | 25.0 (19.3 to 31.7) |
| Fourth line therapy: At Month 12 | 11.4 (9.3 to 13.9) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Overall tofacitinib therapy: At Month 6 | 18.6 (16.6 to 20.8) |
| Second line therapy: At Month 6 | 26.6 (20.3 to 34) |
| Third line therapy: At Month 6 | 22.7 (18 to 28.3) |
| Fourth line therapy: At Month 6 | 16.0 (13.8 to 18.6) |
| Overall tofacitinib therapy: At Month 12 | 19.0 (16.7 to 21.6) |
| Second line therapy: At Month 12 | 34.2 (26 to 43.5) |
| Third line therapy: At Month 12 | 22.8 (17.2 to 29.5) |
| Fourth line therapy: At Month 12 | 15.7 (13.1 to 18.6) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | 9.5 (7.5 to 11.9) |
| Tofacitinib 11 mg QD: At Month 6 | 10.3 (8.2 to 12.9) |
| Tofacitinib 5 mg BID: At Month 12 | 11.2 (8.8 to 14.1) |
| Tofacitinib 11 mg QD: At Month 12 | 10.3 (7.9 to 13.4) |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | -3.97 ± 13.47 |
| Tofacitinib 11 mg QD: At Month 6 | -3.43 ± 12.35 |
| Tofacitinib 5 mg BID: At Month 12 | -4.40 ± 13.73 |
| Tofacitinib 11 mg QD: At Month 12 | -2.77 ± 13.28 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | -0.07 ± 0.49 |
| Tofacitinib 11 mg QD: At Month 6 | -0.03 ± 0.48 |
| Tofacitinib 5 mg BID: At Month 12 | -0.09 ± 0.51 |
| Tofacitinib 11 mg QD: At Month 12 | -0.03 ± 0.52 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | -5.93 ± 29.01 |
| Tofacitinib 11 mg QD: At Month 6 | -6.53 ± 28.58 |
| Tofacitinib 5 mg BID: At Month 12 | -8.02 ± 27.96 |
| Tofacitinib 11 mg QD: At Month 12 | -3.79 ± 28.81 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | -3.89 ± 27.17 |
| Tofacitinib 11 mg: At Month 6 | -3.65 ± 24.79 |
| Tofacitinib 5 mg BID: At Month 12 | -3.52 ± 26.12 |
| Tofacitinib 11 mg: At Month 12 | -2.84 ± 26.98 |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | 23.4 (20.4 to 26.6) |
| Tofacitinib 11 mg QD: At Month 6 | 21.4 (18.4 to 24.7) |
| Tofacitinib 5 mg BID: At Month 12 | 24.2 (20.9 to 27.9) |
| Tofacitinib 11 mg QD: At Month 12 | 22.1 (18.6 to 26.1) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | 13.0 (10.7 to 15.7) |
| Tofacitinib 11 mg QD: At Month 6 | 11.7 (9.4 to 14.4) |
| Tofacitinib 5 mg BID: At Month 12 | 12.3 (9.8 to 15.2) |
| Tofacitinib 11 mg QD: At Month 12 | 9.7 (7.3 to 12.7) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | 5.6 (4.1 to 7.6) |
| Tofacitinib 11 mg QD: At Month 6 | 5.3 (3.8 to 7.3) |
| Tofacitinib 5 mg BID: At Month 12 | 5.3 (3.7 to 7.4) |
| Tofacitinib 11 mg QD: At Month 12 | 4.8 (3.2 to 7.2) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | 15.5 (12.9 to 18.5) |
| Tofacitinib 11 mg QD: At Month 6 | 14.4 (11.8 to 17.5) |
| Tofacitinib 5 mg BID: At Month 12 | 15.6 (12.7 to 19) |
| Tofacitinib 11 mg QD: At Month 12 | 18.2 (14.8 to 22.2) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Tofacitinib 5 mg BID: At Month 6 | 20.7 (17.6 to 24.2) |
| Tofacitinib 11 mg QD: At Month 6 | 19.4 (16.3 to 23) |
| Tofacitinib 5 mg BID: At Month 12 | 21.1 (17.6 to 25.1) |
| Tofacitinib 11 mg QD: At Month 12 | 19.5 (15.9 to 23.8) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | 8.2 (5.9 to 11.2) |
| Initiation period: 2015-2017: At Month 6 | 9.0 (7.1 to 11.4) |
| Initiation period: 2018-2020: At Month 6 | 9.5 (7.2 to 12.4) |
| Initiation period: 2012-2014: At Month 12 | 9.4 (6.7 to 13.1) |
| Initiation period: 2015-2017: At Month 12 | 10.9 (8.6 to 13.8) |
| Initiation period: 2018-2020: At Month 12 | 9.2 (6.5 to 12.9) |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | -3.48 ± 14.72 |
| Initiation period: 2015-2017: At Month 6 | -3.48 ± 12.52 |
| Initiation period: 2018-2020: At Month 6 | -3.44 ± 12.44 |
| Initiation period: 2012-2014: At Month 12 | -4.43 ± 15.02 |
| Initiation period: 2015-2017: At Month 12 | -3.38 ± 13.14 |
| Initiation period: 2018-2020: At Month 12 | -2.59 ± 12.27 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | -0.07 ± 0.47 |
| Initiation period: 2015-2017: At Month 6 | -0.02 ± 0.48 |
| Initiation period: 2018-2020: At Month 6 | -0.05 ± 0.50 |
| Initiation period: 2012-2014: At Month 12 | -0.12 ± 0.49 |
| Initiation period: 2015-2017: At Month 12 | -0.01 ± 0.51 |
| Initiation period: 2018-2020: At Month 12 | -0.07 ± 0.53 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | -5.44 ± 29.31 |
| Initiation period: 2015-2017: At Month 6 | -5.13 ± 29.07 |
| Initiation period: 2018-2020: At Month 6 | -6.80 ± 27.42 |
| Initiation period: 2012-2014: At Month 12 | -8.16 ± 28.39 |
| Initiation period: 2015-2017: At Month 12 | -4.48 ± 28.56 |
| Initiation period: 2018-2020: At Month 12 | -5.27 ± 27.10 |
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.
| Units on a scale | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | -4.84 ± 26.45 |
| Initiation period: 2015-2017: At Month 6 | -3.04 ± 26.73 |
| Initiation period: 2018-2020: At Month 6 | -4.08 ± 24.74 |
| Initiation period: 2012-2014: At Month 12 | -4.98 ± 25.33 |
| Initiation period: 2015-2017: At Month 12 | -3.08 ± 26.98 |
| Initiation period: 2018-2020: At Month 12 | -2.15 ± 25.91 |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | 24.3 (20.5 to 28.6) |
| Initiation period: 2015-2017: At Month 6 | 19.6 (16.8 to 22.7) |
| Initiation period: 2018-2020: At Month 6 | 21.5 (18.1 to 25.3) |
| Initiation period: 2012-2014: At Month 12 | 27.3 (22.9 to 32.3) |
| Initiation period: 2015-2017: At Month 12 | 19.4 (16.4 to 22.9) |
| Initiation period: 2018-2020: At Month 12 | 22.4 (18.2 to 27.3) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | 11.9 (9.2 to 15.3) |
| Initiation period: 2015-2017: At Month 6 | 10.6 (8.6 to 13.2) |
| Initiation period: 2018-2020: At Month 6 | 11.9 (9.4 to 15.1) |
| Initiation period: 2012-2014: At Month 12 | 12.2 (9.1 to 16.1) |
| Initiation period: 2015-2017: At Month 12 | 10.8 (8.5 to 13.6) |
| Initiation period: 2018-2020: At Month 12 | 7.8 (5.3 to 11.3) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | 5.3 (3.5 to 7.8) |
| Initiation period: 2015-2017: At Month 6 | 4.6 (3.3 to 6.4) |
| Initiation period: 2018-2020: At Month 6 | 6.2 (4.4 to 8.6) |
| Initiation period: 2012-2014: At Month 12 | 5.8 (3.8 to 8.8) |
| Initiation period: 2015-2017: At Month 12 | 5.2 (3.7 to 7.4) |
| Initiation period: 2018-2020: At Month 12 | 3.7 (2.1 to 6.5) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | 12.2 (9.4 to 15.7) |
| Initiation period: 2015-2017: At Month 6 | 14.6 (12 to 17.6) |
| Initiation period: 2018-2020: At Month 6 | 14.0 (11.1 to 17.6) |
| Initiation period: 2012-2014: At Month 12 | 12.6 (9.4 to 16.7) |
| Initiation period: 2015-2017: At Month 12 | 16.7 (13.6 to 20.2) |
| Initiation period: 2018-2020: At Month 12 | 16.5 (12.7 to 21.3) |
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.
| Percentage of participants | Tofacitinib Initiators |
|---|---|
| Initiation period: 2012-2014: At Month 6 | 15.8 (12.5 to 20) |
| Initiation period: 2015-2017: At Month 6 | 19.7 (16.6 to 23.1) |
| Initiation period: 2018-2020: At Month 6 | 20.0 (16.4 to 24.2) |
| Initiation period: 2012-2014: At Month 12 | 16.7 (12.8 to 21.4) |
| Initiation period: 2015-2017: At Month 12 | 20.6 (17.1 to 24.5) |
| Initiation period: 2018-2020: At Month 12 | 18.9 (14.6 to 24) |
Collected over Not applicable as adverse events were not collected during the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tofacitinib Initiators | — | — | — |
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.
| Age, Continuous(Years) | Tofacitinib Initiators |
|---|---|
| Mean | 59.99 ± 12.08 |
| Sex: Female, Male(Participants) | Tofacitinib Initiators |
|---|---|
| Female | 1386 |
| Male | 323 |
| Race/Ethnicity, Customized(Participants) | Tofacitinib Initiators |
|---|---|
| White | 1424 |
| Hispanic | 125 |
| Black | 79 |
| Asian | 25 |
| Other | 21 |
| Number of Participants According to Type of Insurance(Participants) | Tofacitinib Initiators |
|---|---|
| None | 18 |
| Private | 1166 |
| Medicare | 701 |
| Medicaid | 109 |
| Number of Participants According to Their Final Education(Participants) | Tofacitinib Initiators |
|---|---|
| Primary | 50 |
| High School | 667 |
| College/University | 940 |
| Other | 10 |
| Number of Participants According to Their Work Status(Participants) | Tofacitinib Initiators |
|---|---|
| Full Time | 544 |
| Part Time | 124 |
| Disabled | 340 |
| Retired | 522 |
| Other | 140 |
| Number of Participants According to Smoking Status(Participants) | Tofacitinib Initiators |
|---|---|
| Never | 835 |
| Previous | 523 |
| Current | 329 |
| Weight(Pounds) | Tofacitinib Initiators |
|---|---|
| Mean | 183.24 ± 46.62 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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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