Arthritis, Rheumatoid
Conditions
Brief summary
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
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Enrolled in the Corrona RA Registry and initiated tofacitinib on or after November 2012 * Initiate tofacitinib (defined as first ever use of tofacitinib) at the Corrona enrollment visit or at a Corrona follow-up visit from November 2012 onward. * Have CDAI measured at baseline * Have at least a 6-month follow-up visit and CDAI measured at the 6-month follow-up visit
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy | At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose | At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation | At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation | At 12 months after tofacitinib initiation (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved Remission at Month 6 and 12: by Line of Therapy | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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. |
| Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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. |
| Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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. |
| Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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. |
| Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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. |
| Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 With Mild Pain at Month 6 and 12: by Line of Therapy | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved Remission at Month 6 and 12: by Tofa Dose | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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. |
| Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose | 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) | 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. |
| Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose | 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) | 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. |
| Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose | 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) | 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. |
| Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose | 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) | 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. |
| Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving mACR50 Response at Month 6 and 12: by Tofa Dose | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving mACR70 Response at Month 6 and 12: by Tofa Dose | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 With Mild Pain at Month 6 and 12: by Tofa Dose | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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. |
| Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation | 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) | 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. |
| Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation | 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) | 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. |
| Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation | 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) | 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. |
| Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation | 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) | 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. |
| Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 With Mild Pain at Month 6 and 12: by Time Periods of Initiation | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation | At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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. |
| Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | 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) | 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. |
| Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | 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) | 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. |
| 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 | 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) | 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. |
| Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | 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) | 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. |
| 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 | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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 Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib Initiators Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study. | 1,712 |
| Total | 1,712 |
Baseline characteristics
| Characteristic | Tofacitinib Initiators |
|---|---|
| Age, Continuous | 59.99 Years STANDARD_DEVIATION 12.08 |
| Body Mass Index | 30.45 Kilograms per meter square (Kg/m^2) STANDARD_DEVIATION 7.38 |
| Number of Participants According to Smoking Status Current | 329 Participants |
| Number of Participants According to Smoking Status Never | 835 Participants |
| Number of Participants According to Smoking Status Previous | 523 Participants |
| Number of Participants According to Their Final Education College/University | 940 Participants |
| Number of Participants According to Their Final Education High School | 667 Participants |
| Number of Participants According to Their Final Education Other | 10 Participants |
| Number of Participants According to Their Final Education Primary | 50 Participants |
| Number of Participants According to Their Work Status Disabled | 340 Participants |
| Number of Participants According to Their Work Status Full Time | 544 Participants |
| Number of Participants According to Their Work Status Other | 140 Participants |
| Number of Participants According to Their Work Status Part Time | 124 Participants |
| Number of Participants According to Their Work Status Retired | 522 Participants |
| Number of Participants According to Type of Insurance Medicaid | 109 Participants |
| Number of Participants According to Type of Insurance Medicare | 701 Participants |
| Number of Participants According to Type of Insurance None | 18 Participants |
| Number of Participants According to Type of Insurance Private | 1166 Participants |
| Number of Participants With History of Comorbidities Cardiovascular disease | 718 Participants |
| Number of Participants With History of Comorbidities Depression | 305 Participants |
| Number of Participants With History of Comorbidities Diabetes | 192 Participants |
| Number of Participants With History of Comorbidities Fibromyalgia | 134 Participants |
| Number of Participants With History of Comorbidities Hypertension | 607 Participants |
| Number of Participants With History of Comorbidities Malignancy | 219 Participants |
| Number of Participants With History of Comorbidities Osteoporosis | 59 Participants |
| Race/Ethnicity, Customized Asian | 25 Participants |
| Race/Ethnicity, Customized Black | 79 Participants |
| Race/Ethnicity, Customized Hispanic | 125 Participants |
| Race/Ethnicity, Customized Other | 21 Participants |
| Race/Ethnicity, Customized White | 1424 Participants |
| Sex: Female, Male Female | 1386 Participants |
| Sex: Female, Male Male | 323 Participants |
| Weight | 183.24 Pounds STANDARD_DEVIATION 46.62 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy
CDAI=composite index for assessing DA based on numerical summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate DA and score \>22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy, second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.
Time frame: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy | Overall tofacitinib therapy | 31.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy | Second line therapy | 39.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy | Third line therapy | 39.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy | Fourth line therapy | 28.8 Percentage of participants |
Primary
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count (TJC) and swollen joint count (\[SJC\] both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Time frame: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Overall tofacitinib initiators | 31.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib monotherapy | 33.1 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib combination therapy | 31.1 Percentage of participants |
Primary
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020).
Time frame: At 12 months after tofacitinib initiation (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation | Initiation period: 2015-2017 | 32.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation | Initiation period: 2018-2020 | 32.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation | Initiation period: 2012-2014 | 29.7 Percentage of participants |
Primary
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg BID or 11 mg QD.
Time frame: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose | Tofacitinib 5 mg dose | 34.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose | Tofacitinib 11 mg dose | 35.4 Percentage of participants |
Primary
Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy
CDAI=composite index for assessing disease activity (DA) based on summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate DA and score \>22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any disease modifying antirheumatic drug \[DMARD\]) and by each line of therapy, second line: participants with prior use of at least 1 conventional synthetic (cs) DMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.
Time frame: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy | Overall tofacitinib therapy | 29.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy | Second line therapy | 35.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy | Third line therapy | 37.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy | Fourth line therapy | 26.7 Percentage of participants |
Primary
Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020).
Time frame: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation | Initiation period: 2012-2014 | 25.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation | Initiation period: 2015-2017 | 30.1 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation | Initiation period: 2018-2020 | 34.5 Percentage of participants |
Primary
Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg twice daily (BID) or 11 mg once daily (QD).
Time frame: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose | Tofacitinib 5 mg BID | 30.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose | Tofacitinib 11 mg QD | 34.6 Percentage of participants |
Primary
Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count and swollen joint count (both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a visual analog scale (VAS) from 0 to 100 millimeter (mm); higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; between \>10 and \<=22 indicated moderate disease activity and \>22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Time frame: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators | 30.1 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators | 29.5 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators | 30.4 Percentage of participants |
Secondary
Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | -4.96 Units on a scale | Standard Deviation 12.61 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | -3.54 Units on a scale | Standard Deviation 13.41 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | -3.51 Units on a scale | Standard Deviation 12.95 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | -4.36 Units on a scale | Standard Deviation 12.31 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | -2.85 Units on a scale | Standard Deviation 13.08 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | -4.45 Units on a scale | Standard Deviation 12.71 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | -4.64 Units on a scale | Standard Deviation 12.37 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | -3.03 Units on a scale | Standard Deviation 13.73 |
Secondary
Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Overall tofacitinib initiators: At Month 6 | -3.47 Units on a scale | Standard Deviation 13.11 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib monotherapy initiators: At Month 6 | -2.96 Units on a scale | Standard Deviation 13.37 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib monotherapy initiators: At Month 12 | -3.18 Units on a scale | Standard Deviation 13.76 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib combination therapy initiators: At Month 12 | -3.67 Units on a scale | Standard Deviation 13.26 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib combination therapy initiators: At Month 6 | -3.86 Units on a scale | Standard Deviation 12.9 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Overall tofacitinib initiators: At Month 12 | -3.46 Units on a scale | Standard Deviation 13.47 |
Secondary
Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 6 | -3.48 Units on a scale | Standard Deviation 12.52 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 6 | -3.44 Units on a scale | Standard Deviation 12.44 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 6 | -3.48 Units on a scale | Standard Deviation 14.72 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 12 | -4.43 Units on a scale | Standard Deviation 15.02 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 12 | -3.38 Units on a scale | Standard Deviation 13.14 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 12 | -2.59 Units on a scale | Standard Deviation 12.27 |
Secondary
Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | -3.97 Units on a scale | Standard Deviation 13.47 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 6 | -3.43 Units on a scale | Standard Deviation 12.35 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | -4.40 Units on a scale | Standard Deviation 13.73 |
| Tofacitinib Initiators | Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 12 | -2.77 Units on a scale | Standard Deviation 13.28 |
Secondary
Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | -0.07 Units on a scale | Standard Deviation 0.48 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | -0.04 Units on a scale | Standard Deviation 0.47 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | -0.06 Units on a scale | Standard Deviation 0.52 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | -0.07 Units on a scale | Standard Deviation 0.49 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | -0.06 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | -0.05 Units on a scale | Standard Deviation 0.48 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | -0.05 Units on a scale | Standard Deviation 0.52 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | -0.06 Units on a scale | Standard Deviation 0.51 |
Secondary
Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 6 | -0.02 Units on a scale | Standard Deviation 0.48 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 6 | -0.05 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 12 | -0.12 Units on a scale | Standard Deviation 0.49 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 6 | -0.07 Units on a scale | Standard Deviation 0.47 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 12 | -0.01 Units on a scale | Standard Deviation 0.51 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 12 | -0.07 Units on a scale | Standard Deviation 0.53 |
Secondary
Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 12 | -0.03 Units on a scale | Standard Deviation 0.52 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | -0.07 Units on a scale | Standard Deviation 0.49 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 6 | -0.03 Units on a scale | Standard Deviation 0.48 |
| Tofacitinib Initiators | Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | -0.09 Units on a scale | Standard Deviation 0.51 |
Secondary
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas:dressing,arising,eating,walking,reaching,gripping,hygiene,and carrying out daily activities. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score=sum of domain scores and divided by number of domains answered. Total scores range from 0 to 3 where 0=least difficulty and 3=extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Overall tofacitinib initiators: At Month 6 | -0.04 Units on a scale | Standard Deviation 0.48 |
| Tofacitinib Initiators | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib monotherapy initiators: At Month 6 | -0.03 Units on a scale | Standard Deviation 0.49 |
| Tofacitinib Initiators | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib combination therapy initiators: At Month 6 | -0.06 Units on a scale | Standard Deviation 0.48 |
| Tofacitinib Initiators | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Overall tofacitinib initiators: At Month 12 | -0.06 Units on a scale | Standard Deviation 0.51 |
| Tofacitinib Initiators | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib monotherapy initiators: At Month 12 | -0.04 Units on a scale | Standard Deviation 0.5 |
| Tofacitinib Initiators | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib combination therapy initiators: At Month 12 | -0.07 Units on a scale | Standard Deviation 0.52 |
Secondary
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | -4.03 Units on a scale | Standard Deviation 25.98 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | -6.73 Units on a scale | Standard Deviation 26.14 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | -3.53 Units on a scale | Standard Deviation 25.17 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | -5.46 Units on a scale | Standard Deviation 26.16 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | -3.70 Units on a scale | Standard Deviation 28.02 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | -3.63 Units on a scale | Standard Deviation 26.29 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | 0.28 Units on a scale | Standard Deviation 24.23 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | -4.31 Units on a scale | Standard Deviation 26.69 |
Secondary
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for overall tofa initiators and participants who initiated tofacitinib as either monotherapy or as combination therapy.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Overall tofacitinib initiators: At Month 6 | -3.84 Units on a scale | Standard Deviation 26.06 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib monotherapy initiators: At Month 6 | -2.37 Units on a scale | Standard Deviation 26.4 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib combination therapy initiators: At Month 6 | -4.97 Units on a scale | Standard Deviation 25.74 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Overall tofacitinib initiators: At Month 12 | -3.36 Units on a scale | Standard Deviation 26.26 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib monotherapy initiators: At Month 12 | -2.49 Units on a scale | Standard Deviation 24.85 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib combination therapy initiators: At Month 12 | -4.01 Units on a scale | Standard Deviation 27.28 |
Secondary
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation
Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 6 | -4.84 Units on a scale | Standard Deviation 26.45 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 6 | -3.04 Units on a scale | Standard Deviation 26.73 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 6 | -4.08 Units on a scale | Standard Deviation 24.74 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 12 | -4.98 Units on a scale | Standard Deviation 25.33 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 12 | -3.08 Units on a scale | Standard Deviation 26.98 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 12 | -2.15 Units on a scale | Standard Deviation 25.91 |
Secondary
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose
Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | -3.89 Units on a scale | Standard Deviation 27.17 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg: At Month 6 | -3.65 Units on a scale | Standard Deviation 24.79 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | -3.52 Units on a scale | Standard Deviation 26.12 |
| Tofacitinib Initiators | Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg: At Month 12 | -2.84 Units on a scale | Standard Deviation 26.98 |
Secondary
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | -5.71 Units on a scale | Standard Deviation 28.49 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | -5.17 Units on a scale | Standard Deviation 28.06 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | -8.03 Units on a scale | Standard Deviation 29.83 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | -7.30 Units on a scale | Standard Deviation 28.73 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | -4.77 Units on a scale | Standard Deviation 28.02 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | -5.91 Units on a scale | Standard Deviation 28.03 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | -7.09 Units on a scale | Standard Deviation 29.14 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | -8.18 Units on a scale | Standard Deviation 26.49 |
Secondary
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 6 | -5.44 Units on a scale | Standard Deviation 29.31 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 6 | -5.13 Units on a scale | Standard Deviation 29.07 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 6 | -6.80 Units on a scale | Standard Deviation 27.42 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 12 | -8.16 Units on a scale | Standard Deviation 28.39 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 12 | -4.48 Units on a scale | Standard Deviation 28.56 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 12 | -5.27 Units on a scale | Standard Deviation 27.1 |
Secondary
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | -5.93 Units on a scale | Standard Deviation 29.01 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 6 | -6.53 Units on a scale | Standard Deviation 28.58 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | -8.02 Units on a scale | Standard Deviation 27.96 |
| Tofacitinib Initiators | Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 12 | -3.79 Units on a scale | Standard Deviation 28.81 |
Secondary
Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
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)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 6 | -4.92 Units on a scale | Standard Deviation 30.18 |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators: At Month 6 | -6.35 Units on a scale | Standard Deviation 27.37 |
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 12 | -5.69 Units on a scale | Standard Deviation 28.16 |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 12 | -4.18 Units on a scale | Standard Deviation 28.09 |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators: At Month 12 | -6.84 Units on a scale | Standard Deviation 28.18 |
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 6 | -5.72 Units on a scale | Standard Deviation 28.64 |
Secondary
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*ln (ESR \[mm/hour\] + 0.014\*PtGA \[mm\]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of \<=3.2 indicated LDA or remission. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | 13.8 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | 18.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | 18.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | 11.5 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | 15.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | 22.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | 25.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | 11.4 Percentage of participants |
Secondary
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation
DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*ln (ESR \[mm/hour\] + 0.014\*PtGA \[mm\]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of \<=3.2 indicated LDA or remission. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | 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 | Initiation period: 2018-2020: At Month 6 | 14.0 Percentage of participants |
| Tofacitinib Initiators | 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 | Initiation period: 2012-2014: At Month 6 | 12.2 Percentage of participants |
| Tofacitinib Initiators | 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 | Initiation period: 2015-2017: At Month 6 | 14.6 Percentage of participants |
| Tofacitinib Initiators | 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 | Initiation period: 2012-2014: At Month 12 | 12.6 Percentage of participants |
| Tofacitinib Initiators | 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 | Initiation period: 2015-2017: At Month 12 | 16.7 Percentage of participants |
| Tofacitinib Initiators | 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 | Initiation period: 2018-2020: At Month 12 | 16.5 Percentage of participants |
Secondary
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose
DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*ln (ESR \[mm/hour\] + 0.014\*PtGA \[mm\]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of \<=3.2 indicated LDA or remission. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | 15.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | 15.5 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 6 | 14.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 12 | 18.2 Percentage of participants |
Secondary
Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. Components included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and patient's global assessment (PtGA) recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\]), higher scores=more disease activity. DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28)+0.28\*sqrt (SJC28)+0.70\*ln (ESR \[mm/hour\]+0.014\*PtGA \[mm\]; where, ln=natural logarithm, sqrt=square root of. Total score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \<=3.2 indicated LDA or remission. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy, participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators: At Month 6 | 13.8 Percentage of participants |
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 6 | 13.7 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 6 | 13.7 Percentage of participants |
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 12 | 15.5 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 12 | 16.4 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy: At Month 12 | 14.7 Percentage of participants |
Secondary
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
mACR20 response: \>= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | 19.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | 21.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | 25.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | 24.5 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | 22.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | 25.5 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | 26.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | 20.5 Percentage of participants |
Secondary
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation
mACR20 response: \>= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 6 | 19.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 12 | 19.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 6 | 24.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 6 | 21.5 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 12 | 27.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 12 | 22.4 Percentage of participants |
Secondary
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose
mACR20 response: \>= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 6 | 21.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | 23.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | 24.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 12 | 22.1 Percentage of participants |
Secondary
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | 14.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | 15.5 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | 9.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | 11.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | 12.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | 10.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | 10.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | 12.3 Percentage of participants |
Secondary
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 6 | 11.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 6 | 10.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 6 | 11.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 12 | 12.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 12 | 10.8 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 12 | 7.8 Percentage of participants |
Secondary
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 12 | 9.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | 13.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 6 | 11.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | 12.3 Percentage of participants |
Secondary
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | 5.1 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | 6.8 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | 7.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | 4.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | 5.1 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | 6.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | 5.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | 4.7 Percentage of participants |
Secondary
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 12 | 5.8 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 12 | 5.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 6 | 5.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 6 | 4.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 6 | 6.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 12 | 3.7 Percentage of participants |
Secondary
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | 5.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 6 | 5.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | 5.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 12 | 4.8 Percentage of participants |
Secondary
Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 6 | 21.4 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators: At Month 6 | 21.9 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 6 | 20.8 Percentage of participants |
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 12 | 22.4 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 12 | 21.2 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators: At Month 12 | 23.3 Percentage of participants |
Secondary
Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 12 | 10.4 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 12 | 9.6 Percentage of participants |
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 6 | 11.4 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 6 | 11.2 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators: At Month 6 | 11.5 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators: At Month 12 | 11.0 Percentage of participants |
Secondary
Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 6 | 5.3 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 6 | 5.0 Percentage of participants |
| Tofacitinib Initiators | 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 | Overall tofacitinib initiators: At Month 12 | 5.0 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib monotherapy initiators: At Month 12 | 5.7 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators: At Month 6 | 5.5 Percentage of participants |
| Tofacitinib Initiators | 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 | Tofacitinib combination therapy initiators: At Month 12 | 4.4 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=2.8 indicated remission. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy including second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.
Time frame: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | 8.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | 10.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | 7.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | 10.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | 13.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | 20.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | 10.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | 7.9 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=2.8 indicated remission. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Time frame: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib combination therapy initiators: At Month 6 | 9.1 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Overall tofacitinib initiators: At Month 6 | 8.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib monotherapy initiators: At Month 6 | 8.8 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Overall tofacitinib initiators: At Month 12 | 10.1 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib monotherapy initiators: At Month 12 | 9.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators | Tofacitinib combination therapy initiators: At Month 12 | 10.4 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=2.8 indicated remission. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Time frame: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 6 | 8.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 6 | 9.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 6 | 9.5 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 12 | 9.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 12 | 10.9 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 12 | 9.2 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=2.8 indicated remission. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Time frame: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | 9.5 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 6 | 10.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | 11.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 12 | 10.3 Percentage of participants |
Secondary
Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as \<=20 mm on 100 mm VAS scale in those participants who had pain \>20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 6 | 18.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 6 | 26.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 12 | 15.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 6 | 22.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Fourth line therapy: At Month 6 | 16.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Overall tofacitinib therapy: At Month 12 | 19.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Second line therapy: At Month 12 | 34.2 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy | Third line therapy: At Month 12 | 22.8 Percentage of participants |
Secondary
Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as \<=20 mm on 100 mm VAS scale in those participants who had pain \>20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | Tofacitinib monotherapy initiators: At Month 6 | 18.3 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | Tofacitinib monotherapy initiators: At Month 12 | 17.5 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | Tofacitinib combination therapy initiators: At Month 12 | 20.1 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | Overall tofacitinib initiators: At Month 6 | 18.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | Tofacitinib combination therapy initiators: At Month 6 | 19.1 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy | Overall tofacitinib initiators: At Month 12 | 19.0 Percentage of participants |
Secondary
Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as \<=20 mm on 100 mm VAS scale in those participants who had pain \>20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 6 | 19.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 6 | 15.8 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 6 | 20.0 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2012-2014: At Month 12 | 16.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2015-2017: At Month 12 | 20.6 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation | Initiation period: 2018-2020: At Month 12 | 18.9 Percentage of participants |
Secondary
Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as \<=20 mm on 100 mm VAS scale in those participants who had pain \>20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Time frame: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)
Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 6 | 20.7 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 6 | 19.4 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose | Tofacitinib 5 mg BID: At Month 12 | 21.1 Percentage of participants |
| Tofacitinib Initiators | Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose | Tofacitinib 11 mg QD: At Month 12 | 19.5 Percentage of participants |