Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.

Comparative Effectiveness of Tumor Necrosis Factor (TNF) Inhibitors and Tofacitinib, Overall, by Line of Therapy and by Combination Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04721821

Enrollment

7807

Registered

2021-01-25

Start date

2021-01-22

Completion date

2021-11-29

Last updated

2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis Rheumatoid

Brief summary

This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.

Interventions

DRUGTofacitinib

Patients who received Tofacitinib for RA

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis * Have a 6 and / or 12-month follow-up visit (with +/- 2 month window) * Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit

Exclusion criteria

* Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall	Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to (\<=)10 in participants with moderate or high disease activity CDAI greater than (\>) 10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Month 6 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy	Month 6 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy	Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall	Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Month 12 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy	Month 12 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.

Secondary

Measure	Time frame	Description
Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mACR 20/50/70 response was defined as response greater than or equal to( \>=) 20 percent (%), 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively 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 modified Health Assessment Questionnaire (mHAQ) \[scored from 0 to 3, higher scores indicated worsening of function\]. Propensity score method was used for analysis of the outcome measure.
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively 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 mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.
Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively 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 mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively 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 mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively 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 mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\sqrt (PJC28) + 0.28\sqrt (SJC28) + 0.70\In (ESR) + 0.014\PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\sqrt (PJC28) + 0.28\sqrt (SJC28) + 0.70\In (ESR) + 0.014\PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\sqrt (PJC28) + 0.28\sqrt (SJC28) + 0.70\In (ESR) + 0.014\PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\sqrt (PJC28) + 0.28\sqrt (SJC28) + 0.70\In (ESR) + 0.014\PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\sqrt (PJC28) + 0.28\sqrt (SJC28) + 0.70\In (ESR) + 0.014\PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	HAQ: self-reported, valid assessment of functional disability in RA. 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. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	HAQ: self-reported, valid assessment of functional disability in RA. 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. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	HAQ: self-reported, valid assessment of functional disability in RA. 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. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	HAQ: self-reported, valid assessment of functional disability in RA. 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. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	HAQ: self-reported, valid assessment of functional disability in RA. 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. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study	MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study	MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	Baseline, Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study	MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy	Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study	MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study	MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 millimeter (mm) horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit (for respective arms) post initiation of TNFis during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	Baseline,Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.
Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	Baseline, Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy	Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study	CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.

Countries

United States

Participant flow

Recruitment details

Data of participants diagnosed with rheumatoid arthritis (RA), enrolled in Corrona RA registry, initiated tofacitinib or tumor necrosis factor inhibitors (TNFis) on or after 06-November-2012, after failure with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) treatment, were included.

Pre-assignment details

Data was collected retrospectively for observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years). Data from eligible participants for aforesaid observation period were retrieved and observed in this retrospective study from 22-January-2021 to 29-November-2021 (approximately 10 months).

Participants by arm

Arm	Count
Tofacitinib (6-Month Follow-up) Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.	989
TNFis (6-Month Follow-up) Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.	3,337
Tofacitinib (12-Month Follow-up) Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.	805
TNFis (12-Month Follow-up) Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.	2,676
Total	7,807

Baseline characteristics

Characteristic	TNFis (6-Month Follow-up)	Tofacitinib (12-Month Follow-up)	TNFis (12-Month Follow-up)	Total	Tofacitinib (6-Month Follow-up)
Age, Continuous	58.4 Years STANDARD_DEVIATION 12.8	59.9 Years STANDARD_DEVIATION 11.9	58.9 Years STANDARD_DEVIATION 12.6	59.0 Years STANDARD_DEVIATION 12.5	60.5 Years STANDARD_DEVIATION 11.8
Race/Ethnicity, Customized Asian	55 Participants	6 Participants	40 Participants	107 Participants	6 Participants
Race/Ethnicity, Customized Black	212 Participants	30 Participants	167 Participants	451 Participants	42 Participants
Race/Ethnicity, Customized Hispanic	272 Participants	53 Participants	192 Participants	584 Participants	67 Participants
Race/Ethnicity, Customized Missing	32 Participants	14 Participants	34 Participants	95 Participants	15 Participants
Race/Ethnicity, Customized Other	50 Participants	5 Participants	44 Participants	112 Participants	13 Participants
Race/Ethnicity, Customized White	2,716 Participants	697 Participants	2199 Participants	6458 Participants	846 Participants
Sex: Female, Male Female	2634 Participants	651 Participants	2094 Participants	6183 Participants	804 Participants
Sex: Female, Male Male	703 Participants	152 Participants	580 Participants	1618 Participants	183 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0	0 / 0

Outcome results

Primary

Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.

Time frame: Month 12 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Population: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, Overall Number of Participants Analyzed refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy	123 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy	129 Participants

95% CI: [0.69, 1.32]

Primary

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Time frame: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	57 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	67 Participants

95% CI: [0.81, 1.87]

Primary

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	40 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	52 Participants

95% CI: [0.81, 2.16]

Primary

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Time frame: Month 12 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	44 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	48 Participants

95% CI: [0.7, 1.89]

Primary

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall	104 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall	127 Participants

95% CI: [0.94, 1.76]

Primary

Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy

Time frame: Month 6 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy	166 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy	154 Participants

95% CI: [0.73, 1.27]

Primary

Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Time frame: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	82 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	82 Participants

95% CI: [0.79, 1.67]

Primary

Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy	59 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy	68 Participants

95% CI: [0.79, 1.88]

Primary

Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Time frame: Month 6 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	66 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	48 Participants

95% CI: [0.44, 1.16]

Primary

Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall

CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to (\<=)10 in participants with moderate or high disease activity CDAI greater than (\>) 10 at baseline. Propensity score method was used for analysis of the outcome measure.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall	129 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall	140 Participants

95% CI: [0.82, 1.44]

Secondary

Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.

Time frame: Baseline, Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	-4.39 Units on a scale	Standard Deviation 12.32
TNFis Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	-4.36 Units on a scale	Standard Deviation 11.82
Tofacitinib Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	-5.07 Units on a scale	Standard Deviation 12.08
TNFis Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	-3.49 Units on a scale	Standard Deviation 11.76

Comparison: Month 6 follow-up visit analysis95% CI: [-1.68, 0.56]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.51, 1.99]

Secondary

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.

Time frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	-3.92 Units on a scale	Standard Deviation 13.2
TNFis Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	-4.53 Units on a scale	Standard Deviation 11.94
Tofacitinib Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	-3.28 Units on a scale	Standard Deviation 12.59
TNFis Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	-4.29 Units on a scale	Standard Deviation 12.23

Comparison: Month 6 follow-up visit analysis95% CI: [-2.3, 0.44]

Comparison: Month 12 follow-up visit analysis95% CI: [-2.6, 0.62]

Secondary

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.

Time frame: Baseline,Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	-3.43 Units on a scale	Standard Deviation 12.77
TNFis Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	-2.66 Units on a scale	Standard Deviation 12.59
Tofacitinib Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	-3.30 Units on a scale	Standard Deviation 13.68
TNFis Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	-2.31 Units on a scale	Standard Deviation 12.23

Comparison: Month 6 follow-up visit analysis95% CI: [-1.24, 2.02]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.92, 2.84]

Secondary

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy	-3.26 Units on a scale	Standard Deviation 12.68
TNFis Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy	-3.66 Units on a scale	Standard Deviation 12.41
Tofacitinib Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy	-3.33 Units on a scale	Standard Deviation 13.51
TNFis Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy	-4.39 Units on a scale	Standard Deviation 10.85

Comparison: Month 6 follow-up visit analysis95% CI: [-2.66, 0.45]

Comparison: Month 12 follow-up visit analysis95% CI: [-3.52, 0.05]

Secondary

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	-3.85 Units on a scale	Standard Deviation 12.71
TNFis Overall (6-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	-3.98 Units on a scale	Standard Deviation 12.64
Tofacitinib Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	-3.29 Units on a scale	Standard Deviation 13.28
TNFis Overall (12-Month Follow-up)	Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	-4.39 Units on a scale	Standard Deviation 11.82

Comparison: Month 6 follow-up visit analysis95% CI: [-0.88, 1.31]

Comparison: Month 12 follow-up visit analysis95% CI: [-2.73, -0.27]

Secondary

Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit(for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	46.25 Millimeter	Standard Deviation 30.88
TNFis Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	44.79 Millimeter	Standard Deviation 29.48
Tofacitinib Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	46.20 Millimeter	Standard Deviation 29.8
TNFis Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	46.52 Millimeter	Standard Deviation 30.31

Comparison: Month 6 follow-up visit analysis95% CI: [-3.75, 1.45]

Comparison: Month 12 follow-up visit analysis95% CI: [-3.54, 2.47]

Secondary

Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	45.06 Millimeter	Standard Deviation 29
TNFis Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	48.02 Millimeter	Standard Deviation 29.41
Tofacitinib Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	46.75 Millimeter	Standard Deviation 31.1
TNFis Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	47.62 Millimeter	Standard Deviation 30.17

Comparison: Month 6 follow-up visit analysis95% CI: [-0.66, 5.41]

Comparison: Month 12 follow-up visit analysis95% CI: [-2.69, 4.71]

Secondary

Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	47.11 Millimeter	Standard Deviation 29.08
TNFis Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	48.74 Millimeter	Standard Deviation 28.89
Tofacitinib Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	48.90 Millimeter	Standard Deviation 29.51
TNFis Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	47.01 Millimeter	Standard Deviation 30.62

Comparison: Month 6 follow-up visit analysis95% CI: [-2.36, 4.73]

Comparison: Month 12 follow-up visit analysis95% CI: [-7.36, 1.07]

Secondary

Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	48.31 Millimeter	Standard Deviation 29.28
TNFis Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	45.40 Millimeter	Standard Deviation 29.33
Tofacitinib Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	48.51 Millimeter	Standard Deviation 29.97
TNFis Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	48.64 Millimeter	Standard Deviation 31.2

Comparison: Month 6 follow-up visit analysis95% CI: [-5.02, 1.6]

Comparison: Month 12 follow-up visit analysis95% CI: [-2.85, 4.96]

Secondary

Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	46.23 Millimeter	Standard Deviation 29.42
TNFis Overall (6-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	48.52 Millimeter	Standard Deviation 30.19
Tofacitinib Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	46.75 Millimeter	Standard Deviation 30.71
TNFis Overall (12-Month Follow-up)	Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	46.93 Millimeter	Standard Deviation 29.83

Comparison: Month 6 follow-up visit analysis95% CI: [-0.69, 4.11]

Comparison: Month 12 follow-up visit analysis95% CI: [-2.79, 2.77]

Secondary

HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

HAQ: self-reported, valid assessment of functional disability in RA. 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. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	0.92 Units on a scale	Standard Deviation 0.71
TNFis Overall (6-Month Follow-up)	HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	0.88 Units on a scale	Standard Deviation 0.7
Tofacitinib Overall (12-Month Follow-up)	HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	0.95 Units on a scale	Standard Deviation 0.71
TNFis Overall (12-Month Follow-up)	HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	0.98 Units on a scale	Standard Deviation 0.73

Comparison: Month 6 follow-up visit analysis95% CI: [-0.07, 0.03]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.05, 0.07]

Secondary

HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	1.04 Units on a scale	Standard Deviation 0.7
TNFis Overall (6-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	1.10 Units on a scale	Standard Deviation 0.73
Tofacitinib Overall (12-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	0.99 Units on a scale	Standard Deviation 0.75
TNFis Overall (12-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	1.04 Units on a scale	Standard Deviation 0.76

Comparison: Month 6 follow-up visit analysis95% CI: [-0.09, 0.04]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.06, 0.09]

Secondary

HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	0.98 Units on a scale	Standard Deviation 0.69
TNFis Overall (6-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	1.00 Units on a scale	Standard Deviation 0.67
Tofacitinib Overall (12-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	1.01 Units on a scale	Standard Deviation 0.72
TNFis Overall (12-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	0.99 Units on a scale	Standard Deviation 0.73

Comparison: Month 6 follow-up visit analysis95% CI: [-0.06, 0.07]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.12, 0.06]

Secondary

HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	1.05 Units on a scale	Standard Deviation 0.72
TNFis Overall (6-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	1.10 Units on a scale	Standard Deviation 0.7
Tofacitinib Overall (12-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	1.06 Units on a scale	Standard Deviation 0.74
TNFis Overall (12-Month Follow-up)	HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	1.04 Units on a scale	Standard Deviation 0.75

Comparison: Month 6 follow-up visit analysis95% CI: [-0.08, 0.06]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.11, 0.05]

Secondary

Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	1.02 Units on a scale	Standard Deviation 0.71
TNFis Overall (6-Month Follow-up)	Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	1.06 Units on a scale	Standard Deviation 0.71
Tofacitinib Overall (12-Month Follow-up)	Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	0.98 Units on a scale	Standard Deviation 0.73
TNFis Overall (12-Month Follow-up)	Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	1.05 Units on a scale	Standard Deviation 0.74

Comparison: Month 6 follow-up visit analysis95% CI: [-0.06, 0.04]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.01, 0.09]

Secondary

mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	0.48 Units on a scale	Standard Deviation 0.48
TNFis Overall (6-Month Follow-up)	mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	0.44 Units on a scale	Standard Deviation 0.47
Tofacitinib Overall (12-Month Follow-up)	mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	0.48 Units on a scale	Standard Deviation 0.47
TNFis Overall (12-Month Follow-up)	mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	0.49 Units on a scale	Standard Deviation 0.51

Comparison: Month 6 follow-up visit analysis95% CI: [-0.06, 0.02]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.04, 0.04]

Secondary

mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	0.51 Units on a scale	Standard Deviation 0.49
TNFis Overall (6-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	0.56 Units on a scale	Standard Deviation 0.54
Tofacitinib Overall (12-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	0.51 Units on a scale	Standard Deviation 0.54
TNFis Overall (12-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	0.53 Units on a scale	Standard Deviation 0.53

Comparison: Month 6 follow-up visit analysis95% CI: [-0.05, 0.04]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.06, 0.06]

Secondary

mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	0.50 Units on a scale	Standard Deviation 0.48
TNFis Overall (6-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	0.50 Units on a scale	Standard Deviation 0.5
Tofacitinib Overall (12-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	0.53 Units on a scale	Standard Deviation 0.52
TNFis Overall (12-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	0.49 Units on a scale	Standard Deviation 0.5

Comparison: Month 6 follow-up visit analysis95% CI: [-0.06, 0.04]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.1, 0.03]

Secondary

mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	0.55 Units on a scale	Standard Deviation 0.52
TNFis Overall (6-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	0.56 Units on a scale	Standard Deviation 0.5
Tofacitinib Overall (12-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	0.57 Units on a scale	Standard Deviation 0.55
TNFis Overall (12-Month Follow-up)	mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	0.55 Units on a scale	Standard Deviation 0.52

Comparison: Month 6 follow-up visit analysis95% CI: [-0.05, 0.05]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.07, 0.06]

Secondary

Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	0.51 Units on a scale	Standard Deviation 0.5
TNFis Overall (6-Month Follow-up)	Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	0.53 Units on a scale	Standard Deviation 0.51
Tofacitinib Overall (12-Month Follow-up)	Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	0.52 Units on a scale	Standard Deviation 0.54
TNFis Overall (12-Month Follow-up)	Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	0.53 Units on a scale	Standard Deviation 0.51

Comparison: Month 6 follow-up visit analysis95% CI: [-0.03, 0.04]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.04, 0.05]

Secondary

Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit (for respective arms) post initiation of TNFis during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	1.51 Hours	Standard Deviation 3.12
TNFis Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	1.41 Hours	Standard Deviation 2.74
Tofacitinib Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	1.49 Hours	Standard Deviation 3.3
TNFis Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	1.48 Hours	Standard Deviation 2.95

Comparison: Month 6 follow-up visit analysis95% CI: [-0.51, 0.1]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.42, 0.31]

Secondary

Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	1.41 Hours	Standard Deviation 2.69
TNFis Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	1.46 Hours	Standard Deviation 2.95
Tofacitinib Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	1.39 Hours	Standard Deviation 3.06
TNFis Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	1.62 Hours	Standard Deviation 3.46

Comparison: Month 6 follow-up visit analysis95% CI: [-0.37, 0.32]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.3, 0.59]

Secondary

Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	1.29 Hours	Standard Deviation 2.3
TNFis Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	1.28 Hours	Standard Deviation 2.38
Tofacitinib Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	1.51 Hours	Standard Deviation 3.08
TNFis Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	1.53 Hours	Standard Deviation 3.39

Comparison: Month 6 follow-up visit analysis95% CI: [-0.34, 0.32]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.69, 0.31]

Secondary

Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	1.38 Hours	Standard Deviation 2.6
TNFis Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	1.48 Hours	Standard Deviation 2.99
Tofacitinib Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	1.62 Hours	Standard Deviation 3.24
TNFis Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	1.41 Hours	Standard Deviation 3.05

Comparison: Month 6 follow-up visit analysis95% CI: [-0.4, 0.43]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.74, 0.29]

Secondary

Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	1.39 Hours	Standard Deviation 2.73
TNFis Overall (6-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	1.56 Hours	Standard Deviation 3.07
Tofacitinib Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	1.39 Hours	Standard Deviation 2.96
TNFis Overall (12-Month Follow-up)	Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	1.51 Hours	Standard Deviation 3.26

Comparison: Month 6 follow-up visit analysis95% CI: [-0.16, 0.4]

Comparison: Month 12 follow-up visit analysis95% CI: [-0.21, 0.45]

Secondary

Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	62 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	56 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	39 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	45 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.66, 1.52]

Comparison: Month 12 follow-up visit analysis95% CI: [0.64, 1.74]

Secondary

Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	36 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	34 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	24 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy	24 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.73, 2.27]

Comparison: Month 12 follow-up visit analysis95% CI: [0.63, 2.23]

Secondary

Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	23 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	32 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	12 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	17 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.8, 2.94]

Comparison: Month 12 follow-up visit analysis95% CI: [0.76, 3.87]

Secondary

Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Time frame: Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	24 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	20 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	14 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	16 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.41, 1.67]

Comparison: Month 12 follow-up visit analysis95% CI: [0.62, 3.07]

Secondary

Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	54 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	64 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	44 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	40 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.94, 2.15]

Comparison: Month 12 follow-up visit analysis95% CI: [0.68, 1.84]

Secondary

Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.

Time frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	202 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	197 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	129 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	143 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.73, 1.21]

Comparison: Month 12 follow-up visit analysis95% CI: [0.77, 1.39]

Secondary

Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy

Time frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	121 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	131 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	94 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	86 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.84, 1.59]

Comparison: Month 12 follow-up visit analysis95% CI: [0.65, 1.32]

Secondary

Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Time frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	94 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	82 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	73 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	75 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.53, 1.11]

Comparison: Month 12 follow-up visit analysis95% CI: [0.72, 1.61]

Secondary

Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy	97 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy	95 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy	62 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy	62 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.64, 1.32]

Comparison: Month 12 follow-up visit analysis95% CI: [0.69, 1.64]

Secondary

Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	197 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	213 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	174 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	135 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.9, 1.45]

Comparison: Month 12 follow-up visit analysis95% CI: [0.54, 0.94]

Secondary

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Population: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, Overall Number of Participants Analyzed refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	69 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	78 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	55 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	56 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.79, 1.58]

Comparison: Month 12 follow-up visit analysis95% CI: [0.6, 1.35]

Secondary

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.

Time frame: Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Population: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, Overall Number of Participants Analyzed refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	34 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	41 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	26 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	23 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.81, 2.24]

Comparison: Month 12 follow-up visit analysis95% CI: [0.5, 1.62]

Secondary

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.

Population: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, Overall Number of Participants Analyzed refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	28 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	36 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	20 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	30 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.77, 2.29]

Comparison: Month 12 follow-up visit analysis95% CI: [0.82, 2.71]

Secondary

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Population: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, Overall Number of Participants Analyzed refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	29 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	23 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	23 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	24 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.57, 1.99]

Comparison: Month 12 follow-up visit analysis95% CI: [0.49, 1.75]

Secondary

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.

Population: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, Overall Number of Participants Analyzed refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	61 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	71 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	53 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	61 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.8, 1.66]

Comparison: Month 12 follow-up visit analysis95% CI: [0.75, 1.65]

Secondary

Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	107 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	96 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	73 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	71 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.64, 1.19]

Comparison: Month 12 follow-up visit analysis95% CI: [0.6, 1.26]

Secondary

Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	62 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	56 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	39 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy	36 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.6, 1.38]

Comparison: Month 12 follow-up visit analysis95% CI: [0.56, 1.5]

Secondary

Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	44 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	40 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	28 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	25 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.55, 1.46]

Comparison: Month 12 follow-up visit analysis95% CI: [0.47, 1.51]

Secondary

Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Time frame: Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	43 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	42 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	30 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	27 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.62, 1.73]

Comparison: Month 12 follow-up visit analysis95% CI: [0.5, 1.6]

Secondary

Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	98 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	102 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	79 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	79 Participants

Comparison: Month 6 follow-up visit analysis95% CI: [0.73, 1.34]

Comparison: Month 12 follow-up visit analysis95% CI: [0.66, 1.34]

Secondary

Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively 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 mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 20	137 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 70	47 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 50	90 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 20	151 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 70	35 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 50	85 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 50	59 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 20	111 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 70	34 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 20	107 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 70	26 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy	mACR 50	59 Participants

Comparison: Month 6 follow-up visit analysis: mACR 2095% CI: [0.86, 1.45]

Comparison: Month 6 follow-up visit analysis: mACR 5095% CI: [0.67, 1.26]

Comparison: Month 6 follow-up visit analysis: mACR 7095% CI: [0.44, 1.09]

Comparison: Month 12 follow-up visit analysis: mACR 2095% CI: [0.74, 1.38]

Comparison: Month 12 follow-up visit analysis: mACR 5095% CI: [0.69, 1.52]

Comparison: Month 12 follow-up visit analysis: mACR 7095% CI: [0.46, 1.33]

Secondary

Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 20	91 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 70	24 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 50	47 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 20	91 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 70	16 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 50	39 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 50	30 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 20	65 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 70	10 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 20	57 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 70	14 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy	mACR 50	32 Participants

Comparison: Month 6 follow-up visit analysis: mACR 2095% CI: [0.76, 1.49]

Comparison: Month 6 follow-up visit analysis: mACR 5095% CI: [0.55, 1.37]

Comparison: Month 6 follow-up visit analysis: mACR 7095% CI: [0.32, 1.2]

Comparison: Month 12 follow-up visit analysis: mACR 2095% CI: [0.59, 1.3]

Comparison: Month 12 follow-up visit analysis: mACR 5095% CI: [0.65, 1.86]

Comparison: Month 12 follow-up visit analysis: mACR 7095% CI: [0.62, 3.28]

Secondary

Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 20	66 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 70	13 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 50	36 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 20	66 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 70	12 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 50	37 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 50	21 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 20	42 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 70	12 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 20	33 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 70	9 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy	mACR 50	19 Participants

Comparison: Month 6 follow-up visit analysis: mACR 2095% CI: [0.78, 1.77]

Comparison: Month 6 follow-up visit analysis: mACR 5095% CI: [0.71, 1.95]

Comparison: Month 6 follow-up visit analysis: mACR 7095% CI: [0.45, 2.39]

Comparison: Month 12 follow-up visit analysis: mACR 2095% CI: [0.5, 1.4]

Comparison: Month 12 follow-up visit analysis: mACR 5095% CI: [0.49, 1.83]

Comparison: Month 12 follow-up visit analysis: mACR 7095% CI: [0.33, 1.95]

Secondary

Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 20	63 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 70	15 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 50	38 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 20	56 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 70	10 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 50	25 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 50	20 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 20	46 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 70	12 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 20	43 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 70	8 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	mACR 50	19 Participants

Comparison: Month 6 follow-up visit analysis: mACR 2095% CI: [0.59, 1.34]

Comparison: Month 6 follow-up visit analysis: mACR 5095% CI: [0.39, 1.15]

Comparison: Month 6 follow-up visit analysis: mACR 7095% CI: [0.34, 1.83]

Comparison: Month 12 follow-up visit analysis: mACR 2095% CI: [0.56, 1.42]

Comparison: Month 12 follow-up visit analysis: mACR 5095% CI: [0.46, 1.8]

Comparison: Month 12 follow-up visit analysis: mACR 7095% CI: [0.19, 1.48]

Secondary

Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

mACR 20/50/70 response was defined as response greater than or equal to( \>=) 20 percent (%), 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively 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 modified Health Assessment Questionnaire (mHAQ) \[scored from 0 to 3, higher scores indicated worsening of function\]. Propensity score method was used for analysis of the outcome measure.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 20	138 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 70	33 Participants
Tofacitinib Overall (6-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 50	73 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 20	143 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 70	32 Participants
TNFis Overall (6-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 50	87 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 50	52 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 20	114 Participants
Tofacitinib Overall (12-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 70	22 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 20	109 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 70	33 Participants
TNFis Overall (12-Month Follow-up)	Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall	mACR 50	63 Participants

Comparison: Month 6 follow-up visit analysis: mACR 2095% CI: [0.8, 1.35]

Comparison: Month 6 follow-up visit analysis: mACR 5095% CI: [0.86, 1.67]

Comparison: Month 6 follow-up visit analysis: mACR 7095% CI: [0.57, 1.54]

Comparison: Month 12 follow-up visit analysis: mACR 2095% CI: [0.77, 1.41]

Comparison: Month 12 follow-up visit analysis: mACR 5095% CI: [0.89, 1.95]

Comparison: Month 12 follow-up visit analysis: mACR 7095% CI: [0.85, 2.6]

Secondary

Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.

Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	42.70 Millimeter	Standard Deviation 29.43
TNFis Overall (6-Month Follow-up)	Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	41.80 Millimeter	Standard Deviation 28.6
Tofacitinib Overall (12-Month Follow-up)	Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	42.74 Millimeter	Standard Deviation 28.97
TNFis Overall (12-Month Follow-up)	Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy	42.87 Millimeter	Standard Deviation 29.33

Comparison: Month 6 follow-up visit analysis95% CI: [-3.94, 1.45]

Comparison: Month 12 follow-up visit analysis95% CI: [-3.61, 2.42]

Secondary

Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	43.62 Millimeter	Standard Deviation 28.79
TNFis Overall (6-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	44.30 Millimeter	Standard Deviation 28.8
Tofacitinib Overall (12-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	43.13 Millimeter	Standard Deviation 29.48
TNFis Overall (12-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy	44.62 Millimeter	Standard Deviation 29.08

Comparison: Month 6 follow-up visit analysis95% CI: [-3.59, 2.82]

Comparison: Month 12 follow-up visit analysis95% CI: [-2.97, 4.49]

Secondary

Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	43.56 Millimeter	Standard Deviation 29.23
TNFis Overall (6-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	42.97 Millimeter	Standard Deviation 27.64
Tofacitinib Overall (12-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	46.11 Millimeter	Standard Deviation 28.41
TNFis Overall (12-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy	41.82 Millimeter	Standard Deviation 28.53

Comparison: Month 6 follow-up visit analysis95% CI: [-4.39, 3.05]

Comparison: Month 12 follow-up visit analysis95% CI: [-9.19, -0.48]

Secondary

Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	43.99 Millimeter	Standard Deviation 29.28
TNFis Overall (6-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	44.89 Millimeter	Standard Deviation 28.54
Tofacitinib Overall (12-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	46.91 Millimeter	Standard Deviation 28.38
TNFis Overall (12-Month Follow-up)	Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy	44.21 Millimeter	Standard Deviation 28.9

Comparison: Month 6 follow-up visit analysis95% CI: [-2.71, 4.38]

Comparison: Month 12 follow-up visit analysis95% CI: [-5.12, 2.95]

Secondary

Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Pain VAS was assessed using 100 millimeter (mm) horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Tofacitinib Overall (6-Month Follow-up)	Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	43.61 Millimeter	Standard Deviation 29.07
TNFis Overall (6-Month Follow-up)	Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	44.33 Millimeter	Standard Deviation 28.8
Tofacitinib Overall (12-Month Follow-up)	Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	43.22 Millimeter	Standard Deviation 29.02
TNFis Overall (12-Month Follow-up)	Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall	43.45 Millimeter	Standard Deviation 29.22

Comparison: Month 6 follow-up visit analysis95% CI: [-2.65, 2.45]

Comparison: Month 12 follow-up visit analysis95% CI: [-2.59, 3.11]

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall

Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall

Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy

Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy

Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy

Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy

Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy

Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall

Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy