Trial Outcomes & Findings for Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy. (NCT NCT04721821)

NCT ID: NCT04721821

Last Updated: 2024-04-12

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

7807 participants

Primary outcome timeframe

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

Results posted on

2024-04-12

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure
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.
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.
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.
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.
Overall Study
STARTED
989
3337
805
2676
Overall Study
COMPLETED
989
3337
805
2676
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

"Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tofacitinib (6-Month Follow-up)
n=989 Participants
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.
TNFis (6-Month Follow-up)
n=3337 Participants
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.
Tofacitinib (12-Month Follow-up)
n=805 Participants
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.
TNFis (12-Month Follow-up)
n=2676 Participants
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.
Total
n=7807 Participants
Total of all reporting groups
Age, Continuous
60.5 Years
STANDARD_DEVIATION 11.8 • n=987 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
58.4 Years
STANDARD_DEVIATION 12.8 • n=3334 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
59.9 Years
STANDARD_DEVIATION 11.9 • n=803 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
58.9 Years
STANDARD_DEVIATION 12.6 • n=2671 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
59.0 Years
STANDARD_DEVIATION 12.5 • n=7795 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
Sex: Female, Male
Female
804 Participants
n=987 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
2634 Participants
n=3337 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
651 Participants
n=803 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
2094 Participants
n=2674 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
6183 Participants
n=7801 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
Sex: Female, Male
Male
183 Participants
n=987 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
703 Participants
n=3337 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
152 Participants
n=803 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
580 Participants
n=2674 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
1618 Participants
n=7801 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
Race/Ethnicity, Customized
White
846 Participants
n=989 Participants
2,716 Participants
n=3337 Participants
697 Participants
n=805 Participants
2199 Participants
n=2676 Participants
6458 Participants
n=7807 Participants
Race/Ethnicity, Customized
Hispanic
67 Participants
n=989 Participants
272 Participants
n=3337 Participants
53 Participants
n=805 Participants
192 Participants
n=2676 Participants
584 Participants
n=7807 Participants
Race/Ethnicity, Customized
Black
42 Participants
n=989 Participants
212 Participants
n=3337 Participants
30 Participants
n=805 Participants
167 Participants
n=2676 Participants
451 Participants
n=7807 Participants
Race/Ethnicity, Customized
Asian
6 Participants
n=989 Participants
55 Participants
n=3337 Participants
6 Participants
n=805 Participants
40 Participants
n=2676 Participants
107 Participants
n=7807 Participants
Race/Ethnicity, Customized
Other
13 Participants
n=989 Participants
50 Participants
n=3337 Participants
5 Participants
n=805 Participants
44 Participants
n=2676 Participants
112 Participants
n=7807 Participants
Race/Ethnicity, Customized
Missing
15 Participants
n=989 Participants
32 Participants
n=3337 Participants
14 Participants
n=805 Participants
34 Participants
n=2676 Participants
95 Participants
n=7807 Participants

PRIMARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=502 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=513 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
140 Participants

PRIMARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=228 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=231 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
66 Participants
48 Participants

PRIMARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=469 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=438 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy
166 Participants
154 Participants

PRIMARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=223 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=222 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy
59 Participants
68 Participants

PRIMARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=310 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=301 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
82 Participants
82 Participants

PRIMARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=419 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=417 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall
104 Participants
127 Participants

PRIMARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=180 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=176 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
44 Participants
48 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=362 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=356 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy
123 Participants
129 Participants

PRIMARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=160 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=165 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
40 Participants
52 Participants

PRIMARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=234 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=240 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
57 Participants
67 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=572 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=565 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=686 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=680 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
53 Participants
61 Participants
61 Participants
71 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=259 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=251 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=317 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=311 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
23 Participants
24 Participants
29 Participants
23 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=474 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=485 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=606 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=604 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
55 Participants
56 Participants
69 Participants
78 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=230 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=236 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=315 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=316 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
20 Participants
30 Participants
28 Participants
36 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=319 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=317 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=414 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=412 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
26 Participants
23 Participants
34 Participants
41 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
-4.39 Units on a scale
Standard Deviation 11.82
-3.85 Units on a scale
Standard Deviation 12.71
-3.98 Units on a scale
Standard Deviation 12.64

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
-2.31 Units on a scale
Standard Deviation 12.23
-3.43 Units on a scale
Standard Deviation 12.77
-2.66 Units on a scale
Standard Deviation 12.59

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
-3.49 Units on a scale
Standard Deviation 11.76
-4.39 Units on a scale
Standard Deviation 12.32
-4.36 Units on a scale
Standard Deviation 11.82

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
-4.39 Units on a scale
Standard Deviation 10.85
-3.26 Units on a scale
Standard Deviation 12.68
-3.66 Units on a scale
Standard Deviation 12.41

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
-4.29 Units on a scale
Standard Deviation 12.23
-3.92 Units on a scale
Standard Deviation 13.20
-4.53 Units on a scale
Standard Deviation 11.94

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=608 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=602 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=731 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=730 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
109 Participants
138 Participants
143 Participants
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
63 Participants
73 Participants
87 Participants
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
33 Participants
33 Participants
32 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=272 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=267 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=333 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=328 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
mACR 20
46 Participants
43 Participants
63 Participants
56 Participants
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
mACR 50
20 Participants
19 Participants
38 Participants
25 Participants
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
mACR 70
12 Participants
8 Participants
15 Participants
10 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=531 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=533 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=666 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=663 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
mACR 20
111 Participants
107 Participants
137 Participants
151 Participants
Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
mACR 50
59 Participants
59 Participants
90 Participants
85 Participants
Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
mACR 70
34 Participants
26 Participants
47 Participants
35 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=244 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=244 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=338 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=340 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
mACR 20
42 Participants
33 Participants
66 Participants
66 Participants
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
mACR 50
21 Participants
19 Participants
36 Participants
37 Participants
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
mACR 70
12 Participants
9 Participants
13 Participants
12 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=341 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=442 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=439 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
mACR 20
65 Participants
57 Participants
91 Participants
91 Participants
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
mACR 50
30 Participants
32 Participants
47 Participants
39 Participants
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
mACR 70
10 Participants
14 Participants
24 Participants
16 Participants

SECONDARY outcome

Timeframe: 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

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 DAS28 ESR \>3.2 at baseline.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=265 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=232 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=314 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=279 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
40 Participants
54 Participants
64 Participants

SECONDARY outcome

Timeframe: 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 DAS28 ESR \>3.2 at baseline.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=112 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=108 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=131 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=149 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
14 Participants
16 Participants
24 Participants
20 Participants

SECONDARY outcome

Timeframe: 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 DAS28 ESR \>3.2 at baseline.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=204 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=205 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=255 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=236 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
39 Participants
45 Participants
62 Participants
56 Participants

SECONDARY outcome

Timeframe: 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

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 DAS28 ESR \>3.2 at baseline.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=95 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=88 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=129 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=129 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
12 Participants
17 Participants
23 Participants
32 Participants

SECONDARY outcome

Timeframe: 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

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 DAS28 ESR \>3.2 at baseline.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=151 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=143 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=201 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=167 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
24 Participants
36 Participants
34 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
1.05 Units on a scale
Standard Deviation 0.74
1.02 Units on a scale
Standard Deviation 0.71
1.06 Units on a scale
Standard Deviation 0.71

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
1.06 Units on a scale
Standard Deviation 0.74
1.04 Units on a scale
Standard Deviation 0.75
1.05 Units on a scale
Standard Deviation 0.72
1.10 Units on a scale
Standard Deviation 0.70

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
0.95 Units on a scale
Standard Deviation 0.71
0.98 Units on a scale
Standard Deviation 0.73
0.92 Units on a scale
Standard Deviation 0.71
0.88 Units on a scale
Standard Deviation 0.70

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
1.01 Units on a scale
Standard Deviation 0.72
0.99 Units on a scale
Standard Deviation 0.73
0.98 Units on a scale
Standard Deviation 0.69
1.00 Units on a scale
Standard Deviation 0.67

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
0.99 Units on a scale
Standard Deviation 0.75
1.04 Units on a scale
Standard Deviation 0.76
1.04 Units on a scale
Standard Deviation 0.70
1.10 Units on a scale
Standard Deviation 0.73

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=507 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=504 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=614 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=618 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
174 Participants
135 Participants
197 Participants
213 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=226 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=221 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=269 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=278 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
73 Participants
75 Participants
94 Participants
82 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=429 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=452 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=543 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=539 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
129 Participants
143 Participants
202 Participants
197 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=199 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=201 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=269 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=286 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy
62 Participants
62 Participants
97 Participants
95 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=290 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=281 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=379 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=381 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy
94 Participants
86 Participants
121 Participants
131 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
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
0.53 Units on a scale
Standard Deviation 0.51
0.51 Units on a scale
Standard Deviation 0.50
0.53 Units on a scale
Standard Deviation 0.51

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
0.57 Units on a scale
Standard Deviation 0.55
0.55 Units on a scale
Standard Deviation 0.52
0.55 Units on a scale
Standard Deviation 0.52
0.56 Units on a scale
Standard Deviation 0.50

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
0.48 Units on a scale
Standard Deviation 0.47
0.49 Units on a scale
Standard Deviation 0.51
0.48 Units on a scale
Standard Deviation 0.48
0.44 Units on a scale
Standard Deviation 0.47

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
0.53 Units on a scale
Standard Deviation 0.52
0.49 Units on a scale
Standard Deviation 0.50
0.50 Units on a scale
Standard Deviation 0.48
0.50 Units on a scale
Standard Deviation 0.50

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
0.51 Units on a scale
Standard Deviation 0.54
0.53 Units on a scale
Standard Deviation 0.53
0.51 Units on a scale
Standard Deviation 0.49
0.56 Units on a scale
Standard Deviation 0.54

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
43.22 Millimeter
Standard Deviation 29.02
43.45 Millimeter
Standard Deviation 29.22
43.61 Millimeter
Standard Deviation 29.07
44.33 Millimeter
Standard Deviation 28.80

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
46.91 Millimeter
Standard Deviation 28.38
44.21 Millimeter
Standard Deviation 28.90
43.99 Millimeter
Standard Deviation 29.28
44.89 Millimeter
Standard Deviation 28.54

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
42.74 Millimeter
Standard Deviation 28.97
42.87 Millimeter
Standard Deviation 29.33
42.70 Millimeter
Standard Deviation 29.43
41.80 Millimeter
Standard Deviation 28.60

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
46.11 Millimeter
Standard Deviation 28.41
41.82 Millimeter
Standard Deviation 28.53
43.56 Millimeter
Standard Deviation 29.23
42.97 Millimeter
Standard Deviation 27.64

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy
43.13 Millimeter
Standard Deviation 29.48
44.62 Millimeter
Standard Deviation 29.08
43.62 Millimeter
Standard Deviation 28.79
44.30 Millimeter
Standard Deviation 28.80

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=472 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=476 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=564 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=586 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
79 Participants
79 Participants
98 Participants
102 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=214 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=209 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=261 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=265 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
30 Participants
27 Participants
43 Participants
42 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=409 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=428 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=524 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=520 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
73 Participants
71 Participants
107 Participants
96 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=186 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=191 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=256 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=258 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
28 Participants
25 Participants
44 Participants
40 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=265 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=265 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=348 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=348 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
39 Participants
36 Participants
62 Participants
56 Participants

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
46.75 Millimeter
Standard Deviation 30.71
46.93 Millimeter
Standard Deviation 29.83
46.23 Millimeter
Standard Deviation 29.42
48.52 Millimeter
Standard Deviation 30.19

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
48.51 Millimeter
Standard Deviation 29.97
48.64 Millimeter
Standard Deviation 31.20
48.31 Millimeter
Standard Deviation 29.28
45.40 Millimeter
Standard Deviation 29.33

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
46.20 Millimeter
Standard Deviation 29.80
46.52 Millimeter
Standard Deviation 30.31
46.25 Millimeter
Standard Deviation 30.88
44.79 Millimeter
Standard Deviation 29.48

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
48.90 Millimeter
Standard Deviation 29.51
47.01 Millimeter
Standard Deviation 30.62
47.11 Millimeter
Standard Deviation 29.08
48.74 Millimeter
Standard Deviation 28.89

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
46.75 Millimeter
Standard Deviation 31.10
47.62 Millimeter
Standard Deviation 30.17
45.06 Millimeter
Standard Deviation 29.00
48.02 Millimeter
Standard Deviation 29.41

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
1.39 Hours
Standard Deviation 2.96
1.51 Hours
Standard Deviation 3.26
1.39 Hours
Standard Deviation 2.73
1.56 Hours
Standard Deviation 3.07

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
1.62 Hours
Standard Deviation 3.24
1.41 Hours
Standard Deviation 3.05
1.38 Hours
Standard Deviation 2.60
1.48 Hours
Standard Deviation 2.99

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
1.49 Hours
Standard Deviation 3.30
1.48 Hours
Standard Deviation 2.95
1.51 Hours
Standard Deviation 3.12
1.41 Hours
Standard Deviation 2.74

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
1.51 Hours
Standard Deviation 3.08
1.53 Hours
Standard Deviation 3.39
1.29 Hours
Standard Deviation 2.30
1.28 Hours
Standard Deviation 2.38

SECONDARY outcome

Timeframe: 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

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.

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.

Outcome measures

Outcome measures
Measure
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
1.39 Hours
Standard Deviation 3.06
1.62 Hours
Standard Deviation 3.46
1.41 Hours
Standard Deviation 2.69
1.46 Hours
Standard Deviation 2.95

Adverse Events

Tofacitinib (6 Month Follow-up)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

TNFis (6 Month Follow-up)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Tofacitinib (12 Month Follow-up)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

TNFis (12 Month Follow-up)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
  • Publication restrictions are in place

Restriction type: OTHER