Trial Outcomes & Findings for Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis (NCT NCT03387423)

Last Updated: 2024-10-21

Results Overview

Treatment escalations was defined as participants who switched to another disease modifying antirheumatic drug (DMARD) or combination of DMARDs when compared to the last visit. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime towards e.g.a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, example (e.g.) from combination therapy to monotherapy. One participant can fall into more than 1 type of escalation.

Recruitment status

COMPLETED

Target enrollment

1459 participants

Primary outcome timeframe

From date of first prescription of tofacitinib up to 24 Months

Results posted on

2024-10-21

Participant Flow

Total 1518 participants were screened in this observational study, out of which 1459 eligible participants were enrolled and 59 we excluded. Out of these 59 participants, 30 participants were excluded due to retrospective screening failure and data review meeting decision as the type of therapy (monotherapy or combination therapy) was not defined and 29 participants were not eligible as their treatment with Tofacitinib was not started.

Data from German participants with rheumatoid arthritis (RA) who initiated treatment with Tofacitinib or switched to other therapies from initial tofacitinib therapy in real world setting were observed for 24 months in this non-interventional observational study.

Participant milestones

Participant milestones
Measure	Tofacitinib Monotherapy Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Overall Study STARTED	779	440	111	129
Overall Study COMPLETED	521	304	90	105
Overall Study NOT COMPLETED	258	136	21	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib Monotherapy Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Overall Study Lost to Follow-up	16	12	1	0
Overall Study Other	0	3	0	0
Overall Study Administrative Reason	166	89	17	19
Overall Study Revocation Consent	76	32	3	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib Monotherapy n=779 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=440 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Total n=1459 Participants Total of all reporting groups
Age, Customized 18-44 years	90 Participants n=779 Participants	43 Participants n=440 Participants	13 Participants n=111 Participants	22 Participants n=129 Participants	168 Participants n=1459 Participants
Age, Customized 45-64 years	389 Participants n=779 Participants	287 Participants n=440 Participants	75 Participants n=111 Participants	61 Participants n=129 Participants	812 Participants n=1459 Participants
Age, Customized More than or equal to (>=) 65 years	300 Participants n=779 Participants	110 Participants n=440 Participants	23 Participants n=111 Participants	46 Participants n=129 Participants	479 Participants n=1459 Participants
Sex: Female, Male Female	627 Participants n=779 Participants	307 Participants n=440 Participants	90 Participants n=111 Participants	91 Participants n=129 Participants	1115 Participants n=1459 Participants
Sex: Female, Male Male	152 Participants n=779 Participants	133 Participants n=440 Participants	21 Participants n=111 Participants	38 Participants n=129 Participants	344 Participants n=1459 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From date of first prescription of tofacitinib up to 24 Months

Population: Full analysis set (FAS) included all participants who received at least 1 dose of tofacitinib and had at least 1 set of post-baseline measurements.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants With Treatment Escalations Any escalation	341 Participants	156 Participants	111 Participants	123 Participants
Number of Participants With Treatment Escalations Step-up/switch	249 Participants	130 Participants	101 Participants	48 Participants
Number of Participants With Treatment Escalations Step-down	29 Participants	51 Participants	39 Participants	91 Participants
Number of Participants With Treatment Escalations Treatment termination	109 Participants	2 Participants	7 Participants	26 Participants

PRIMARY outcome

Timeframe: From date of first prescription of tofacitinib up to 24 Months

Population: FAS included all participants who received at least 1 dose of tofacitinib and had at least 1 set of post-baseline measurements. Here" Number analyzed" signifies participants evaluable for specific rows.

Time to treatment escalation was defined as time in days from escalation visit date to next escalation visit date. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, e.g. from combination therapy to monotherapy. Number of participants with total number of each type of treatment escalations during the study (step-up/switch, step-down, treatment termination along with all escalations) are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=341 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=156 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=123 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Time to Treatment Escalation Step up/switch: 4 Treatment escalation	208.25 Days Standard Deviation 172.07	—	185.40 Days Standard Deviation 108.18	231.50 Days Standard Deviation 129.40
Time to Treatment Escalation Step down: 2 Treatment escalation	—	480.00 Days Standard Deviation 5.66	—	—
Time to Treatment Escalation Treatment termination: 1 Treatment escalation	336.52 Days Standard Deviation 228.53	137.50 Days Standard Deviation 64.35	520.80 Days Standard Deviation 264.57	485.70 Days Standard Deviation 246.06
Time to Treatment Escalation All Escalations: 1 Treatment escalation	288.21 Days Standard Deviation 210.01	278.47 Days Standard Deviation 188.96	221.95 Days Standard Deviation 154.99	308.11 Days Standard Deviation 190.70
Time to Treatment Escalation All Escalations: 2 Treatment escalation	240.39 Days Standard Deviation 162.67	219.47 Days Standard Deviation 152.66	234.58 Days Standard Deviation 154.80	239.20 Days Standard Deviation 166.14
Time to Treatment Escalation All Escalations: 3 Treatment escalation	175.56 Days Standard Deviation 117.36	258.92 Days Standard Deviation 153.07	216.84 Days Standard Deviation 137.04	193.35 Days Standard Deviation 126.70
Time to Treatment Escalation All Escalations: 4 Treatment escalation	211.43 Days Standard Deviation 133.53	—	202.88 Days Standard Deviation 101.76	186.33 Days Standard Deviation 60.67
Time to Treatment Escalation All Escalations: 5 Treatment escalation	92.00 Days	—	94.00 Days Standard Deviation 4.36	160.00 Days
Time to Treatment Escalation All Escalations: 6 Treatment escalation	—	—	—	106.00 Days
Time to Treatment Escalation Step up/switch: 1 Treatment escalation	303.14 Days Standard Deviation 214.45	286.58 Days Standard Deviation 196.41	240.05 Days Standard Deviation 169.23	273.15 Days Standard Deviation 164.79
Time to Treatment Escalation Step up/switch: 2 Treatment escalation	236.51 Days Standard Deviation 170.99	242.07 Days Standard Deviation 156.23	248.78 Days Standard Deviation 169.24	258.74 Days Standard Deviation 191.11
Time to Treatment Escalation Step up/switch: 3 Treatment escalation	196.88 Days Standard Deviation 129.53	194.71 Days Standard Deviation 116.10	196.24 Days Standard Deviation 109.94	188.33 Days Standard Deviation 119.09
Time to Treatment Escalation Step up/switch: 5 Treatment escalation	—	—	95.50 Days Standard Deviation 4.95	—
Time to Treatment Escalation Step down: 1 Treatment escalation	304.55 Days Standard Deviation 222.48	381.24 Days Standard Deviation 212.79	392.46 Days Standard Deviation 238.26	362.63 Days Standard Deviation 201.10

SECONDARY outcome

Timeframe: From date of first tofacitinib prescription up to date of first step-up treatment escalation (maximum up to 24 months)

Population: FAS included all participants who received at least 1 dose of tofacitinib and had at least 1 set of post-baseline measurements.

Time to first step-up treatment escalation was defined for participants who experienced a treatment step-up and was measured as date of first treatment step up escalation minus (-) date of first prescription of tofacitinib. Treatment step-up was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Time to First Step Up Treatment Escalation	611.33 Days Standard Error 10.27	599.17 Days Standard Error 12.38	268.07 Days Standard Error 19.86	555.69 Days Standard Error 21.68

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

Population: Secondary FAS (SFAS): all participants who received at least 1 dose of tofacitinib, had \>=1 set of post-baseline values \& whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row.

SDAI was calculated using the following formula: SDAI = Tender Joint Count (TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 centimetre \[cm\] scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + C-reactive protein (CRP) (milligram per decilitre \[mg/dL\]). TJC28 joints included shoulders, elbows, wrists, metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm visual analogue scale (VAS) scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of less than or equal to (\<=11) indicates LDA.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	256 Participants	127 Participants	22 Participants	56 Participants
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	281 Participants	164 Participants	31 Participants	63 Participants
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	225 Participants	134 Participants	16 Participants	48 Participants
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	221 Participants	131 Participants	17 Participants	45 Participants
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	197 Participants	109 Participants	8 Participants	42 Participants
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	159 Participants	114 Participants	9 Participants	39 Participants
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	166 Participants	99 Participants	8 Participants	37 Participants
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	149 Participants	111 Participants	6 Participants	41 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

Population: SFAS: all participants who received at least 1 dose of tofacitinib, had \>=1 set of post-baseline values \& whose data was collected while taking tofacitinib. A participant was considered on tofacitinib at a given timepoint if tofacitinib was not terminated/paused at time of the visit/event. "Number Analyzed"=participants evaluable for specified rows. All participants reported under "Number of Participants Analyzed' contributed data but may not have evaluable data for every row.

CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<= 10 indicates LDA.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	348 Participants	197 Participants	40 Participants	71 Participants
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	205 Participants	141 Participants	13 Participants	46 Participants
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	315 Participants	162 Participants	28 Participants	65 Participants
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	293 Participants	172 Participants	25 Participants	57 Participants
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	266 Participants	154 Participants	23 Participants	56 Participants
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	254 Participants	144 Participants	13 Participants	49 Participants
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	204 Participants	130 Participants	11 Participants	45 Participants
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	199 Participants	135 Participants	9 Participants	51 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.70\* natural log (ln) (ESR in \[millimeter per hour \[mm/ hour\]) + 0.014\*(PtGA in cm). PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR \<= 3.2 indicates LDA.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	200 Participants	131 Participants	16 Participants	39 Participants
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	161 Participants	107 Participants	11 Participants	32 Participants
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	253 Participants	155 Participants	32 Participants	57 Participants
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	224 Participants	131 Participants	21 Participants	49 Participants
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	204 Participants	116 Participants	15 Participants	42 Participants
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	157 Participants	108 Participants	12 Participants	37 Participants
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	147 Participants	103 Participants	7 Participants	32 Participants
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	138 Participants	101 Participants	8 Participants	32 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in mm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP \<= 3.2 indicates LDA.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	172 Participants	117 Participants	10 Participants	42 Participants
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	174 Participants	110 Participants	8 Participants	38 Participants
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	156 Participants	117 Participants	6 Participants	41 Participants
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	202 Participants	115 Participants	10 Participants	42 Participants
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	308 Participants	175 Participants	38 Participants	65 Participants
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	280 Participants	136 Participants	24 Participants	60 Participants
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	250 Participants	144 Participants	19 Participants	54 Participants
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	234 Participants	137 Participants	17 Participants	47 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

ACR-EULAR Boolean remission criteria was defined as when participant had ACR remission =1 if; TJC28 \<=1, SJC28 \<=1, CRP \<=1mg/dL and PtGA \<= 2 cm on a 0 to 10 cm scale, where higher values indicate greater affection due to disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	22 Participants	13 Participants	0 Participants	6 Participants
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	11 Participants	11 Participants	0 Participants	2 Participants
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	13 Participants	12 Participants	1 Participants	2 Participants
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	21 Participants	15 Participants	1 Participants	8 Participants
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	25 Participants	9 Participants	1 Participants	0 Participants
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	28 Participants	12 Participants	1 Participants	2 Participants
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	11 Participants	5 Participants	1 Participants	4 Participants
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	11 Participants	7 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

SDAI was calculated using the following formula: SDAI = (TJC28) + (SJC28) + (PtGA in cm) + (PhGA in cm) + (CRP in mg/dL). TJC28 joints included shoulders, elbows, wrists, MCP and PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=3.3 indicates remission.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	72 Participants	47 Participants	4 Participants	21 Participants
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	71 Participants	40 Participants	2 Participants	22 Participants
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	78 Participants	40 Participants	4 Participants	16 Participants
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	73 Participants	43 Participants	2 Participants	15 Participants
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	48 Participants	34 Participants	3 Participants	15 Participants
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	48 Participants	39 Participants	2 Participants	15 Participants
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	51 Participants	34 Participants	4 Participants	17 Participants
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	46 Participants	38 Participants	2 Participants	21 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	68 Participants	49 Participants	8 Participants	23 Participants
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	69 Participants	53 Participants	3 Participants	26 Participants
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	94 Participants	65 Participants	8 Participants	28 Participants
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	96 Participants	61 Participants	5 Participants	27 Participants
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	84 Participants	59 Participants	5 Participants	19 Participants
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	98 Participants	51 Participants	6 Participants	18 Participants
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	67 Participants	55 Participants	6 Participants	17 Participants
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	68 Participants	51 Participants	4 Participants	20 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR score of \<2.6 indicates remission.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	102 Participants	76 Participants	8 Participants	23 Participants
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	139 Participants	80 Participants	9 Participants	27 Participants
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	136 Participants	90 Participants	6 Participants	22 Participants
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	162 Participants	101 Participants	17 Participants	45 Participants
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	143 Participants	97 Participants	9 Participants	32 Participants
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	100 Participants	76 Participants	5 Participants	25 Participants
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	92 Participants	65 Participants	6 Participants	22 Participants
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	80 Participants	68 Participants	5 Participants	26 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP score of \<2.6 indicates remission.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	238 Participants	125 Participants	27 Participants	55 Participants
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	208 Participants	104 Participants	19 Participants	52 Participants
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	151 Participants	88 Participants	6 Participants	35 Participants
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	122 Participants	88 Participants	4 Participants	37 Participants
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	199 Participants	103 Participants	14 Participants	41 Participants
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	196 Participants	110 Participants	13 Participants	38 Participants
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	137 Participants	90 Participants	8 Participants	34 Participants
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	133 Participants	83 Participants	5 Participants	33 Participants

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 9	-1.67 Units on a scale Standard Deviation 1.61	-1.56 Units on a scale Standard Deviation 1.37	-1.23 Units on a scale Standard Deviation 1.66	-1.50 Units on a scale Standard Deviation 1.51
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 12	-1.74 Units on a scale Standard Deviation 1.64	-1.76 Units on a scale Standard Deviation 1.41	-1.81 Units on a scale Standard Deviation 1.38	-1.57 Units on a scale Standard Deviation 1.49
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 15	-1.69 Units on a scale Standard Deviation 1.54	-1.84 Units on a scale Standard Deviation 1.45	-2.15 Units on a scale Standard Deviation 0.74	-1.70 Units on a scale Standard Deviation 1.53
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 18	-1.63 Units on a scale Standard Deviation 1.55	-1.84 Units on a scale Standard Deviation 1.44	-2.15 Units on a scale Standard Deviation 0.93	-1.68 Units on a scale Standard Deviation 1.47
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 21	-1.62 Units on a scale Standard Deviation 1.59	-1.72 Units on a scale Standard Deviation 1.54	-1.81 Units on a scale Standard Deviation 1.32	-1.87 Units on a scale Standard Deviation 1.60
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 24	-1.65 Units on a scale Standard Deviation 1.63	-1.77 Units on a scale Standard Deviation 1.47	-1.85 Units on a scale Standard Deviation 0.90	-1.87 Units on a scale Standard Deviation 1.51
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 3	-1.47 Units on a scale Standard Deviation 1.49	-1.36 Units on a scale Standard Deviation 1.34	-1.03 Units on a scale Standard Deviation 1.77	-1.69 Units on a scale Standard Deviation 1.48
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 6	-1.52 Units on a scale Standard Deviation 1.48	-1.49 Units on a scale Standard Deviation 1.41	-0.81 Units on a scale Standard Deviation 1.58	-1.80 Units on a scale Standard Deviation 1.39

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of(TJC28) + 0.28\*square root of(SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 9	-1.82 Units on a scale Standard Deviation 1.50	-1.64 Units on a scale Standard Deviation 1.22	-1.15 Units on a scale Standard Deviation 1.45	-1.66 Units on a scale Standard Deviation 1.36
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 12	-1.90 Units on a scale Standard Deviation 1.53	-1.79 Units on a scale Standard Deviation 1.35	-1.86 Units on a scale Standard Deviation 1.32	-1.68 Units on a scale Standard Deviation 1.28
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 18	-1.84 Units on a scale Standard Deviation 1.49	-1.85 Units on a scale Standard Deviation 1.37	-2.06 Units on a scale Standard Deviation 1.51	-1.62 Units on a scale Standard Deviation 1.34
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 24	-1.84 Units on a scale Standard Deviation 1.49	-1.79 Units on a scale Standard Deviation 1.40	-1.48 Units on a scale Standard Deviation 1.04	-1.92 Units on a scale Standard Deviation 1.31
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 3	-1.55 Units on a scale Standard Deviation 1.40	-1.40 Units on a scale Standard Deviation 1.28	-1.04 Units on a scale Standard Deviation 1.42	-1.63 Units on a scale Standard Deviation 1.35
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 6	-1.72 Units on a scale Standard Deviation 1.43	-1.52 Units on a scale Standard Deviation 1.36	-0.94 Units on a scale Standard Deviation 1.38	-1.90 Units on a scale Standard Deviation 1.26
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 15	-1.89 Units on a scale Standard Deviation 1.44	-1.77 Units on a scale Standard Deviation 1.26	-2.13 Units on a scale Standard Deviation 1.49	-1.75 Units on a scale Standard Deviation 1.39
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 21	-1.81 Units on a scale Standard Deviation 1.49	-1.74 Units on a scale Standard Deviation 1.47	-1.67 Units on a scale Standard Deviation 1.27	-1.84 Units on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24

The duration of morning stiffness was determined by asking the following questions: "When you wake up in the morning, do you currently suffer from morning stiffness?" "How long does the morning stiffness last from the time you wake up?". The change from baseline in duration of morning stiffness was calculated as: morning stiffness at time point -morning stiffness at baseline.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 9	-37.00 Minutes Standard Deviation 97.53	-36.16 Minutes Standard Deviation 113.11	-38.43 Minutes Standard Deviation 70.31	-29.55 Minutes Standard Deviation 62.24
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 12	-42.11 Minutes Standard Deviation 100.95	-35.88 Minutes Standard Deviation 105.09	-27.18 Minutes Standard Deviation 45.05	-32.59 Minutes Standard Deviation 57.80
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 15	-37.20 Minutes Standard Deviation 123.17	-42.20 Minutes Standard Deviation 118.62	-36.20 Minutes Standard Deviation 44.26	-35.12 Minutes Standard Deviation 61.01
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 18	-41.01 Minutes Standard Deviation 106.86	-36.57 Minutes Standard Deviation 107.59	-47.95 Minutes Standard Deviation 63.25	-34.95 Minutes Standard Deviation 58.77
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 21	-31.24 Minutes Standard Deviation 137.43	-28.71 Minutes Standard Deviation 50.98	-42.47 Minutes Standard Deviation 58.09	-31.13 Minutes Standard Deviation 65.98
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 24	-33.12 Minutes Standard Deviation 61.16	-38.17 Minutes Standard Deviation 116.88	-26.36 Minutes Standard Deviation 65.33	-39.88 Minutes Standard Deviation 61.46
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 3	-27.71 Minutes Standard Deviation 86.53	-22.23 Minutes Standard Deviation 108.98	-44.73 Minutes Standard Deviation 164.97	-26.48 Minutes Standard Deviation 45.41
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 6	-29.00 Minutes Standard Deviation 110.51	-25.74 Minutes Standard Deviation 126.36	-35.18 Minutes Standard Deviation 60.26	-28.64 Minutes Standard Deviation 48.50

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24

The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points).The functional capacity (%) is calculated by (total score\*100) divided by (2\*number of valid responses). The change from baseline was calculated at each time point as functional capacity at timepoint - functional capacity at baseline.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 3	6.73 Percent functional capacity Standard Deviation 15.08	5.31 Percent functional capacity Standard Deviation 16.05	8.82 Percent functional capacity Standard Deviation 15.75	6.52 Percent functional capacity Standard Deviation 14.29
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 6	8.73 Percent functional capacity Standard Deviation 17.14	6.12 Percent functional capacity Standard Deviation 17.23	10.82 Percent functional capacity Standard Deviation 18.57	7.02 Percent functional capacity Standard Deviation 15.08
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 9	8.49 Percent functional capacity Standard Deviation 16.60	6.45 Percent functional capacity Standard Deviation 15.83	12.23 Percent functional capacity Standard Deviation 17.22	5.33 Percent functional capacity Standard Deviation 15.40
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 12	8.41 Percent functional capacity Standard Deviation 16.69	7.78 Percent functional capacity Standard Deviation 17.22	13.59 Percent functional capacity Standard Deviation 19.05	7.26 Percent functional capacity Standard Deviation 14.58
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 15	8.42 Percent functional capacity Standard Deviation 17.64	8.56 Percent functional capacity Standard Deviation 17.33	13.83 Percent functional capacity Standard Deviation 19.05	6.55 Percent functional capacity Standard Deviation 14.96
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 18	8.20 Percent functional capacity Standard Deviation 17.75	8.15 Percent functional capacity Standard Deviation 17.42	17.90 Percent functional capacity Standard Deviation 18.26	5.90 Percent functional capacity Standard Deviation 14.65
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 21	9.46 Percent functional capacity Standard Deviation 19.24	7.43 Percent functional capacity Standard Deviation 17.42	16.00 Percent functional capacity Standard Deviation 17.36	4.23 Percent functional capacity Standard Deviation 13.27
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 24	9.38 Percent functional capacity Standard Deviation 18.50	8.78 Percent functional capacity Standard Deviation 17.61	15.21 Percent functional capacity Standard Deviation 20.50	7.18 Percent functional capacity Standard Deviation 16.00

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points). The functional capacity \[%\] is calculated by (total score\*100)/ (2\*number of valid responses). Functional remission in FFbH was defined as functional capacity \> 83 %.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3	174 Participants	114 Participants	18 Participants	47 Participants
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6	157 Participants	102 Participants	17 Participants	40 Participants
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24	92 Participants	62 Participants	8 Participants	26 Participants
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9	139 Participants	84 Participants	14 Participants	34 Participants
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12	116 Participants	85 Participants	9 Participants	31 Participants
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15	122 Participants	84 Participants	6 Participants	25 Participants
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18	99 Participants	80 Participants	7 Participants	26 Participants
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21	99 Participants	65 Participants	7 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24

The EQ-5D-3L is a standardised instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group (German weights) assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 9	0.133 Units on a scale Standard Deviation 0.204	0.118 Units on a scale Standard Deviation 0.222	0.120 Units on a scale Standard Deviation 0.188	0.054 Units on a scale Standard Deviation 0.206
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 3	0.119 Units on a scale Standard Deviation 0.205	0.109 Units on a scale Standard Deviation 0.195	0.079 Units on a scale Standard Deviation 0.197	0.102 Units on a scale Standard Deviation 0.159
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 6	0.134 Units on a scale Standard Deviation 0.214	0.110 Units on a scale Standard Deviation 0.217	0.090 Units on a scale Standard Deviation 1.197	0.100 Units on a scale Standard Deviation 0.192
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 12	0.142 Units on a scale Standard Deviation 0.210	0.122 Units on a scale Standard Deviation 0.221	0.087 Units on a scale Standard Deviation 0.228	0.095 Units on a scale Standard Deviation 0.173
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 15	0.137 Units on a scale Standard Deviation 0.223	0.135 Units on a scale Standard Deviation 0.207	0.149 Units on a scale Standard Deviation 0.199	0.102 Units on a scale Standard Deviation 0.259
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 18	0.140 Units on a scale Standard Deviation 0.206	0.127 Units on a scale Standard Deviation 0.209	0.169 Units on a scale Standard Deviation 0.237	0.098 Units on a scale Standard Deviation 0.196
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 21	0.134 Units on a scale Standard Deviation 0.207	0.122 Units on a scale Standard Deviation 0.210	0.151 Units on a scale Standard Deviation 0.202	0.106 Units on a scale Standard Deviation 0.206
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 24	0.133 Units on a scale Standard Deviation 0.207	0.137 Units on a scale Standard Deviation 0.205	0.163 Units on a scale Standard Deviation 0.199	0.125 Units on a scale Standard Deviation 0.226

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24

The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 12	5.78 Units on a scale Standard Deviation 10.69	5.54 Units on a scale Standard Deviation 9.88	6.61 Units on a scale Standard Deviation 10.73	4.24 Units on a scale Standard Deviation 10.49
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 3	4.83 Units on a scale Standard Deviation 9.63	3.59 Units on a scale Standard Deviation 8.57	3.71 Units on a scale Standard Deviation 9.99	3.35 Units on a scale Standard Deviation 9.12
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 6	5.57 Units on a scale Standard Deviation 10.11	4.25 Units on a scale Standard Deviation 10.11	5.68 Units on a scale Standard Deviation 8.79	2.58 Units on a scale Standard Deviation 9.28
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 9	5.63 Units on a scale Standard Deviation 9.87	4.44 Units on a scale Standard Deviation 9.46	5.34 Units on a scale Standard Deviation 10.93	1.78 Units on a scale Standard Deviation 10.53
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 15	5.63 Units on a scale Standard Deviation 10.57	5.34 Units on a scale Standard Deviation 9.94	6.33 Units on a scale Standard Deviation 12.14	3.31 Units on a scale Standard Deviation 10.05
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 18	5.96 Units on a scale Standard Deviation 10.51	5.91 Units on a scale Standard Deviation 9.92	13.05 Units on a scale Standard Deviation 8.93	3.44 Units on a scale Standard Deviation 8.04
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 21	6.32 Units on a scale Standard Deviation 11.17	6.65 Units on a scale Standard Deviation 9.85	11.43 Units on a scale Standard Deviation 10.62	4.02 Units on a scale Standard Deviation 9.87
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24 Change at Month 24	6.03 Units on a scale Standard Deviation 10.36	6.72 Units on a scale Standard Deviation 9.31	12.69 Units on a scale Standard Deviation 8.40	4.49 Units on a scale Standard Deviation 9.68

SECONDARY outcome

Timeframe: At 12 and 24 months

Population: FAS included all participants who received at least 1 dose of tofacitinib and have at least 1 set of post-baseline measurements. Here" Number Analyzed" = participants evaluable for specified rows.

Drug survival was assessed using Kaplan-Meier methodology. For participants who terminated tofacitinib, the drug survival status was recorded as (status = 1 and time = termination date tofacitinib - date of initiation on tofacitinib) and for participants who do not terminate tofacitinib (status = 0 and time = date of final visit - date of initiation on tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Mean Number of Days of Drug Survival at Months 12 and 24 Month 12	339.83 Days Standard Error 5.73	341.17 Days Standard Error 7.18	233.30 Days Standard Error 14.00	337.36 Days Standard Error 12.48
Mean Number of Days of Drug Survival at Months 12 and 24 Month 24	534.49 Days Standard Error 11.35	542.15 Days Standard Error 14.28	317.51 Days Standard Error 25.09	532.39 Days Standard Error 25.94

SECONDARY outcome

Timeframe: Months 3, 6, 9, 12, 15, 18, 21 and 24

Satisfaction with treatment was assessed on a 5-point Likert scale (where 0 = extremely dissatisfied, 1= dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = extremely satisfied) in response to the question "How satisfied are you with the drugs that you have received for your arthritis since your last visit?".

Outcome measures

Outcome measures
Measure	Tofacitinib Monotherapy n=725 Participants Participants who were on tofacitinib monotherapy treatment throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+Methotrexate (MTX) Combination Therapy n=413 Participants Participants who were on combination therapy of tofacitinib with Methotrexate (MTX) throughout the study as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy n=111 Participants Participants who were on tofacitinib monotherapy and then switched to tofacitinib +MTX combination therapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.	Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy n=129 Participants Participants who were on combination therapy of tofacitinib+MTX and then switched to tofacitinib monotherapy as part of their routine clinical treatment were followed up for 24 months from the date of first tofacitinib prescription. Treatment dose and frequency of follow-up were decided by the treating physician.
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24 · Neither satisfied nor dissatisfied	19 Participants	16 Participants	3 Participants	3 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6 · Extremely satisfied	107 Participants	69 Participants	5 Participants	22 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9 · Neither satisfied nor dissatisfied	54 Participants	23 Participants	7 Participants	10 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12 · Extremely satisfied	94 Participants	51 Participants	4 Participants	17 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15 · Extremely satisfied	98 Participants	52 Participants	6 Participants	22 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18 · Extremely dissatisfied	14 Participants	11 Participants	0 Participants	2 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18 · Dissatisfied	12 Participants	5 Participants	1 Participants	2 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18 · Neither satisfied nor dissatisfied	32 Participants	17 Participants	0 Participants	7 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18 · Satisfied	156 Participants	107 Participants	12 Participants	29 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 18 · Extremely satisfied	94 Participants	54 Participants	7 Participants	23 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21 · Satisfied	137 Participants	88 Participants	9 Participants	29 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24 · Extremely dissatisfied	17 Participants	13 Participants	2 Participants	6 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24 · Dissatisfied	5 Participants	2 Participants	1 Participants	0 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24 · Satisfied	135 Participants	73 Participants	5 Participants	26 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 24 · Extremely satisfied	81 Participants	54 Participants	3 Participants	22 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3 · Extremely dissatisfied	43 Participants	19 Participants	5 Participants	11 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3 · Dissatisfied	41 Participants	26 Participants	15 Participants	5 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3 · Neither satisfied nor dissatisfied	107 Participants	63 Participants	22 Participants	20 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3 · Satisfied	290 Participants	166 Participants	32 Participants	43 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 3 · Extremely satisfied	98 Participants	57 Participants	9 Participants	23 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6 · Extremely dissatisfied	39 Participants	13 Participants	2 Participants	11 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6 · Dissatisfied	22 Participants	13 Participants	9 Participants	5 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6 · Neither satisfied nor dissatisfied	78 Participants	51 Participants	13 Participants	10 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 6 · Satisfied	242 Participants	137 Participants	32 Participants	41 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9 · Extremely dissatisfied	27 Participants	11 Participants	0 Participants	4 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9 · Dissatisfied	15 Participants	9 Participants	7 Participants	7 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9 · Satisfied	218 Participants	137 Participants	26 Participants	36 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 9 · Extremely satisfied	108 Participants	60 Participants	8 Participants	23 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12 · Extremely dissatisfied	17 Participants	21 Participants	4 Participants	5 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12 · Dissatisfied	14 Participants	5 Participants	0 Participants	1 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12 · Neither satisfied nor dissatisfied	38 Participants	21 Participants	7 Participants	11 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 12 · Satisfied	207 Participants	117 Participants	19 Participants	38 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15 · Extremely dissatisfied	16 Participants	10 Participants	0 Participants	4 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15 · Dissatisfied	15 Participants	6 Participants	1 Participants	0 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15 · Neither satisfied nor dissatisfied	37 Participants	24 Participants	5 Participants	8 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 15 · Satisfied	170 Participants	105 Participants	13 Participants	26 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21 · Extremely dissatisfied	12 Participants	9 Participants	0 Participants	4 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21 · Dissatisfied	11 Participants	4 Participants	1 Participants	1 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21 · Neither satisfied nor dissatisfied	20 Participants	15 Participants	0 Participants	2 Participants
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24 Month 21 · Extremely satisfied	97 Participants	47 Participants	5 Participants	17 Participants

Adverse Events

Tofacitinib Monotherapy

Serious events: 141 serious events

Other events: 402 other events

Deaths: 6 deaths

Tofacitinib+Methotrexate (MTX) Combination Therapy

Serious events: 69 serious events

Other events: 240 other events

Deaths: 5 deaths

Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy

Serious events: 24 serious events

Other events: 81 other events

Deaths: 0 deaths

Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy

Serious events: 27 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

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