Trial Outcomes & Findings for Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients (NCT NCT04079920)

Last Updated: 2025-06-08

Results Overview

Remission is defined as DAS28-4 CRP less than (\<) 2.6 and DAS28-4 CRP \< 3.2 corresponds to LDA. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: tender joint count (TJC) and swollen joint count ((SJC) \[both out of 28 evaluated joints\], CRP milligram per liter (mg/l) and Patient's Global Assessment of Arthritis Disease Activity (PtGA) recorded on 100 millimeter (mm) visual analogue scale (VAS) (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). DAS28-4 CRP is calculated as: 0.56 \* square root (sqrt) (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm.

Recruitment status

COMPLETED

Target enrollment

198 participants

Primary outcome timeframe

Month 6

Results posted on

2025-06-08

Participant Flow

Participants diagnosed with moderate-to-severe active rheumatoid arthritis who initiated tofacitinib in real-world and in a non-interventional setting in Greece were observed in this study.

Participant milestones

Participant milestones
Measure	Tofacitinib Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved summary of product characteristics (SmPC) were observed in this study. The recommended dosage was tofacitinib 5 milligrams (mg) tablet twice daily.
Overall Study STARTED	198
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Tofacitinib Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved summary of product characteristics (SmPC) were observed in this study. The recommended dosage was tofacitinib 5 milligrams (mg) tablet twice daily.
Overall Study Adverse event, not related to study drug	2
Overall Study Adverse event related to study drug	10
Overall Study Death	2
Overall Study Lost to Follow-up	22
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	11

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Age, Continuous	58.9 Years STANDARD_DEVIATION 11.70 • n=198 Participants
Sex: Female, Male Female	157 Participants n=198 Participants
Sex: Female, Male Male	41 Participants n=198 Participants

PRIMARY outcome

Timeframe: Month 6

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number of Participants Analyzed" signifies number of participants evaluable and who contributed to data for this outcome measure. Missing components were imputed by carrying forward the last non-missing post-baseline value.

Outcome measures

Outcome measures
Measure	Tofacitinib n=152 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP) Remission	29.6 Percentage of participants
Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP) LDA	41.4 Percentage of participants

SECONDARY outcome

Timeframe: Month 12

Remission is defined as DAS28-4 CRP \< 2.6 and DAS28-4 CRP \< 3.2 corresponds to LDA. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC and SJC assessed using 28 joints, CRP (mg/l) and PtGA recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). DAS28-4 CRP is calculated as: 0.56 \* (sqrt) (TJC28) + 0.28 \* sqrt (SJC28) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm.

Outcome measures

Outcome measures
Measure	Tofacitinib n=150 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP Remission	33.3 Percentage of participants
Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP LDA	55.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points. Missing components were imputed by carrying forward the last non-missing post-baseline value.

DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC and SJC both assessed using 28 joints, CRP (mg/l) and PtGA recorded recorded on VAS scores (mm). DAS28-4 CRP is calculated as: 0.56 \* sqrt (TJC28) + 0.28 \* sqrt (SJC28) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC and SJC both assessed using 28 joints, ESR using mm/ hour and PtGA in recorded on VAS (mm). DAS28-4 ESR is calculated as: 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA where In = natural logarithm. The calculated range of DAS28-4 CRP and DAS 28-4 ESR is 0 (no disease activity) to 10 (maximal disease activity). A decrease from baseline in score indicates improvement of disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=192 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) Change at Month 3: DAS28-4(CRP)	-1.25 Units on a scale Standard Deviation 1.38
Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) Change at Month 6: DAS28-4(CRP)	-1.47 Units on a scale Standard Deviation 1.40
Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) Change at Month 12: DAS28-4(CRP)	-1.73 Units on a scale Standard Deviation 1.46
Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) Change at Month 3: DAS 28-4 (ESR)	-1.15 Units on a scale Standard Deviation 1.47
Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) Change at Month 6:DAS 28-4 (ESR)	-1.42 Units on a scale Standard Deviation 1.58
Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) Change at Month 12: DAS 28-4 (ESR)	-1.58 Units on a scale Standard Deviation 1.61

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points. If one or two domains had missing data, score was calculated as: sum of non-missing domain scores/number of non-missing domains.

HAQ-DI is a participant-reported assessment which assess the degree of difficulty a participant had experienced during the last week in 8 domains/categories of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3, where 0 indicates least difficulty and 3 indicates extreme difficulty.

Outcome measures

Outcome measures
Measure	Tofacitinib n=190 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12 Change at Month 3	-0.25 Units on a scale Standard Deviation 0.56
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12 Change at Month 6	-0.40 Units on a scale Standard Deviation 0.60
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12 Change at Month 12	-0.40 Units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with SDAI at specified time points. No imputation was applied for missing values in any visit.

Remission is defined as SDAI \<=3.3. SDAI is a composite end point, calculated at each time point using the formula: as TJC + SJC both assessed using 28 joints + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + Physician's Global Assessment of Health \[PhGA\] (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity)+ CRP (mg/dL).

Outcome measures

Outcome measures
Measure	Tofacitinib n=190 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12 Month 3	12 Participants
Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12 Month 6	14 Participants
Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12 Month 12	22 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with CDAI at specified time points. No imputation was applied for missing values in any visit.

Remission is defined as CDAI \<=2.8. CDAI is a composite end point, calculated based on each time-point using TJC + SJC both assessed using 28 joints + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + PhGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity).

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12 Month 3	11 Participants
Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12 Month 6	16 Participants
Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12 Month 12	24 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with DAS 28-4 (ESR) at specified time points. No imputation was applied for missing values in any visit.

DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC, SJC both assessed using 28 joints, ESR (mm/h) and PtGA (mm) (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher score indicates high disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* sqrt (TJC28) + 0.28 \* sqrt (SJC28) + 0.70\* In (ESR) + 0.014\* (PtGA); where ln = natural logarithm. DAS28-4 (ESR) score of \<2.6 indicates remission.

Outcome measures

Outcome measures
Measure	Tofacitinib n=192 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12 Month 3	25 Participants
Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12 Month 6	30 Participants
Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12 Month 12	40 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with DAS28-4 (CRP) at specified time points. No imputation was applied for missing values in any visit.

DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC, SJC both assessed using 28 joints, CRP (mg/l) and PtGA (mm) (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher score indicates high disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. DAS28-4 (CRP) score of \<2.6 indicates remission.

Outcome measures

Outcome measures
Measure	Tofacitinib n=190 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12 Month 3	31 Participants
Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12 Month 6	45 Participants
Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12 Month 12	49 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with SDAI at specified time points. No imputation was applied for missing values in any visit.

LDA is defined as SDAI \<=11. SDAI is a composite end point, calculated at each time point using the formula: as TJC + SJC (both assessed using 28 joints) + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + PhGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity)+ CRP (mg/dL).

Outcome measures

Outcome measures
Measure	Tofacitinib n=190 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12 Month 3	54 Participants
Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12 Month 6	63 Participants
Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12 Month 12	74 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with CDAI at specified time points. No imputation was applied for missing values in any visit.

LDA is defined as CDAI \<=10. CDAI is a composite end point, calculated based on each time-point using TJC + SJC (both assessed using 28 joints) + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + PhGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12 Month 3	56 Participants
Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12 Month 6	61 Participants
Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12 Month 12	73 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with DAS 28-4 (ESR) at specified time points. No imputation was applied for missing values in any visit.

DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC, SJC (both assessed using 28 joints), ESR (mm/h) and PtGA (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher score indicates high disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* sqrt (TJC28) + 0.28 \* sqrt (SJC28) + 0.70\* In(ESR) + 0.014\* (PtGA); where ln = natural logarithm. DAS28-4 (ESR) score of \<3.2 indicates LDA.

Outcome measures

Outcome measures
Measure	Tofacitinib n=192 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12 Month 3	46 Participants
Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12 Month 6	62 Participants
Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12 Month 12	65 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with DAS 28-4 (CRP) at specified time points. No imputation was applied for missing values in any visit.

LDA is defined as DAS28-4(CRP) score of \<3.2. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC, SJC (both assessed using 28 joints), CRP (mg/l) and PtGA (mm) (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56\*sqrt (TJC) + 0.28\*sqrt (SJC) + 0.36\*ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. DAS28-4 (CRP) score of \<3.2 indicates LDA.

Outcome measures

Outcome measures
Measure	Tofacitinib n=190 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12 Month 3	59 Participants
Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12 Month 6	63 Participants
Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12 Month 12	82 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points. If one or two domains had missing data, score was calculated as: sum of non-missing domain scores/number of non-missing domains.

Outcome measures

Outcome measures
Measure	Tofacitinib n=190 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12 Month 3	56.6 Percentage of participants
Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12 Month 6	65.9 Percentage of participants
Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12 Month 12	71.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with EQ-5D score at specified time points. Missing weighted dimension scores were replaced by the mean of non-missing ones.

EQ-5D is a standardized instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three responses and the participant is asked to select the response that best describes them. The responses are scored 1-3 where 1 indicates no problems, 2 indicates some problems and 3 indicates unable to perform normal activities. The score (1 to 3), for each dimension is weighted based on United Kingdom (UK) data (Dolan et al 1995). An algorithm was applied to calculate the total EQ-5D health state score. Maximum and minimum score value were 1 and -0.6 respectively. Higher score indicates better health state.

Outcome measures

Outcome measures
Measure	Tofacitinib n=193 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12 Change at Month 3	0.18 Units on a scale Standard Error 0.02
Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12 Change at Month 6	0.23 Units on a scale Standard Error 0.02
Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12 Change at Month 12	0.23 Units on a scale Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

Population: FAS population was analyzed. All participants reported under "Number of Participants analyzed" =number of participant evaluable and contributed data to table; however, may not have evaluable data for every row. "Number Analyzed"=number of participants evaluable at specified time points. If more than 50% of the items were non-missing, then score was prorated by multiplying the sum of the subscale by the number of items in the subscale, then dividing by the number of items actually answered.

FACIT-fatigue questionnaire score consists of 13 self-evaluated questions. Each question is scored from 0 to 4; the sum of all responses resulted in the FACIT-fatigue score of 0 (maximum fatigue) to 52 (no fatigue). A higher score represents better participant status.

Outcome measures

Outcome measures
Measure	Tofacitinib n=195 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12 Change at Month 3	6.8 Units on a scale Standard Error 0.66
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12 Change at Month 6	7.21 Units on a scale Standard Error 0.65
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12 Change at Month 12	8.71 Units on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: Baseline, Day 1 and 2 of Months 3, 6 and 12

Population: FAS population was analyzed. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with morning stiffness evaluable at specified time points. No imputation was applied for missing values in any visit.

The duration of morning stiffness is determined by asking the following questions: "Over the last 2 days, when did you wake in the morning? Over the last 2 days, when were you able to resume your normal activities without stiffness?". Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.

Outcome measures

Outcome measures
Measure	Tofacitinib n=153 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 Change at Month 3: Day 1	-25.7 Minutes Standard Deviation 43.02
Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 Change at Month 6: Day 1	-29.9 Minutes Standard Deviation 42.68
Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 Change at Month 12: Day 1	-34.2 Minutes Standard Deviation 44.27
Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 Change at Month 3: Day 2	-30.42 Minutes Standard Deviation 46.9
Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 Change at Month 6: Day 2	-33.8 Minutes Standard Deviation 43.50
Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 Change at Month 12: Day 2	-37.04 Minutes Standard Deviation 41.89

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to table; however, may not have evaluable data for every row. Here, "Number Analyzed"= number of participants evaluable at specified time points.

WPAI: 6-item questionnaire \& scores are derived for four domains:absenteeism, presenteeism,work productivity loss \& activity impairment.Question (Q)2 asked participants to indicate number of hours missed due to health problems in past 7 days. Q4 asked participants to indicate number of hours they worked in past 7 days.Q5 asked participants the degree to which their health affected productivity while working in past 7 days,on scale ranging from 0-10, Where 0 = health problems had no effect on their work \& 10=health problems completely prevented participant from working. Q6 asked participants to indicate the degree to which their health affected their regular activities in past 7 days.Absenteeism=(Q2/\[Q2 + Q4\])\*100.Presenteeism=(Q5/10)\*100.Work Production Loss={(Q2/\[Q2 + Q4\])+(1-\[Q2/(Q2 + Q4))\*(Q5/10 )\]}\*100.Activity Impairment=(Q6/10)\*100.Each WPAI domain is expressed as impairment percentages ranging from 0 to 100,with higher numbers indicating greater impairment \&less productivity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=184 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Absenteeism: Month 3	3.9 Percentage of impairment Standard Error 1.4
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Absenteeism: Month 6	1.7 Percentage of impairment Standard Error 1.6
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Absenteeism: Month 12	-0.08 Percentage of impairment Standard Error 1.5
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Presenteeism: Month 3	4.0 Percentage of impairment Standard Error 2.8
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Presenteeism: Month 6	4.2 Percentage of impairment Standard Error 3.6
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Presenteeism: Month 12	2.8 Percentage of impairment Standard Error 3.8
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Work Production Loss: Month 3	0.2 Percentage of impairment Standard Error 3.1
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Work Production Loss: Month 6	-1.9 Percentage of impairment Standard Error 3.7
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Work Production Loss: Month 12	-1.9 Percentage of impairment Standard Error 3.6
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Activity Impairment: Month 3	5.1 Percentage of impairment Standard Error 1.8
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Activity Impairment: Month 6	7.6 Percentage of impairment Standard Error 2.2
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 Change in Activity Impairment: Month 12	10.3 Percentage of impairment Standard Error 2.3

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. No imputation was applied for missing values in any visit. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

Participant's satisfaction with treatment was assessed on a 5-point scale (where 0 = very dissatisfied and 4 = very satisfied) in response to the question "How satisfied are you with the drugs you received for your arthritis during the last year?"

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Baseline: Very dissatisfied	13.6 Percentage of participants
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Baseline: Somewhat dissatisfied	34.3 Percentage of participants
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Baseline: Neither satisfied nor dissatisfied	31.8 Percentage of participants
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Baseline: Somewhat satisfied	17.7 Percentage of participants
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Baseline: Very satisfied	2.5 Percentage of participants
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Month 12: Very dissatisfied	2.0 Percentage of participants
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Month 12: Somewhat dissatisfied	4.7 Percentage of participants
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Month 12: Neither satisfied nor dissatisfied	16.7 Percentage of participants
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Month 12: Somewhat satisfied	46.0 Percentage of participants
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 Month 12: Very satisfied	30.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, "Number Analyzed" signifies number of participants evaluable with PtGA score at specified time points. No imputation was applied for missing values in any visit.

PtGA of Arthritis was measured using a VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity in response to the question "Considering all the way your arthritis affects you, how are you feeling today?".

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 Baseline	59.0 mm Standard Deviation 23.43
Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 Month 3	39.2 mm Standard Deviation 23.60
Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 Month 6	35.8 mm Standard Deviation 23.65
Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 Month 12	31.0 mm Standard Deviation 21.56

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

PhGA was measured using a VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity in response to how the physician assesses the participant's overall arthritis at the time of the visit. This is an evaluation based on the participant's disease signs, functional capacity and physical examination, and should be independent of the PtGA of arthritis.

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 Baseline	59.6 mm Standard Deviation 19.8
Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 Month 3	35.9 mm Standard Deviation 21.93
Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 Month 6	30.0 mm Standard Deviation 20.73
Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 Month 12	27.1 mm Standard Deviation 21.26

SECONDARY outcome

Timeframe: Up to 12 months

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements.

Number of participants who received tofacitinib as monotherapy,tofacitinib in combination therapy, tofacitinib switched from monotherapy to combination therapy, tofacitinib switched from combination therapy to monotherapy, tofacitinib in combination with disease modifying antirheumatic drugs (DMARD) then switched to tofacitinib monotherapy and tofacitinib in combination with DMARD then discontinued are presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants as Per Treatment Received Tofacitinib as Monotherapy	59 Participants
Number of Participants as Per Treatment Received Tofacitinib in Combination Therapy	113 Participants
Number of Participants as Per Treatment Received Tofacitinib Switched From Monotherapy to Combination Therapy	1 Participants
Number of Participants as Per Treatment Received Tofacitinib Switched From Combination Therapy to Monotherapy	5 Participants
Number of Participants as Per Treatment Received Tofacitinib in Combination with DMARD Then Switched to Tofacitinib Monotherapy	2 Participants
Number of Participants as Per Treatment Received Tofacitinib in Combination with DMARD Then Discontinued	18 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). The number of visits to a rheumatologist or other RA specialist since the last visit were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit Month 3	0.0 Visits Interval 0.0 to 5.0
Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit Month 6	0.0 Visits Interval 0.0 to 3.0
Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit Month 12	1.0 Visits Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants who underwent the diagnostic tests since last visit including: whole blood cell (WBC), ESR/CRP, glucose, hepatic enzymes, urea, creatinine, lipid profile (total cholesterol \[TC\], low density lipoprotein \[LDL\], high density lipoprotein \[HDL\], triglycerides \[TG\]), X-rays, others are presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants With Diagnostic Test Since Last Visit Month 3	76 Participants
Number of Participants With Diagnostic Test Since Last Visit Month 6	59 Participants
Number of Participants With Diagnostic Test Since Last Visit Month 12	50 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants who underwent the diagnostic tests including: WBC, ESR/CRP, glucose, hepatic enzymes, urea, creatinine, lipid profile (TC,LDL,HDL,TG), X-rays, others summarized by visit are presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants According to the Type of Diagnostic Test WBC- Month 3	69 Participants
Number of Participants According to the Type of Diagnostic Test WBC- Month 6	50 Participants
Number of Participants According to the Type of Diagnostic Test WBC- Month 12	42 Participants
Number of Participants According to the Type of Diagnostic Test ESR- Month 3	69 Participants
Number of Participants According to the Type of Diagnostic Test ESR- Month 6	55 Participants
Number of Participants According to the Type of Diagnostic Test ESR- Month 12	48 Participants
Number of Participants According to the Type of Diagnostic Test CRP- Month 3	67 Participants
Number of Participants According to the Type of Diagnostic Test CRP- Month 6	55 Participants
Number of Participants According to the Type of Diagnostic Test CRP- Month 12	47 Participants
Number of Participants According to the Type of Diagnostic Test Glucose- Month 3	56 Participants
Number of Participants According to the Type of Diagnostic Test Glucose- Month 6	44 Participants
Number of Participants According to the Type of Diagnostic Test Glucose- Month 12	39 Participants
Number of Participants According to the Type of Diagnostic Test Hepatic enzymes- Month 3	66 Participants
Number of Participants According to the Type of Diagnostic Test Hepatic enzymes- Month 6	49 Participants
Number of Participants According to the Type of Diagnostic Test Hepatic enzymes- Month 12	44 Participants
Number of Participants According to the Type of Diagnostic Test Urea- Month 3	62 Participants
Number of Participants According to the Type of Diagnostic Test Urea- Month 6	48 Participants
Number of Participants According to the Type of Diagnostic Test Urea- Month 12	44 Participants
Number of Participants According to the Type of Diagnostic Test Creatinine- Month 3	63 Participants
Number of Participants According to the Type of Diagnostic Test Creatinine- Month 6	50 Participants
Number of Participants According to the Type of Diagnostic Test Creatinine- Month 12	44 Participants
Number of Participants According to the Type of Diagnostic Test Lipid profile (TC, LDL, HDL, TG)- Month 3	29 Participants
Number of Participants According to the Type of Diagnostic Test Lipid profile (TC, LDL, HDL, TG)- Month 6	37 Participants
Number of Participants According to the Type of Diagnostic Test Lipid profile (TC, LDL, HDL, TG)- Month 12	29 Participants
Number of Participants According to the Type of Diagnostic Test X-rays- Month 3	1 Participants
Number of Participants According to the Type of Diagnostic Test X-rays- Month 6	4 Participants
Number of Participants According to the Type of Diagnostic Test X-rays- Month 12	3 Participants
Number of Participants According to the Type of Diagnostic Test Others- Month 3	13 Participants
Number of Participants According to the Type of Diagnostic Test Others- Month 6	8 Participants
Number of Participants According to the Type of Diagnostic Test Others- Month 12	4 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Diagnostic tests performed were as follow: WBC, ESR/CRP, glucose, hepatic enzymes, urea, creatinine, lipid profile (TC, LDL, HDL, TG), X-rays, others summarized by visit are presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Diagnostic Tests Since Last Visit Month 3	488 Diagnostic tests
Number of Diagnostic Tests Since Last Visit Month 6	292 Diagnostic tests
Number of Diagnostic Tests Since Last Visit Month 12	323 Diagnostic tests

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants hospitalized since their last visit were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=198 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants Hospitalized Since Last Visit Month 6	0 Participants
Number of Participants Hospitalized Since Last Visit Month 3	3 Participants
Number of Participants Hospitalized Since Last Visit Month 12	1 Participants

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants hospitalized in daycare and nightcare since their last visit were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=3 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants Hospitalized in Daycare and Night Care Since Last Visit Participants Hospitalized With Daycare: Month 3	0 Participants
Number of Participants Hospitalized in Daycare and Night Care Since Last Visit Participants Hospitalized With Daycare: Month 12	0 Participants
Number of Participants Hospitalized in Daycare and Night Care Since Last Visit Participants Hospitalized With Overnight Stay: Month 3	3 Participants
Number of Participants Hospitalized in Daycare and Night Care Since Last Visit Participants Hospitalized With Overnight Stay: Month 12	1 Participants

SECONDARY outcome

Timeframe: Baseline, Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable at specified time points.

The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Mean number of days participants were hospitalized since last visit were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=3 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Mean Number of Days Participants Were Hospitalized Since Last Visit Month 3	6.7 Days Standard Deviation 2.1

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. "Number of Participants analyzed" signifies number of participant evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable at specified time points.

The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants according to reason for hospitalization: polyarthritis, RA and pericarditis, RA flare, and right knee arthroplasty due to osteoarthritis since their last visit is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=3 Participants Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Number of Participants According to Reason for Hospitalization Since Last Visit Polyarthritis: Month 3	1 Participants
Number of Participants According to Reason for Hospitalization Since Last Visit Polyarthritis: Month 12	0 Participants
Number of Participants According to Reason for Hospitalization Since Last Visit RA and Pericarditis: Month 3	1 Participants
Number of Participants According to Reason for Hospitalization Since Last Visit RA and Pericarditis: Month 12	0 Participants
Number of Participants According to Reason for Hospitalization Since Last Visit RA flare: Month 3	1 Participants
Number of Participants According to Reason for Hospitalization Since Last Visit RA flare: Month 12	0 Participants
Number of Participants According to Reason for Hospitalization Since Last Visit Right knee arthroplasty due to Osteoarthritis: Month 3	0 Participants
Number of Participants According to Reason for Hospitalization Since Last Visit Right knee arthroplasty due to Osteoarthritis: Month 12	1 Participants

Adverse Events

Tofacitinib

Serious events: 24 serious events

Other events: 52 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Tofacitinib n=198 participants at risk Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Blood and lymphatic system disorders Abdominal lymphadenopathy	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Cardiac disorders Atrial fibrillation	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Cardiac disorders Cardiac arrest	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Gastrointestinal disorders Gastritis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
General disorders Condition aggravated	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
General disorders Drug ineffective	3.5% 7/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
General disorders Pyrexia	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Hepatobiliary disorders Haematotoxicity	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Hepatobiliary disorders Hepatotoxicity	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Immune system disorders Hypersensitivity	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Arthritis bacterial	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations COVID-19	1.0% 2/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Epiglottitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Herpes zoster	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Herpes zoster disseminated	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Lower Respiratory Tract infection	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Pasteurella infection	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Tooth abscess	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Upper respiratory tract infection	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Injury, poisoning and procedural complications Foot fracture	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Musculoskeletal and connective tissue disorders Polyarthritis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Renal and urinary disorders Chronic kidney disease	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Renal and urinary disorders Renal impairment	1.0% 2/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Vascular disorders Hypertension	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.

Other adverse events

Other adverse events
Measure	Tofacitinib n=198 participants at risk Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily.
Eye disorders Uveitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Gastrointestinal disorders Abdominal pain upper	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Gastrointestinal disorders Stomatitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Gastrointestinal disorders Abdominal discomfort	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Gastrointestinal disorders Gastric ulcer	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Gastrointestinal disorders Diarrhoea	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
General disorders Drug ineffective	6.6% 13/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
General disorders Fatigue	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
General disorders Oedema peripheral	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
General disorders Pyrexia	1.0% 2/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Hepatobiliary disorders Hypertransaminasaemia	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Hepatobiliary disorders Increased Aminotransferases	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Immune system disorders Hypersensitivity	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Bacterial pyelonephritis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Bronchitis	2.5% 5/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Bursitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations COVID-19	4.5% 9/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Cystitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Helicobacter infection	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Lower Respiratory Tract infection	1.0% 2/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Nasopharyngitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Periodontitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Pharyngitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Respiratory tract infection	1.0% 2/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Sinusitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Tooth abscess	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Upper respiratory tract infection	1.0% 2/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Infections and infestations Urinary tract infection	1.5% 3/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Injury, poisoning and procedural complications Ankle fracture	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Injury, poisoning and procedural complications Intentional product misuse	3.0% 6/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Injury, poisoning and procedural complications Product dose omission in error	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Injury, poisoning and procedural complications Product dose omission issue	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Investigations Blood creatine phosphokinase increased	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Investigations Transaminases increased	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Metabolism and nutrition disorders Dyslipidaemia	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Metabolism and nutrition disorders Hepatic steatosis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Musculoskeletal and connective tissue disorders Back pain	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Musculoskeletal and connective tissue disorders Greater trochanteric pain syndrome	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Musculoskeletal and connective tissue disorders Neck pain	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Nervous system disorders Carpal tunnel syndrome	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Nervous system disorders Headache	1.5% 3/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Psychiatric disorders Depression	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Renal and urinary disorders Haemoglobinuria	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Reproductive system and breast disorders Prostatitis	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Reproductive system and breast disorders Endometrial hyperplasia	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Skin and subcutaneous tissue disorders Alopecia areata	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Skin and subcutaneous tissue disorders Rash	1.0% 2/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.
Skin and subcutaneous tissue disorders Worsening of already existing skin lesions	0.51% 1/198 • 12 months Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. The safety analysis set included all participants who received at least one dose of tofacitinib.

Additional Information

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