CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Here, all participants who achieved remission (CDAI <=2.8) at Month 6 have been reported.

CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Here, only those participants who had baseline CDAI greater than 2.8, and who achieved remission (CDAI <= 2.8) at Month 6 have been reported.

CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Here, all participants who achieved low disease activity (CDAI > 2.8 to 10) at Month 6 have been reported.

CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Here, only those participants who had baseline CDAI greater than 10, and who achieved low disease activity (CDAI > 2.8 to 10) at Month 6 have been reported.

Modified HAQ: participant-reported questionnaire for the assessment of ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Participants who had a baseline mHAQ score of >=0.25 were evaluable for this outcome measure and number of participants who had decrease from baseline in mHAQ score at Month 6 were reported.

HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis. It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week. Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Participants who had a baseline HAQ score of >=0.22 were evaluable for this outcome measure and number of participants who had decrease from baseline in HAQ score at Month 6 were reported.

Modified HAQ: participant-reported questionnaire for the assessment of ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions in 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week. Eight item were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.

HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis. It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week. Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.

Modified DAS28: Indicator of disease activity calculated as weighted average of six components: tender joint counts (TJC), swollen joint counts (SJC), mHAQ measure of disease activity, participant reported pain, physician reported global health assessment (PGA) and participant reported global health assessment (PtGA). TJC and SJC calculated using 28 joints count; mHAQ scored on a scale of 0 to 3 (0 = least difficulty, 3 = extreme difficulty); participant reported pain scored on a scale of 0 to 100 (0 = no pain, 100= pain as bad as it could be); PGA and PtGA recorded on a visual analog scale (VAS) of 0 millimeter (mm) to 100 mm (0 = no disease activity and 100=high disease activity). Transformed mDAS28 score ranged from 0 to 9.4, where higher scores indicated more disease activity.

DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and PtGA recorded on 100mm VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*PtGA [mm]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity.

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (milligrams per liter [mg/L]) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). DAS28 (CRP) was calculated as = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96.Total DAS28 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.

Participants were asked the following question to answer on a numeric rating scale (NRS): "How much pain have you had because of your arthritis in the past week?" The scale ranged from 0-100, where 0=no pain and 100=pain as bad as it could be. Higher scores indicated worsening of condition.

Participants were asked the following question to answer on NRS: "How much of a problem has unusual fatigue of tiredness been for you in the past week?" The scale ranged from 0-100, where 0=no fatigue and 100=fatigue as bad as it could be. Higher scores indicated worsening of condition.

EQ-5D index: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health in 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension had 3 levels: no problems (1), some problems (2) and severe problems (3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range 0 to 1, where 0=death and 1=perfect health; higher score indicates a better health state.

mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).

mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).

mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).

Participants with RA who initiated Tofacitinib 5 mg IR tablet, orally, BID, on or after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.

Total of all reporting groups

CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Here, all participants who achieved remission (CDAI <=2.8) at Month 6 have been reported.

Analysis was performed on all participants included in the study.

CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Here, all participants who achieved remission (CDAI <=2.8) at Month 6 have been reported.

Analysis was performed on all participants included in the study.

CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Here, only those participants who had baseline CDAI greater than 2.8, and who achieved remission (CDAI <= 2.8) at Month 6 have been reported.

Analysis was performed on only those participants who had baseline CDAI greater than 2.8. Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Here, all participants who achieved low disease activity (CDAI > 2.8 to 10) at Month 6 have been reported.

Analysis was performed on all participants included in the study.

CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Here, only those participants who had baseline CDAI greater than 10, and who achieved low disease activity (CDAI > 2.8 to 10) at Month 6 have been reported.

Analysis was performed on only those participants who had baseline CDAI greater than 10. Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure

Modified HAQ: participant-reported questionnaire for the assessment of ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Participants who had a baseline mHAQ score of >=0.25 were evaluable for this outcome measure and number of participants who had decrease from baseline in mHAQ score at Month 6 were reported.

Analysis was performed on participants who had a baseline mHAQ score of >=0.25. Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis. It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week. Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Participants who had a baseline HAQ score of >=0.22 were evaluable for this outcome measure and number of participants who had decrease from baseline in HAQ score at Month 6 were reported.

Analysis was performed on participants who had a baseline HAQ score of >=0.22. Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

Data for change from baseline in HAQ score as 'dichotomous variable' was not collected, as this outcome measure was inappropriately included in protocol specified secondary outcomes.

Modified HAQ: participant-reported questionnaire for the assessment of ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions in 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week. Eight item were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.

Analysis was performed on participants included in the study who were evaluable for mHAQ. Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis. It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week. Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.

Analysis was performed on participants included in the study who were evaluable for HAQ. Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

Modified DAS28: Indicator of disease activity calculated as weighted average of six components: tender joint counts (TJC), swollen joint counts (SJC), mHAQ measure of disease activity, participant reported pain, physician reported global health assessment (PGA) and participant reported global health assessment (PtGA). TJC and SJC calculated using 28 joints count; mHAQ scored on a scale of 0 to 3 (0 = least difficulty, 3 = extreme difficulty); participant reported pain scored on a scale of 0 to 100 (0 = no pain, 100= pain as bad as it could be); PGA and PtGA recorded on a visual analog scale (VAS) of 0 millimeter (mm) to 100 mm (0 = no disease activity and 100=high disease activity). Transformed mDAS28 score ranged from 0 to 9.4, where higher scores indicated more disease activity.

Analysis was performed on participants included in the study who were evaluable for mDAS28. Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and PtGA recorded on 100mm VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 (ESR) was calculated as 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.70*ln(ESR [mm/hour] + 0.014*PtGA [mm]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity.

Analysis was performed on participants included in the study who were evaluable for DAS28 (ESR). Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (milligrams per liter [mg/L]) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). DAS28 (CRP) was calculated as = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96.Total DAS28 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.

Analysis was performed on participants included in the study who were evaluable for DAS28 (CRP). Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

Participants were asked the following question to answer on a numeric rating scale (NRS): "How much pain have you had because of your arthritis in the past week?" The scale ranged from 0-100, where 0=no pain and 100=pain as bad as it could be. Higher scores indicated worsening of condition.

Analysis was performed on all participants included in the study.

Participants were asked the following question to answer on NRS: "How much of a problem has unusual fatigue of tiredness been for you in the past week?" The scale ranged from 0-100, where 0=no fatigue and 100=fatigue as bad as it could be. Higher scores indicated worsening of condition.

Analysis was performed on participants included in the study who were evaluable for fatigue score. Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

EQ-5D index: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health in 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension had 3 levels: no problems (1), some problems (2) and severe problems (3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range 0 to 1, where 0=death and 1=perfect health; higher score indicates a better health state.

Analysis was performed on participants included in the study who were evaluable for EQ-5D score. Hence, "Overall Number of Participants Analyzed" signifies only those participants who were evaluable for this outcome measure.

mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).

Analysis was performed on all participants included in the study.

mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).

Analysis was performed on all participants included in the study.

mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).

Analysis was performed on all participants included in the study.

Participants with RA who initiated Tofacitinib 5 mg IR tablet, orally, BID, on or after February 2016 and followed up for 6 months after tofacitinib initiation were included in this study. Their information as per US Corrona RA Registry database for approximately 3.7 years from February 2016 to end of September 2019 was assessed in this study. Baseline in the study is defined as the time of tofacitinib initiation.