Trial Outcomes & Findings for A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day (NCT NCT04267380)

NCT ID: NCT04267380

Last Updated: 2023-05-22

Results Overview

MCID improvement assessed based on Clinical disease activity index (CDAI). CDAI: numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 centimeter (cm) Visual analogue scale (VAS); CDAI total score = 0-76, higher scores=greater affection due to disease activity (DA). CDAI less than or equal to (\<=) 2.8 indicates disease remission, greater than (\>) 2.8 to 10 = low DA, \>10 to 22 = moderate DA, and \>22 = high DA. MCID improvement defined by difference in CDAI from baseline (at time of tofacitinib initiation) to 6 month visit. Participants were considered to show improvement from baseline on 3 cut points (1) greater than or equal (\>=) to 2 (for participants in low DA at baseline); (2) \>= 6 (moderate DA at baseline, and (3) \>= 11 (high DA at baseline). Here, overall number of participants who showed improvement have been reported.

• Recruitment status: COMPLETED
• Target enrollment: 298 participants
• Primary outcome timeframe: Baseline Up to 6 Months
• Results posted on: 2023-05-22

Participant Flow

The study was retrospective study of participants with rheumatoid arthritis (RA) who were tofacitinib initiators (first ever use of tofacitinib as reported by rheumatologist) on or after February 2016. Such participants were identified and their data was retrieved from United States (US) Corrona RA Registry database and assessed in this study.

Participant milestones

Measure	Tofacitinib Modified Release (MR) 11mg QD Participants with RA who initiated Tofacitinib 11 milligram (mg) MR tablet, orally, once daily (QD), 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.	Tofacitinib Immediate Release (IR) 5 mg BID Participants with RA who initiated Tofacitinib 5 mg IR tablet, orally, twice daily (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.
Overall Study STARTED	149	149
Overall Study COMPLETED	149	149
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day

Baseline characteristics by cohort

Measure	Tofacitinib Modified Release (MR) 11mg QD n=149 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.	Tofacitinib Immediate Release (IR) 5 mg BID n=149 Participants 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 n=298 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 12.0 • n=5 Participants	60.8 years STANDARD_DEVIATION 11.5 • n=7 Participants	60.0 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	117 Participants n=7 Participants	237 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	129 Participants n=5 Participants	130 Participants n=7 Participants	259 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline Up to 6 Months

Population: Analysis was performed on all participants included in the study.

MCID improvement assessed based on Clinical disease activity index (CDAI). CDAI: numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 centimeter (cm) Visual analogue scale (VAS); CDAI total score = 0-76, higher scores=greater affection due to disease activity (DA). CDAI less than or equal to (<=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 = low DA, >10 to 22 = moderate DA, and >22 = high DA. MCID improvement defined by difference in CDAI from baseline (at time of tofacitinib initiation) to 6 month visit. Participants were considered to show improvement from baseline on 3 cut points (1) greater than or equal (>=) to 2 (for participants in low DA at baseline); (2) >= 6 (moderate DA at baseline, and (3) >= 11 (high DA at baseline). Here, overall number of participants who showed improvement have been reported.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=149 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=149 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline Upto 6 Months	33 Participants	38 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: 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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=149 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=149 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 Baseline	17.9 units on a scale Standard Deviation 14.6	16.4 units on a scale Standard Deviation 12.2
Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 Change at Month 6	-2.12 units on a scale Standard Deviation 12.74	-2.19 units on a scale Standard Deviation 13.08

SECONDARY outcome

Timeframe: Month 6

Population: 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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=149 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=149 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants Achieving Remission at Month 6 (All Participants)	8 Participants	13 Participants

SECONDARY outcome

Timeframe: Month 6

Population: 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, only those participants who had baseline CDAI greater than 2.8, and who achieved remission (CDAI <= 2.8) at Month 6 have been reported.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=140 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=139 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants Achieving Remission at Month 6 (For Participants With Baseline CDAI >2.8)	4 Participants	8 Participants

SECONDARY outcome

Timeframe: Month 6

Population: 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 low disease activity (CDAI > 2.8 to 10) at Month 6 have been reported.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=149 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=149 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants Achieving Low Disease Activity at Month 6 (All Participants)	46 Participants	54 Participants

SECONDARY outcome

Timeframe: Month 6

Population: 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

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=94 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=96 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants Achieving Low Disease Activity at Month 6 (Participants With Baseline CDAI >10)	17 Participants	28 Participants

SECONDARY outcome

Timeframe: Month 6

Population: 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.

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=97 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=99 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants With Decrease From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6	26 Participants	24 Participants

SECONDARY outcome

Timeframe: Month 6

Population: 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.

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=124 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=122 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants With Decrease From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6	27 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: 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.

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=144 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=139 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Change From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6	-0.06 units on a scale Standard Deviation 0.38	-0.02 units on a scale Standard Deviation 0.41

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: 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.

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=133 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=130 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6	-0.07 units on a scale Standard Deviation 0.46	-0.03 units on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: 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.

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=144 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=139 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Change From Baseline in Modified Disease Activity Score Based on 28-joints Count (mDAS28) at Month 6 Baseline	4.2 units on a scale Standard Deviation 1.5	4.1 units on a scale Standard Deviation 1.4
Change From Baseline in Modified Disease Activity Score Based on 28-joints Count (mDAS28) at Month 6 Change at Month 6	-0.20 units on a scale Standard Deviation 1.34	-0.23 units on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: 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, 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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=71 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=68 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) Erythrocyte Sedimentation Rate (ESR) at Month 6 Baseline	4.0 units on a scale Standard Deviation 1.6	3.9 units on a scale Standard Deviation 1.6
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) Erythrocyte Sedimentation Rate (ESR) at Month 6 Change at Month 6	-0.10 units on a scale Standard Deviation 1.70	-0.17 units on a scale Standard Deviation 1.80

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: 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.

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=72 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=80 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) C- Reactive Protein (CRP) at 6 Month Baseline	3.9 units on a scale Standard Deviation 1.5	3.6 units on a scale Standard Deviation 1.4
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) C- Reactive Protein (CRP) at 6 Month Change at Month 6	-0.33 units on a scale Standard Deviation 1.56	-0.22 units on a scale Standard Deviation 1.57

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: Analysis was performed on all participants included in the study.

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=149 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=149 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Change From Baseline in Participant Pain Score at Month 6 Baseline	48.3 units on a scale Standard Deviation 27.4	48.2 units on a scale Standard Deviation 28.6
Change From Baseline in Participant Pain Score at Month 6 Change at Month 6	-0.78 units on a scale Standard Deviation 21.73	-1.30 units on a scale Standard Deviation 28.56

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: 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.

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=148 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=146 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Change From Baseline in Participant Fatigue Score at Month 6 Baseline	50.6 units on a scale Standard Deviation 29.9	48.6 units on a scale Standard Deviation 30.1
Change From Baseline in Participant Fatigue Score at Month 6 Change at Month 6	-0.86 units on a scale Standard Deviation 22.29	-0.04 units on a scale Standard Deviation 28.08

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: 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.

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.

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=122 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=126 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Change From Baseline in European Quality of Life- 5 Dimension (EQ-5D) Index at Month 6 Baseline	0.7 units on a scale Standard Deviation 0.2	0.7 units on a scale Standard Deviation 0.2
Change From Baseline in European Quality of Life- 5 Dimension (EQ-5D) Index at Month 6 Change at Month 6	0.00 units on a scale Standard Deviation 0.19	0.00 units on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: Month 6

Population: Analysis was performed on all participants included in the study.

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).

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=149 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=149 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response	23 Participants	14 Participants

SECONDARY outcome

Timeframe: Month 6

Population: 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).

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=149 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=149 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response	10 Participants	8 Participants

SECONDARY outcome

Timeframe: Month 6

Population: 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).

Outcome measures

Measure	Tofacitinib Immediate Release (IR) 5 mg BID n=149 Participants 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.	Tofacitinib Modified Release (MR) 11mg QD n=149 Participants Participants with RA who initiated Tofacitinib 11mg MR tablet, orally, QD, 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.
Number of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response	2 Participants	5 Participants

Adverse Events

Tofacitinib Modified Release (MR) 11mg QD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tofacitinib Immediate Release (IR) 5 mg BID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

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

Restriction type: OTHER