Ulcerative Colitis
Conditions
Keywords
Janus kinase inhibitor, JAK 3 inhibitor, inflammatory bowel disease, ulcerative colitis, OCTAVE, CP-690, 550, tofacitinib, Xeljanz
Brief summary
The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.
Interventions
DRUGPlacebo
Placebo 10 mg orally (PO) twice a day (BID)
DRUGCP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)
DRUGCP-690,550
CP-690,550 10 mg orally (PO) twice a day (BID)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095 * Subjects who achieved clinical response in Study A3921094 or A3921095 * Women of childbearing potential must test negative for pregnancy prior to study enrollment * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures * Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
* Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095 * Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease * Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants In Remission at Week 52 | Week 52 | Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline | Week 24, 52 | Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure. |
| Percentage of Participants in Remission at Week 24 | Week 24 | Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. |
| Percentage of Participants in Sustained Remission | Week 24, 52 | Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity. |
| Percentage of Participants With Mucosal Healing at Week 24 | Week 24 | Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity. |
| Percentage of Participants With Sustained Mucosal Healing | Week 24, 52 | Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity. |
| Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline | Week 24, 52 | Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity. |
| Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline | Week 24, 52 | Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity. |
| Percentage of Participants With Clinical Response at Week 24 and 52 | Week 24, 52 | Clinical response was defined by a decrease from induction study (A3921094 \[NCT01465763\] or A3921095 \[NCT01458951\]) baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure. |
| Percentage of Participants With Sustained Clinical Response | Week 24, 52 | Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 \[NCT01465763\] or A3921095 \[NCT01458951\]) baseline in mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure. |
| Percentage of Participants in Clinical Remission at Week 24 and 52 | Week 24, 52 | Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. |
| Percentage of Participants in Sustained Clinical Remission | Week 24, 52 | Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. |
| Percentage of Participants in Deep Remission at Week 24 and 52 | Week 24, 52 | Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. |
| Percentage of Participants With Mucosal Healing at Week 52 | Week 52 | Mucosal healing in participants was defined by mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity. |
| Percentage of Participants in Symptomatic Remission at Week 24 and 52 | Week 24, 52 | Symptomatic remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. |
| Percentage of Participants in Sustained Symptomatic Remission | Week 24, 52 | Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. |
| Percentage of Participants in Endoscopic Remission at Week 24 and 52 | Week 24, 52 | Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity. |
| Percentage of Participants in Sustained Endoscopic Remission | Week 24, 52 | Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity. |
| Total Mayo Score at Baseline, Week 24 and 52 | Baseline, Week 24, 52 | Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. |
| Change From Baseline in Total Mayo Score at Week 24 and 52 | Baseline, Week 24, 52 | Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported. |
| Percentage of Participants in Remission, Among Participants With Remission at Baseline | Week 24, 52 | Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity. |
| Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline | Week 24, 52 | Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity. |
| Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline | Week 24, 52 | Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure. |
| Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | Week 24, 52 | Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure. |
| Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | Week 24, 52 | Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure. |
| Percentage of Participants in Sustained Deep Remission | Week 24, 52 | Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. |
Countries
Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib 5 mg BID Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | 198 |
| Tofacitinib 10 mg BID Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | 197 |
| Placebo Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | 198 |
| Total | 593 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 9 | 7 |
| Overall Study | Lack of Efficacy | 70 | 53 | 132 |
| Overall Study | Lost to Follow-up | 3 | 2 | 1 |
| Overall Study | Other | 2 | 1 | 0 |
| Overall Study | Pregnancy | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Randomized but not treated | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 3 | 5 |
Baseline characteristics
| Characteristic | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 13.7 | 42.9 years STANDARD_DEVIATION 14.4 | 43.4 years STANDARD_DEVIATION 14 | 42.7 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 95 Participants | 87 Participants | 82 Participants | 264 Participants |
| Sex: Female, Male Male | 103 Participants | 110 Participants | 116 Participants | 329 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 87 / 198 | 107 / 196 | 108 / 198 |
| serious Total, serious adverse events | 10 / 198 | 11 / 196 | 13 / 198 |
Outcome results
Primary
Percentage of Participants In Remission at Week 52
Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.
Time frame: Week 52
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants In Remission at Week 52 | 34.3 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants In Remission at Week 52 | 40.6 percentage of participants |
| Placebo | Percentage of Participants In Remission at Week 52 | 11.1 percentage of participants |
Comparison: P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95 percent (%) confidence interval (CI) based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).p-value: <0.000195% CI: [15.3, 31.2]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [21.4, 37.6]CMH chi-square test
Secondary
Change From Baseline in Total Mayo Score at Week 24 and 52
Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported.
Time frame: Baseline, Week 24, 52
Population: FAS included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Total Mayo Score at Week 24 and 52 | Change at Week 24 (n = 179, 186, 181) | 0.3 units on a scale | Standard Error 0.3 |
| Tofacitinib 5 mg BID | Change From Baseline in Total Mayo Score at Week 24 and 52 | Change at Week 52 (n = 129, 137, 68) | 0.4 units on a scale | Standard Error 0.3 |
| Tofacitinib 10 mg BID | Change From Baseline in Total Mayo Score at Week 24 and 52 | Change at Week 24 (n = 179, 186, 181) | 0.0 units on a scale | Standard Error 0.3 |
| Tofacitinib 10 mg BID | Change From Baseline in Total Mayo Score at Week 24 and 52 | Change at Week 52 (n = 129, 137, 68) | -0.4 units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in Total Mayo Score at Week 24 and 52 | Change at Week 24 (n = 179, 186, 181) | 2.9 units on a scale | Standard Error 0.3 |
| Placebo | Change From Baseline in Total Mayo Score at Week 24 and 52 | Change at Week 52 (n = 129, 137, 68) | 2.9 units on a scale | Standard Error 0.4 |
Comparison: At Week 24p-value: <0.000195% CI: [-3.2, -1.9]Linear mixed effect model
Comparison: At Week 24p-value: <0.000195% CI: [-3.5, -2.2]Linear mixed effect model
Comparison: At Week 52p-value: <0.000195% CI: [-3.4, -1.7]Linear mixed effect model
Comparison: At Week 52p-value: <0.000195% CI: [-4.1, -2.5]Linear mixed effect model
Secondary
Percentage of Participants in Clinical Remission at Week 24 and 52
Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Clinical Remission at Week 24 and 52 | Week 24 | 34.3 percentage of participants |
| Tofacitinib 5 mg BID | Percentage of Participants in Clinical Remission at Week 24 and 52 | Week 52 | 34.3 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Clinical Remission at Week 24 and 52 | Week 24 | 35.5 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Clinical Remission at Week 24 and 52 | Week 52 | 41.1 percentage of participants |
| Placebo | Percentage of Participants in Clinical Remission at Week 24 and 52 | Week 24 | 11.1 percentage of participants |
| Placebo | Percentage of Participants in Clinical Remission at Week 24 and 52 | Week 52 | 11.1 percentage of participants |
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [15.3, 31.2]CMH chi-square test
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [16.4, 32.4]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [15.3, 31.2]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [21.9, 38.2]CMH chi-square test
Secondary
Percentage of Participants in Deep Remission at Week 24 and 52
Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Deep Remission at Week 24 and 52 | Week 24 | 14.1 percentage of participants |
| Tofacitinib 5 mg BID | Percentage of Participants in Deep Remission at Week 24 and 52 | Week 52 | 14.6 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Deep Remission at Week 24 and 52 | Week 24 | 10.7 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Deep Remission at Week 24 and 52 | Week 52 | 15.2 percentage of participants |
| Placebo | Percentage of Participants in Deep Remission at Week 24 and 52 | Week 24 | 4.0 percentage of participants |
| Placebo | Percentage of Participants in Deep Remission at Week 24 and 52 | Week 52 | 4.0 percentage of participants |
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.000695% CI: [4.5, 15.7]CMH chi-square test
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.009295% CI: [1.5, 11.7]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.000495% CI: [5, 16.2]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [5.5, 16.9]CMH chi-square test
Secondary
Percentage of Participants in Endoscopic Remission at Week 24 and 52
Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Endoscopic Remission at Week 24 and 52 | Week 24 | 16.2 percentage of participants |
| Tofacitinib 5 mg BID | Percentage of Participants in Endoscopic Remission at Week 24 and 52 | Week 52 | 14.6 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Endoscopic Remission at Week 24 and 52 | Week 24 | 12.2 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Endoscopic Remission at Week 24 and 52 | Week 52 | 16.8 percentage of participants |
| Placebo | Percentage of Participants in Endoscopic Remission at Week 24 and 52 | Week 24 | 4.0 percentage of participants |
| Placebo | Percentage of Participants in Endoscopic Remission at Week 24 and 52 | Week 52 | 4.0 percentage of participants |
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [6.3, 17.9]CMH chi-square test
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.002195% CI: [2.8, 13.5]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.000495% CI: [5, 16.2]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [6.8, 18.6]CMH chi-square test
Secondary
Percentage of Participants in Remission, Among Participants With Remission at Baseline
Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Remission, Among Participants With Remission at Baseline | Week 52 | 46.2 percentage of participants |
| Tofacitinib 5 mg BID | Percentage of Participants in Remission, Among Participants With Remission at Baseline | Week 24 | 55.4 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Remission, Among Participants With Remission at Baseline | Week 24 | 63.6 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Remission, Among Participants With Remission at Baseline | Week 52 | 56.4 percentage of participants |
| Placebo | Percentage of Participants in Remission, Among Participants With Remission at Baseline | Week 24 | 15.3 percentage of participants |
| Placebo | Percentage of Participants in Remission, Among Participants With Remission at Baseline | Week 52 | 10.2 percentage of participants |
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [25, 55.3]CMH chi-square test
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [32.7, 64.1]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [21.6, 50.3]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [31, 61.4]CMH chi-square test
Secondary
Percentage of Participants in Remission at Week 24
Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time frame: Week 24
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Remission at Week 24 | 33.8 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Remission at Week 24 | 35.5 percentage of participants |
| Placebo | Percentage of Participants in Remission at Week 24 | 11.1 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [14.8, 30.6]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [16.4, 32.4]CMH chi-square test
Secondary
Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline
Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure.
Time frame: Week 24, 52
Population: FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline | Week 24 | 53.8 percentage of participants |
| Tofacitinib 5 mg BID | Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline | Week 52 | 44.6 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline | Week 24 | 63.6 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline | Week 52 | 56.4 percentage of participants |
| Placebo | Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline | Week 24 | 15.3 percentage of participants |
| Placebo | Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline | Week 52 | 10.2 percentage of participants |
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [23.4, 53.8]CMH chi-square test
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [32.7, 64.1]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [20.1, 48.8]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [31, 61.4]CMH chi-square test
Secondary
Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure.
Time frame: Week 24, 52
Population: FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | Week 24 | 23.8 percentage of participants |
| Tofacitinib 5 mg BID | Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | Week 52 | 27.7 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | Week 24 | 24.1 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | Week 52 | 27.6 percentage of participants |
| Placebo | Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | Week 24 | 10.9 percentage of participants |
| Placebo | Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | Week 52 | 10.9 percentage of participants |
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.007495% CI: [2.6, 23.2]CMH chi-square test
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.010395% CI: [2.4, 24.1]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.001895% CI: [6.2, 27.5]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.002995% CI: [5.5, 27.9]CMH chi-square test
Secondary
Percentage of Participants in Sustained Clinical Remission
Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Sustained Clinical Remission | 22.2 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Sustained Clinical Remission | 25.9 percentage of participants |
| Placebo | Percentage of Participants in Sustained Clinical Remission | 5.1 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [10.6, 23.7]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [14, 27.7]CMH chi-square test
Secondary
Percentage of Participants in Sustained Deep Remission
Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Sustained Deep Remission | 6.1 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Sustained Deep Remission | 3.6 percentage of participants |
| Placebo | Percentage of Participants in Sustained Deep Remission | 0.5 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.002995% CI: [2.1, 9]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.03595% CI: [0.3, 5.8]CMH chi-square test
Secondary
Percentage of Participants in Sustained Endoscopic Remission
Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Sustained Endoscopic Remission | 6.1 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Sustained Endoscopic Remission | 5.1 percentage of participants |
| Placebo | Percentage of Participants in Sustained Endoscopic Remission | 0.5 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.002995% CI: [2.1, 9]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.006495% CI: [1.4, 7.8]CMH chi-square test
Secondary
Percentage of Participants in Sustained Remission
Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Sustained Remission | 22.2 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Sustained Remission | 25.4 percentage of participants |
| Placebo | Percentage of Participants in Sustained Remission | 5.1 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [10.6, 23.7]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [13.5, 27.1]CMH chi-square test
Secondary
Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline
Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline | 36.9 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline | 47.3 percentage of participants |
| Placebo | Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline | 5.1 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [18.8, 44.8]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [27.9, 56.5]CMH chi-square test
Secondary
Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure.
Time frame: Week 24, 52
Population: FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | 12.9 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | 16.1 percentage of participants |
| Placebo | Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline | 5.0 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.041995% CI: [0.1, 15.7]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: 0.012195% CI: [2.3, 19.9]CMH chi-square test
Secondary
Percentage of Participants in Sustained Symptomatic Remission
Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Sustained Symptomatic Remission | 13.6 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Sustained Symptomatic Remission | 15.7 percentage of participants |
| Placebo | Percentage of Participants in Sustained Symptomatic Remission | 2.5 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [5.9, 16.4]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [7.7, 18.7]CMH chi-square test
Secondary
Percentage of Participants in Symptomatic Remission at Week 24 and 52
Symptomatic remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants in Symptomatic Remission at Week 24 and 52 | Week 24 | 23.7 percentage of participants |
| Tofacitinib 5 mg BID | Percentage of Participants in Symptomatic Remission at Week 24 and 52 | Week 52 | 22.7 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Symptomatic Remission at Week 24 and 52 | Week 24 | 21.8 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants in Symptomatic Remission at Week 24 and 52 | Week 52 | 26.9 percentage of participants |
| Placebo | Percentage of Participants in Symptomatic Remission at Week 24 and 52 | Week 24 | 6.6 percentage of participants |
| Placebo | Percentage of Participants in Symptomatic Remission at Week 24 and 52 | Week 52 | 7.1 percentage of participants |
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [10.3, 24]CMH chi-square test
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [8.5, 22]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [8.8, 22.5]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [12.7, 27]CMH chi-square test
Secondary
Percentage of Participants With Clinical Response at Week 24 and 52
Clinical response was defined by a decrease from induction study (A3921094 \[NCT01465763\] or A3921095 \[NCT01458951\]) baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants With Clinical Response at Week 24 and 52 | Week 24 | 63.6 percentage of participants |
| Tofacitinib 5 mg BID | Percentage of Participants With Clinical Response at Week 24 and 52 | Week 52 | 51.5 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Clinical Response at Week 24 and 52 | Week 24 | 70.6 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Clinical Response at Week 24 and 52 | Week 52 | 61.9 percentage of participants |
| Placebo | Percentage of Participants With Clinical Response at Week 24 and 52 | Week 24 | 33.3 percentage of participants |
| Placebo | Percentage of Participants With Clinical Response at Week 24 and 52 | Week 52 | 20.2 percentage of participants |
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [20.9, 39.7]CMH chi-square test
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [28.1, 46.4]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [22.4, 40.2]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [32.9, 50.5]CMH chi-square test
Secondary
Percentage of Participants With Mucosal Healing at Week 24
Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Time frame: Week 24
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants With Mucosal Healing at Week 24 | 43.9 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Mucosal Healing at Week 24 | 46.2 percentage of participants |
| Placebo | Percentage of Participants With Mucosal Healing at Week 24 | 17.2 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [18.1, 35.5]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [20.3, 37.7]CMH chi-square test
Secondary
Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline
Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline | Week 24 | 52.4 percentage of participants |
| Tofacitinib 5 mg BID | Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline | Week 52 | 41.9 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline | Week 24 | 66.3 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline | Week 52 | 55.1 percentage of participants |
| Placebo | Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline | Week 24 | 21.8 percentage of participants |
| Placebo | Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline | Week 52 | 11.9 percentage of participants |
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [18.1, 43.1]CMH chi-square test
Comparison: At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [31.8, 57.2]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [18.7, 41.4]CMH chi-square test
Comparison: At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [31.1, 55.3]CMH chi-square test
Secondary
Percentage of Participants With Mucosal Healing at Week 52
Mucosal healing in participants was defined by mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Time frame: Week 52
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants With Mucosal Healing at Week 52 | 37.4 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Mucosal Healing at Week 52 | 45.7 percentage of participants |
| Placebo | Percentage of Participants With Mucosal Healing at Week 52 | 13.1 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [16, 32.5]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [24.2, 41]CMH chi-square test
Secondary
Percentage of Participants With Sustained Clinical Response
Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 \[NCT01465763\] or A3921095 \[NCT01458951\]) baseline in mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants With Sustained Clinical Response | 49.0 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Sustained Clinical Response | 59.4 percentage of participants |
| Placebo | Percentage of Participants With Sustained Clinical Response | 19.2 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [20.9, 38.7]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [31.4, 49]CMH chi-square test
Secondary
Percentage of Participants With Sustained Mucosal Healing
Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants With Sustained Mucosal Healing | 27.8 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Sustained Mucosal Healing | 33.0 percentage of participants |
| Placebo | Percentage of Participants With Sustained Mucosal Healing | 6.6 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [14.1, 28.3]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [19, 33.8]CMH chi-square test
Secondary
Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline
Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Time frame: Week 24, 52
Population: FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline | 33.3 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline | 49.4 percentage of participants |
| Placebo | Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline | 8.9 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [13.8, 35]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [28.7, 52.3]CMH chi-square test
Secondary
Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline
Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure.
Time frame: Week 24, 52
Population: FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline | 35.4 percentage of participants |
| Tofacitinib 10 mg BID | Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline | 47.3 percentage of participants |
| Placebo | Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline | 5.1 percentage of participants |
Comparison: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [17.4, 43.2]CMH chi-square test
Comparison: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.p-value: <0.000195% CI: [27.9, 56.5]CMH chi-square test
Secondary
Total Mayo Score at Baseline, Week 24 and 52
Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Time frame: Baseline, Week 24, 52
Population: FAS included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Total Mayo Score at Baseline, Week 24 and 52 | Week 24 (n = 179, 186, 181) | 4.1 units on a scale | Standard Deviation 3.4 |
| Tofacitinib 5 mg BID | Total Mayo Score at Baseline, Week 24 and 52 | Baseline (n = 198, 197, 198) | 3.3 units on a scale | Standard Deviation 1.8 |
| Tofacitinib 5 mg BID | Total Mayo Score at Baseline, Week 24 and 52 | Week 52 (n = 129, 137, 68) | 3.2 units on a scale | Standard Deviation 3.1 |
| Tofacitinib 10 mg BID | Total Mayo Score at Baseline, Week 24 and 52 | Week 24 (n = 179, 186, 181) | 4.0 units on a scale | Standard Deviation 3.3 |
| Tofacitinib 10 mg BID | Total Mayo Score at Baseline, Week 24 and 52 | Baseline (n = 198, 197, 198) | 3.4 units on a scale | Standard Deviation 1.8 |
| Tofacitinib 10 mg BID | Total Mayo Score at Baseline, Week 24 and 52 | Week 52 (n = 129, 137, 68) | 2.6 units on a scale | Standard Deviation 2.7 |
| Placebo | Total Mayo Score at Baseline, Week 24 and 52 | Baseline (n = 198, 197, 198) | 3.3 units on a scale | Standard Deviation 1.8 |
| Placebo | Total Mayo Score at Baseline, Week 24 and 52 | Week 52 (n = 129, 137, 68) | 4.6 units on a scale | Standard Deviation 3.2 |
| Placebo | Total Mayo Score at Baseline, Week 24 and 52 | Week 24 (n = 179, 186, 181) | 6.7 units on a scale | Standard Deviation 3.5 |