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. 2020 May 5;13:131–139. doi: 10.2147/CEG.S208020

Table 1.

Main Results from Phase 3 Studies (OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain) Evaluating Tofacitinib in Moderate-to-Severe Ulcerative Colitis (Ref 36). For Induction Trials, Endpoints Were Evaluated at 8 Weeks; for Sustain Trial, Endpoints Were Evaluated at 52 Weeks

OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain
Placebo N=122 10 mg N=476 P value Placebo N=112 10 mg N=429 P value Placebo N=198 5 mg N=198 P value 10 mg N=197 P value
Primary endpoint
 Clinical remission 10 (8.2%) 88 (18.5%) 0.007 4 (3.6%) 71 (16.6%) <0.001 22 (11.1%) 68 (34.3%) <0.001 80 (40.6%) <0.001
Secondary endpoint
 Mucosal healing 19 (15.6%) 149 (31.3%) <0.001 13 (11.6%) 122 (28.4%) <0.001 26 (13.1%) 74 (37.4%) <0.001 90 (45.7%) <0.001
 Clinical response 40 (32.8%) 285 (59.9%) <0.001 32 (28.6%) 236 (55%) <0.001 40 (20.2%) 102 (51.5%) <0.001 122 (61.9%) <0.001
 IBDQ remission 46 (37.7%) 250 (52.5%) 0.004 29 (25.9%) 212 (49.4%) <0.001 40 (20.2%) 95 (48%) <0.001 113 (57.4%) <0.001

Abbreviation: IBDQ, Inflammatory Bowel Disease Questionnaire.