Table 1.
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.