Table 3.
Efficacy endpoints in the phase 3 program with tofacitinib.
| OCTAVE Induction 1 | OCTAVE Induction 2 | OCTAVE Sustain | |||||
|---|---|---|---|---|---|---|---|
| Placebo [n = 122] | 10 mg [n = 476] | Placebo [n = 112] | 10 mg [n = 429] | Placebo [n = 198] | 5 mg [n = 198] | 10 mg [n = 197] | |
| Clinical remission | 8.2% | 18.5% p = 0.007 |
3.6% | 16.6% p <0.001 |
11.1% | 34.3% p <0.001 |
40.6% p <0.001 |
| Clinical response | 32.8% | 59.9% p <0.001 |
28.6% | 55.0% p <0.001 |
20.2% | 51.5% p <0.001 |
61.9% p <0.001 |
| Mucosal healing | 15.6% | 31.3% p <0.001 |
11.6% | 28.4% p <0.001 |
13.1% | 37.4% p <0.001 |
45.7% p <0.001 |
| Endoscopic remission | 1.6% | 6.7% p = 0.04 |
1.8% | 7.0% p = 0.04 |
|||
| IBDQ remission | 37.7% | 52.5% p = 0.004 |
25.9% | 49.4% p <0.001 |
20.2% | 48.0% p <0.001 |
57.4% p <0.001 |
Clinical remission: total Mayo score of ≤2, with no individual sub-score >1 point and a rectal bleeding sub-score of 0 Clinical response: decrease from induction study baseline in Mayo score of ≥3 points and ≥30%, with an accompanying decrease in the rectal bleeding sub-score of ≥1 point or absolute rectal bleeding sub-score of 0 or 1. Mucosal healing: endoscopic sub-score of 0 or 1. Endoscopic remission: endoscopic sub-score of 0. IBDQ remission: an IBDQ score of ≥170.
IBDQ: Inflammatory Bowel Disease Questionnaire.