Table 2.
Efficacy endpoints in the phase 2 trial with tofacitinib.
| Placebo [n = 48] | Tofacitinib | ||||
|---|---|---|---|---|---|
| 0.5 mg [n = 31] | 3 mg [n = 33] | 10 mg [n = 33] | 15 mg [n = 49] | ||
| Clinical response | 42% | 32% p = 0.39 |
48% p = 0.55 |
61% p = 0.10 |
78% p <0.001 |
| Clinical remission | 10% | 13% p = 0.76 |
33% p = 0.01 |
48% p <0.001 |
41% p <0.001 |
| Endoscopic response | 46% | 52% p = 0.64 |
58% p = 0.30 |
67% p = 0.07 |
78% p = 0.001 |
| Endoscopic remission | 2% | 10% p = 0.14 |
18% p = 0.01 |
30% p <0.001 |
27% p <0.001 |
| Mean [±SD] change in IBDQ from baseline | 27.8 [±29.8] | 27.7 [±33.4] p = 0.94 |
30.3 [±27.3] p = 0.28 |
30.4 [±39.8] p = 0.16 |
50.7 [±35.6] p <0.001 |
Clinical response: decrease in the total Mayo score with ≥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. Clinical remission: total Mayo score of ≤2, with no individual sub-score >1 point. Endoscopic response: a decrease in the endoscopy sub-score with ≥1. Endoscopic remission: endoscopic sub-score of 0.
IBDQ: Inflammatory Bowel Disease Questionnaire; SD: standard deviation.