Table 2.
Efficacy of UPA in U-ACHIEVE Phase 2 Trial
Primary and Secondary Endpoints at Week 8, N (%), p-value | UPA 7.5 mg, N = 47 | UPA 15 mg, N = 49 | UPA 30 mg, N = 52 | UPA 45 mg, N = 56 | PBO, N = 46 |
---|---|---|---|---|---|
Clinical remission | 4 (8.5), p = 0.052 | 7 (14.3), p = 0.013 | 7 (13.5), p = 0.011 | 11 (19.6), p = 0.002 | 0 (0) |
Endoscopic improvement | 7 (14.9), p = 0.033 | 15 (30.6), p < 0.001 | 14 (26.9), p < 0.001 | 20 (35.7), p < 0.001 | 1 (2.2) |
Clinical response | 14 (29.8), p = 0.046 | 22 (44.9), p < 0.001 | 23 (44.2), p < 0.001 | 28 (50), p < 0.001 | 6 (13) |
Endoscopic remission | 3 (6.4), p = 0.101 | 2 (4.1), p = 0.212 | 5 (9.6), p = 0.015 | 10 (17.9), p = 0.004 | 0 |
Histologic improvement | 15 (31.9), p = 0.003 | 25 (51), p < 0.001 | 23 (44.2), p < 0.001 | 27 (48.2), p < 0.001 | 3 (6.5) |
Abbreviations: UPA, upadacitinib; PBO, placebo.