| PBO (n = 209) | UST 130 mg (n = 209) | UST ~6 mg/kgcc (n = 209) | |
|---|---|---|---|
| Clinical Responsea | |||
| Wk 3 | 45 (21.5) | 68 (32.5) p = 0.010 | 81 (38.8) p < 0.001 |
| *Wk 6 | 60 (28.7) |
108 (51.7) Delta =23% p < 0.001 |
116 (55.5) Delta =26.8% p < 0.001 |
| Wk 8 | 67 (32.1) | 99 (47.4) p < 0.001 | 121 (57.9) p < 0.001 |
| Clinical Remissionb | |||
| Wk 3 | 24 (11.5) | 33 (15.8) p = 0.199 | 48 (23.0) p = 0.002 |
| Wk 6 | 37 (17.7) | 60 (28.7) p = 0.007 | 73 (34.9) p < 0.001 |
| Wk 8 | 41 (19.6) | 64 (30.6) Delta =11.0% p = 0.009 | 84 (40.2) Delta =20.6% p < 0.001 |
↵N (%); a ≥ 100 pt reduction in CDAI; bCDAI <150; cweight-range based UST doses ~6 mg/kg: 260 mg (weight ≤55 kg), 390 mg (weight >55 kg and ≤85 kg), 520 mg (weight >85 kg); *primary endpoint