Table 1.
Ustekinumab efficacy and safety data from randomised clinical trials
| First author | n of pts | Mean age [y] | Male n [%] | Study duration | Study arms | Primary endpoint | Main results | AEs | SAEs |
|---|---|---|---|---|---|---|---|---|---|
| Sandborn8 | 526 | 39.0 | 217 [41.3] | 36 weeks | iv UST 1 mg/kg iv UST 3 mg/kg iv UST 6 mg/kg PBO |
Clinical response at wk 6 | 36.6% 34.1% 39.7% 23.5% |
68.5% 66.2% 61.1% 71.2% |
4.6% 6.0% 6.9% 8.3% |
| Feagan9 | UNITI-1 741 UNITI-2 628 IM-UNITI 397 |
37.3 39.2 38.6 |
317 [42.8] 293 [46.7] 173 [43.6] |
8 weeks 8 weeks 44 weeks |
iv UST 130 mg; iv UST 6 mg/kg, PBO iv UST 130 mg; iv UST 6 mg/kg, PBO sc UST 90 mg e8w; sc UST 90 mg e12w, PBO |
Clinical response at wk 6 Clinical response at wk 6 Clinical remission at wk 44 |
34.3%, 33.7%, 21.5% 51.7%, 55.5%, 28.7% 53.1%, 48.8%, 35.9% |
64.6%, 65.9%, 64.9% 50.0%, 55.6%, 54.3% 81.7%, 80.3%, 83.5% |
4.9%, 7.2%, 6.1% 4.7%, 2.9%, 5.8% 9.9%, 12.1%, 15.0% |
| Sandborn10 | 237 | na | na | 252 weeks | sc UST 90 mg e8w sc UST 90 mg e12w |
Clinical remission at wk 252 | 34.4% 28.7% |
327.6 e100 py [cumulative UST] |
17.5 e100py [cumulativeUST] |
| Danese11 | 500 | na | na | 48 weeks | Treatment target arm Standard of care arm |
Endoscopic response at wk 48 | 33.6% 28.5% |
na | na |
n, number; pts, patients; y, years; AEs, adverse events; SAEs, serious adverse events; UST, ustekinumab; iv, intravenous; PBO, placebo; sc, subcutaneous; e8w, every 8 weeks; e12w,every 12 weeks; wk, week or Week; na, not available; e100py, events per 100 patient-years.