Table 2.
First author | n of pts | Mean age [y] | Male n [%] | Study duration | Study arms | Primary endpoint | Main results | AEs | SAEs |
---|---|---|---|---|---|---|---|---|---|
Chaparro12 | 463 | 45 | na | 15 months | sc UST 90 mg e8w sc UST 90 mg e12w |
Clinical remission at wk 16 | 56.0% [cumulative UST] | na | na |
Straatmijer13 | 252 | 41 | 100 [39.7%] | 104 weeks | sc UST 90 mg e8w sc UST 90 mg e12w |
Corticosteroid-free clinical remission at wk 104 | 34.0% [cumulative UST] | 99 e100py [cumulative UST] |
9 e100py [cumulative UST] |
Iborra14 | 407 | 45.3 | 195 [48.0%] | 52 weeks | sc UST 90 mg e4w sc UST 90 mg e8w sc UST 90 mg e12w |
Clinical remission at wk 52 | 60.0% 72.0% 89.0% |
14.7% [cumulative UST] | na |
Bermejo15 | 53 | 45 | 26 [49.1%] | 16 weeks | sc UST 90 mg e4w sc UST 90 mg e8w sc UST 90 mg e12w |
Clinical remission at wk 16 | 43.3% [cumulative UST] | na | 1.9% |
Fumery16 | 100 | 35 | 48 [48.0%] | 8.2 months | sc UST 90 mg e4w | Corticosteroid-free clinical remission at 6 months | 49.0% | 12.0% | 5.0% |
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.