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. 2022 May 11;16(Suppl 2):ii30–ii41. doi: 10.1093/ecco-jcc/jjac011

Table 2.

Ustekinumab efficacy and safety data from real-life studies

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.