Efficacy and safety of ustekinumab in Russian bionaive patients with moderately to severely active ulcerative colitis: a subanalys is of global phase 3 induction and maintenance studies (UNIFI) up to 3 years

A IM : to evaluate efficacy and safety of ustekinumab in Russian patients with ulcerative colitis UNIFI study. PATIENTS AND METHODS: the program (CNTO1275UCO3001) consisted two randomized placebo-controlled trials: an 8-week induction study a 44-week maintenance long-term period. This analysis included from 14 centers. RESULTS enrolled 74 Russia, 89.2% (n = 66) were bionaive. The paper presents results bionaive patients. Sixty-six are phase: 18 received 130 mg IV, 25 6 mg/kg 23 placebo. At week 8 groups treated at doses mg, clinical remission was achieved 24.0% 16.7%, respectively, placebo group, rate 17.4%. proportion responses 68.0%, 50.0% 39.1% mg/kg, groups, respectively. Mucosal healing 48.0% 33.3% 21.7% group. Histoendoscopic mucosal developed 27.8% Forty re-randomized for further participation 13 90 subcutaneously every 12 weeks, 15 44, 46.2% 75.0% weeks (p 0.054 compared placebo), once group with. while percentage such 0.021 placebo) — 26.7%. Symptomatic 152 83.3% 81.8% In phase decrease CRP FCP median levels detected ustekinumab, phase, laboratory inflammatory markers after sustained by treatment. steroid-free symptomatic consistent remission. profile generally during all follow up CONCLUSION subanalysis confirmed shortand moderate severe active colitis. previously obtained data population participating global program.