Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy
Alimentary Pharmacology and Therapeutics Oct 26, 2020
Panaccione R, Danese S, Sandborn WJ, et al. - Whether subcutaneous ustekinumab can afford a good therapeutic choice for patients with moderate‐to‐severe ulcerative colitis (UC), from weeks 44 through 220, is investigated in the ongoing UNIFI long‐term extension. During the long‐term extension, efficacy (through week 92) as well as safety (through week 96) were evaluated. Participants were 399 patients who responded to intravenous ustekinumab induction and randomised to maintenance therapy. In the long‐term extension, 115 were administered subcutaneous placebo, 141 were given ustekinumab 90 mg every 12 weeks [q12w], and 143 were treated with ustekinumab 90 mg every 8 weeks [q8w]. Among all patients randomised in maintenance, the ustekinumab q12w and q8w groups showed symptomatic remission rates of 64.5% and 67.6%, respectively, at week 92. Findings demonstrated the sustained efficacy of ustekinumab through 92 weeks in patients with UC, and there were new safety signals.
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