Ozanimod beats placebo for ulcerative colitis – Consumer Health News
WEDNESDAY, September 29, 2021 (HealthDay News) – For patients with moderate to severe active ulcerative colitis, ozanimod is more effective than placebo as an induction and maintenance treatment, according to a study published in the issue of 30 September of the NOTew England Journal of Medicine.
William J. Sandborn, MD, of the University of California at San Diego in La Jolla, and colleagues conducted a randomized trial of ozanimod as induction and maintenance therapy in patients with moderate active ulcerative colitis to severe. During the 10-week induction period, patients in cohort 1 were randomized to receive oral ozanimod hydrochloride or placebo once daily (645 patients), and patients in cohort 2 received open-label ozanimod (367 patients). At 10 weeks, patients in either cohort with a clinical response to ozanimod were randomized to receive ozanimod or placebo during the maintenance period through week 52; 457 patients were included in this phase.
Researchers found that patients who received ozanimod had a significantly higher incidence of clinical remission compared to those who received placebo both during induction (18.4 versus 6.0 percent) and maintenance (37.0 versus 18.5 percent). [among those with a response at week 10]). Compared with placebo, a higher incidence of clinical response was observed with ozanimod during induction (47.8 versus 25.9 percent) and maintenance (60.0 versus 41.0 percent). Over both time periods, all other key secondary endpoints were significantly improved with ozanimod compared to placebo.
“A once daily oral formulation of ozanimod, a sphingosine-1-phosphate receptor modulator, has provided clinical efficacy in patients with moderately to severely active ulcerative colitis,” write the authors.
The study was funded by Bristol Myers Squibb, the maker of ozanimod.
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