Ozanimod Beats Placebo for Ulcerative Colitis
Once-daily oral ozanimod more effective than placebo for moderately to severely active ulcerative colitis
WEDNESDAY, Sept. 29, 2021 (HealthDay News) -- For patients with moderately to severely active ulcerative colitis, ozanimod is more effective than placebo as induction and maintenance therapy, according to a study published in the Sept. 30 issue of the New England Journal of Medicine.
William J. Sandborn, M.D., from the University of California San Diego in La Jolla, and colleagues conducted a randomized trial of ozanimod as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis. In the 10-week induction period, patients in cohort 1 were randomly assigned to oral ozanimod hydrochloride or placebo once daily (645 patients), and patients in cohort 2 received open-label ozanimod (367 patients). At 10 weeks, patients from either cohort with a clinical response to ozanimod underwent randomization to receive ozanimod or placebo for the maintenance period through week 52; 457 patients were included in this phase.
The researchers found that patients who received ozanimod had a significantly higher incidence of clinical remission compared with those who received placebo during both 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 seen with ozanimod during induction (47.8 versus 25.9 percent) and maintenance (60.0 versus 41.0 percent). In both periods, all other key secondary end points were significantly improved with ozanimod versus placebo.
"A once-daily oral formulation of ozanimod, a sphingosine-1-phosphate receptor modulator, provided clinical efficacy in patients with moderately to severely active ulcerative colitis," the authors write.
The study was funded by Bristol Myers Squibb, the manufacturer of ozanimod.