Preliminary study too short and too small to establish clinical efficacy
WEDNESDAY, May 4, 2016 (HealthDay News) — A daily dose of ozanimod (1 mg) shows potentially positive results for clinical remission of ulcerative colitis, compared to placebo, according to a preliminary study published in the May 5 issue of the New England Journal of Medicine.
William J. Sandborn, M.D., from the University of California in San Diego, and colleagues conducted a double-blind, placebo-controlled phase 2 trial of ozanimod in 197 adults with moderate-to-severe ulcerative colitis. Patients were randomly assigned (1:1:1) to receive ozanimod at a dose of 0.5 mg, 1 mg, or placebo daily for up to 32 weeks.
The researchers found that clinical remission at eight weeks (primary outcome) occurred in 16 percent of the patients who received 1 mg of ozanimod and in 14 percent of those who received 0.5 mg of ozanimod, compared to 6 percent of those receiving placebo (P = 0.048 and 0.14, respectively, for the two doses versus placebo). The rate of clinical remission at week 32 was 21 percent in the 1-mg ozanimod group, 26 percent in the 0.5-mg ozanimod group, and 6 percent in the placebo group; the corresponding rates of clinical response (decrease in Mayo Clinic score of ≥3 points and ≥30 percent and decrease in rectal-bleeding subscore of ≥1 point or a subscore ≤1) were 51, 35, and 20 percent. Anemia and headache were the most common adverse events.
“The trial was not large enough or of sufficiently long duration to establish clinical efficacy or assess safety,” the authors write.
Several authors disclosed financial ties to Receptos, which funded the study and is now a wholly owned subsidiary of Celgene, the manufacturer of ozanimod.
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