Serious infections occurred in less than 2% of patients treated with the medication during the duration of the 52-week trial.
Results from both an induction and maintenance therapy trial show ozanimod can be an effective treatment for patients with inflammatory bowel disease (IBD).
A team, led by William J. Sandborn, MD, University of California San Diego, compared ozanimod with placebo in achieving both clinical remission and clinical response in patients with moderate to severely active ulcerative colitis.
Ozanimod is a selective sphingosine-1-phosphate receptor modulator currently being studied for the treatment of patients with IBD.
In the phase 3, multicenter, randomized, double-blind, placebo-controlled trial, the investigators examined patients with moderately to severely active ulcerative colitis treated with ozanimod as an induction and maintenance therapy.
Patients in 1 group during the double-blind 10-week induction period received either the equivalent of 0.92 mg of ozanimod in oral ozanimod hydrochloride at a dose of 1 mg or placebo once daily. For patients in the second cohort, each patients received open-label ozanimod at the same daily dose.
After 10 weeks, patients who achieved a clinical response to the medication in either cohort were randomized to receive double-blind ozanimod or placebo for the maintenance period through week 52.
The investigators sought primary endpoints for both periods of the percentage of patients with clinical remission, which was assessed using the three-component Mayo score. They also looked at key secondary clinical, endoscopic, and histologic endpoints, which were evaluated with the use of ranked, hierarchical testing.
They also assessed safety.
There were 645 patients included in the first cohort during the induction period, compared to 367 in the second cohort. Clinical remission was significantly higher for the patients in the ozanimod arm compared to the placebo group during induction (18.4% vs. 6.0%; P <0.001). This was also true in the maintenance study (37.0% vs. 18.5% [among patients with a response at week 10]; P <0.001).
The same trends remained true for clinical response.
Clinical response was significantly higher in patients treated with ozanimod than it was with patients receiving placebo during both the induction period (47.8% vs. 25.9%; P <0.001) and maintenance (60.0% vs. 41.0%; P <0.001).
The investigators also found all of the predetermined secondary endpoints were significantly improved with ozanimod in both the induction and maintenance therapy periods.
In addition, the incidence of infection of any severity was similar in between ozanimod and placebo during the induction period. However, the incidence of infection was higher in patients treated with ozanimod than it was for the placebo group in the maintenance period.
For safety, serious infection occurred in less than 2% of patients in either group, while elevated liver aminotransferase levels were more common with ozanimod during the 52-week trial.
“Ozanimod was more effective than placebo as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis,” the authors wrote.
The study, “Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis,” was published online in The New England Journal of Medicine.