Ozanimod as induction therapy and maintenance therapy for ulcerative colitis
N Engl J Med 2021;385:1280–91 doi: 10.1056/NEJMoa2033617
Patients receiving ozanimod displayed a significant improvement in clinical response and all secondary endpoints during both the 10-week induction and 52-week maintenance study periods. Percentage of patients achieving clinical remission at Weeks 10 and 52 was the primary endpoint.
Ozanimod was well tolerated and presented a similar safety profile to patients receiving placebo and infection rate was higher in ozanimod patients during the maintenance period. Sandborn et al presented data from a Phase 3 randomised double-blind trial on the safety and efficacy of ozanimod as induction and maintenance therapy for patients with moderate to severe active UC. Patients were divided into two cohorts and randomised to receive either ozanimod 1 mg, or placebo.