Tremfya OK'd for ulcerative colitis

FDA approved the IL-23 antagonist guselkumab (Tremfya) for the treatment of adults with moderately to severely active ulcerative colitis. Approval was based on results from the phase 2b/3 QUASAR study. In the induction phase, 23% of guselkumab recipients achieved clinical remission at 12 weeks vs. 8% with placebo. In the maintenance phase of the study, rates of clinical remission were 45% to 50% with guselkumab vs. 19% with placebo.