Loading...
Ustekinumab is FDA approved to treat Crohn disease, but to date, no controlled trial data have been reported on its efficacy for ulcerative colitis. Now, findings are available from an industry-funded, phase III, placebo-controlled induction and maintenance study conducted for 3 years at 244 sites worldwide.
In an 8-week induction phase, 961 patients with moderate-to-severe ulcerative colitis were randomized to intravenous ustekinumab or placebo; those with no response to placebo at week 8 received one induction dose of ustekinumab. In a 44-week maintenance phase, 523 responders to ustekinumab were randomized to receive subcutaneous ustekinumab every 8 or 12 weeks or placebo.
At week 8, the clinical remission rate was significantly higher wit…