Stelara for UC shows positive phase 3 UNIFI study results

J&J’s Phase 3 UNIFI study assessed the safety and efficacy of Stelara (ustekinumab), a human IL-12 and IL-23 antagonist, to treat moderate to severe ulcerative colitis in adults who showed an inadequate response to, or were unable to tolerate, conventional or biologic therapies. The study showed that for both doses administered, Stelara induced clinical remission in a significantly larger number of ulcerative colitis patients by the eighth week versus placebo. The number of patients in clinical response, endoscopic healing and improvement in health-related quality of life was also greater by the eighth week for patients treated with Stelara versus those treated with placebo.
Dr Philippe Szapary, Janssen Research & Development clinical development vice president, said: “STELARA is the first biologic approved for any indication that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, like ulcerative colitis. These induction data from the Phase 3 UNIFI study underscore the potential for this pathway in the treatment of UC, which may lead to a new effective and safe treatment option for UC patients in the future.”