The trial showed that Stelara induced clinical remission in a significantly greater proportion of UC patients at week 8 compared to placebo at both doses studied.
Major secondary endpoints such as the proportion of patients in clinical response, endoscopic healing and improvement in health-related quality of life were also higher at week 8 among patients securing Stelara compared to patients receiving placebo.
The Unifi phase 3 study was designed to assess the safety and efficacy of Stelara induction and maintenance dosing to treat moderate to severe UC in adults who showed an inadequate response to or were unable to tolerate conventional or biologic therapies.
The eight-week duration is compulsory for each participant in the induction study. Participants achieving clinical response in the induction study are eligible for the maintenance study, which is 44 weeks duration.
The primary endpoint of the induction study is clinical remission at week 8, while the primary endpoint for the maintenance study is clinical remission at week 44 among responders to a single IV Stelara infusion.
Stelara, which is a human IL-12 and IL-23 antagonist, secured approval in the US to treat adults and children 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
It is also approved to treat adult patients 18 years or older with active psoriatic arthritis, as well as moderately to severely active Crohn’s disease who have failed or were intolerant to immunomodulators or corticosteroids.
Janssen Research & Development clinical development vice president Dr Philippe Szapary 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.”