Phase III results for Stelara (ustekinumab) in Crohn's disease published in New England Journal of Medicine- Janssen Research & Development

Results from three pivotal Phase III studies published in The New England Journal of Medicine show that treatment with Stelara (ustekinumab), from Janssen Research & Development, induced and maintained both clinical response and remission in a significantly greater proportion of adult patients with moderately to severely active Crohn's disease compared to placebo. These results were demonstrated in two separate induction studies as well as in a maintenance study which assessed treatment effect one year after initiation of Stelara treatment.

The UNITI Phase III development program consisted of two eight-week induction studies, one in patients who had previously failed or were intolerant to treatment with one or more anti-tumor necrosis factor (TNF)-alpha therapies (UNITI-1) and the other in patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy (UNITI-2). Patients then continued into a 44-week maintenance study (IM-UNITI).

Comment: these pivotal studies supported the recent approval by the U.S. FDA and the recent approval by the European Commission of Stelara for the treatment of moderately to severely active Crohn's disease in adults. Stelara is a monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, which play a role in immune-mediated diseases, including psoriasis, psoriatic arthritis and Crohn's disease.

See: "Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease" Brian G. Feagan et al. N Engl J Med 2016; 375:1946-1960 November 17, 2016 DOI: 10.1056/NEJMoa1602773