Phase III trial of Stelara (ustekinumab) meets primary endpoint in Crohn's disease- Janssen

Phase III data presented at the 11th Congress of the European Crohn's and Colitis Organisation showed that treatment with Stelara (ustekinumab), from Janssen, induced clinical response and clinical remission in adult patients with moderate to severe Crohn's disease who had previously failed or were intolerant to treatment with one or more anti-tumour necrosis factor (TNF)-alpha therapies. The Janssen Phase III UNITI-1 study, which included 741 patients, achieved its primary endpoint with ustekinumab treatment groups demonstrating significantly higher rates of clinical response at week 6 when compared with the placebo group. Major secondary endpoints of clinical response and clinical remission at week 8 were also significantly higher among patients receiving ustekinumab compared with patients receiving placebo.

These latest findings follow Phase III results from the UNITI-2 study, which demonstrated the efficacy and safety of ustekinumab in patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy. Applications seeking approval of ustekinumab for the treatment of moderately to severely active Crohn's disease are currently under review in Europe and the United States. Ustekinumab, approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in many countries, is a monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, including Crohn's disease.

Comment: These latest findings supplement Phase III results from the UNITI-2 study, which demonstrated the efficacy and safety of ustekinumab in patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy.