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Crohn’s disease: new Phase 3 data announced for STELARA

Phase 3 data presented at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO) showed that treatment with STELARA® (ustekinumab) induced clinical response and clinical remission in adult patients with moderate to severe Crohn’s disease who had previously failed or were intolerant to one or more anti-tumour necrosis factor (TNF)-alpha therapies (anti-TNF failure population). The Janssen Phase 3 UNITI-1 study, which included 741 people with Crohn’s disease, achieved its primary endpoint with ustekinumab treatment groups demonstrating significantly higher rates of clinical response at week 6 when compared with the placebo group (p=0.003, p=0.002, respectively).1 Major secondary endpoints of clinical response at week 8 (p?0.001) and clinical remission at week 8 (p<0.001, p=0.003, respectively) were also significantly higher among patients receiving ustekinumab compared with patients receiving placebo.1

These latest findings follow Phase 3 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 nai?ve to treatment with anti-TNF-alpha therapy.2 Regulatory 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, which is 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.3

“Results from the UNITI-1 study show that ustekinumab therapy induced clinical response and remission in patients with moderate to severe Crohn’s disease who had previously failed treatment with TNF inhibitors,” said Professor Paul Rutgeerts, Professor Emeritus of Medicine and Former Director of the Multidisciplinary Department of Endoscopy, Catholic University of Leuven, Belgium, and ustekinumab Crohn’s disease steering committee member. “With two Phase 3 induction studies demonstrating the efficacy and safety of ustekinumab in anti-TNF-alpha nai?ve, exposed and failure patient populations, we look forward to the forthcoming maintenance study findings. The need to induce and maintain control of disease symptoms is paramount in the treatment of Crohn’s disease.”

Patients participating in the Phase 3 UNITI-1 study received a single intravenous (IV) infusion of placebo, ustekinumab 130 mg or ustekinumab ~6 mg/kg (weight-tiered dosing: patients weighing less than or equal to 55 kg received 260 mg; patients weighing more than 55 kg and less than or equal to 85 kg received 390 mg; and patients weighing more than 85 kg received 520 mg) at week 0. All enrolled patients had previously failed or were intolerant to treatment with at least one anti-TNF-alpha therapy, and half of the enrolled patients had failed two or more anti-TNF-alpha therapies.1