Phase III trial of Stelara (ustekinumab) meets endpoint in crohns disease- Janssen R&D

Phase III data presented for the first time showed treatment with Stelara (ustekinumab), from Janssen R&D, induced clinical response and clinical remission in patients with moderate to severe Crohn's disease who had previously failed conventional therapy, the majority of whom were naive to treatment with anti-tumor necrosis factor (TNF)-alpha therapy. The Phase III UNITI-2 study achieved its primary endpoint with ustekinumab treatment groups demonstrating significantly higher rates of clinical response at week 6 when compared with the placebo group.

At week 6, 52% of patients receiving ustekinumab 130 mg and 56% of patients receiving ustekinumab ~6 mg/kg achieved clinical response, as defined by a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 100 points, compared with 29% of patients receiving placebo. At week 8, 47% and 58% of patients receiving ustekinumab 130 mg and ustekinumab ~6 mg/kg, respectively, achieved clinical response, compared with 32% of patients receiving placebo. In addition, 31% of patients receiving ustekinumab 130 mg and 40% of patients receiving ustekinumab ~6 mg/kg achieved clinical remission at week 8, compared with 20% of patients receiving placebo.

In addition to significant improvements in signs and symptoms as measured by CDAI, both doses of ustekinumab resulted in statistically significant improvements in the Inflammatory Bowel Disease Questionnaire. 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. Through week 8, adverse events (AEs), serious AEs and infections (including serious infections) were reported in similar proportions across all treatment groups.

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 believed to play a role in immune-mediated diseases, including Crohn's disease.