Johnson & Johnson’s psoriasis biologic Stelara has shown efficacy in inducing a clinical response and remission in patients with Crohn’s disease, providing the drugmaker with crucial evidence to support expanding the drug’s label.
The large-scale Phase III trial involved 628 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.
According to the results, after six weeks’ treatment 52% of patients taking Stelara (ustekinumab) 130mg and 56% receiving the 6mg/kg dose achieved a clinical response, versus 29% in the placebo arm. After eight weeks (a secondary endpoint), the figures were 47% and 58% compared to 32%, respectively.
Both doses of Stelara also resulted in statistically significant improvements in the Inflammatory Bowel Disease Questionnaire, a health-related quality of life measure for patients with the condition, as well as markers of inflammation, including C-reactive protein, fecal lactoferrin and calprotectin, the firm noted.
“Findings from this Phase III programme provide an important first look into the efficacy and safety of Stelara induction therapy in the treatment of inflammatory bowel disease – a disease where new therapeutic options are needed as the incidence continues to rise globally,” said study investigator Brian Feagan, chief executive and senior medical director of Robarts Research Institute, University of Western Ontario.
J&J said it would be filing applications this year for Stelara as a treatment for moderate to severe Crohn’s, a chronic inflammatory condition of the gastrointestinal tract that affects around 700,000 Americans and nearly 250,000 Europeans.
