Janssen is seeking to expand the scope of its psoriasis biologic Stelara in Europe to include the treatment of adults with severe active Crohn’s disease.
The Johnson & Johnson group has submitted an application to the European Medicines Agency based on data from the Phase III UNITI clinical development program, backing the efficacy and safety of the drug as induction and maintenance treatment.
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, faecal lactoferrin and calprotectin.
Crohn’s disease is a chronic inflammatory bowel disease that affects around 115,000 people in the UK and nearly 250,000 people in Europe. It’s cause is not known and currently there is no cure, and new treatment options are urgently needed.
Stelara - a human monoclonal antibody targeting interleukin-12 and -23 cytokines, which are believed to play an important role in immune-mediated diseases such as Crohn's - is already approved in Europe for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.