The New England Journal of Medicine has reported the results of a large clinical trial demonstrating the effectiveness of Stelara® (ustekinumab) in treating patients with active Crohn's disease.
Crohn’s disease and ulcerative colitis (collectively called inflammatory bowel disease, or IBD) result from a hyperactive immune system that attacks the gastrointestinal system. The immune system’s attack leads to inflammation of the intestines causing abdominal pain, diarrhea, rectal bleeding, and other symptoms. Immunotherapies for IBD aim to suppress the excessive, inappropriate immune response that is causing the inflammation.
More than five million people worldwide are living with IBD. Crohn’s disease affects approximately 700,000 Americans.2 The cause of Crohn’s disease is not known, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors. There is currently no cure for Crohn’s disease.2
The first drug to treat Crohn’s disease works by blocking tumor necrosis factor (TNF—a mediator of inflammation) and was approved in 1998. Since then several other drugs targeting TNF have come on the market. They are given by injection, either into a vein or under the skin.
Stelera is a monoclonal antibody that binds to a portion of the inflammation-causing cytokines interleukin-12 (IL-12) and IL-23, therefore blocking their activity. Stelara is already FDA approved for other inflammatory disorders and will be considered for use in Crohn’s in the near future.
The current trial results are for the UNITI-1 and 2 trials. UNITI-1 included 741 patients with Crohn’s disease who were treated with Stelara subcutaneous injection or placebo and directly compared.
The UNITI-2 trial included 628 patients in whom conventional therapy failed or unacceptable side effects occurred. Patients who completed these two induction trials then participated in IM-UNITI, in which the 397 patients who had a response to Stelara were treated with subcutaneous maintenance injections or placebo. Assessment of response to treatment was with the Crohn’s Disease Activity Index [CDAI] score.
The week 6 responses were significantly higher for Stelara compared to placebo for the UNITI-1 trial (33% vs. 21%) and the UNITI-2 trial (>51% vs. 28%), which presents Stelara as a new treatment option for individuals with Crohn’s disease.