Patients with moderate to severe Crohn’s disease showed significant improvement on a drug called ustekinumab, according to the results of phase III clinical trials published in the New England Journal of Medicine.
The study was co-authored by Stephen Hanauer, MD, the Clifford Joseph Barborka Professor of Medicine in the Division of Gastroenterology and Hepatology.
Crohn’s disease is an inflammatory condition of the gastrointestinal tract, characterized by severe abdominal pain, diarrhea and weight loss. Current therapies, such as immunosuppressants, can help control symptoms of the disease, but they have limited efficacy and can carry an increased risk of infection.
Ustekinumab — a drug already used in the treatment of psoriasis and psoriatic arthritis — is a monoclonal antibody that blocks interleukin-12 and interleukin-23, proteins which are known to play a role in the inflammatory response.
In the study, investigators tested the drug in two trials of more than 1,300 patients with untreated Crohn’s. Participants were randomly assigned to receive one of two different doses of ustekinumab or a placebo over the course of eight weeks. Those who showed a clinical response to the drug were also then enrolled in a 44-week maintenance trial.
In all instances, ustekinumab was found to be significantly better than the placebo in inducing a clinical response, as well as maintaining remission. Further, rates of adverse side effects were similar in both the ustekinumab and placebo groups.
“The inflammatory bowel disease (IBD) program within the Digestive Health Center is actively engaged in clinical trials involving new therapies for Crohn’s disease and ulcerative colitis, with over a dozen protocols testing different mechanisms of action in a broad range of IBD patients,” Hanauer said.
Ustekinumab was approved by the FDA for moderately to severely active Crohn’s disease in September. The study was funded by Janssen Research and Development, which manufactures the drug. Hanauer is a paid consultant for Janssen.