Ulcerative Colitis: One Biologic Investigated, Two Others Compared

By Joe Elia

Edited by Susan Sadoughi, MD

Ulcerative colitis is the focus of two trials of monoclonal antibody therapies in the New England Journal of Medicine. Both trials were designed and conducted by drug makers.

In the first, ustekinumab — an antibody against a subunit of interleukins 12 and 23 — was compared against placebo among some 950 patients with moderate-to-severe ulcerative colitis. Patients received intravenous induction therapy and, later, subcutaneous maintenance injections. At week 44, ustekinumab was associated with more clinical remissions than placebo (roughly 44% vs. 24% of participants). Of note, ustekinumab is not currently FDA approved for ulcerative colitis — but is approved for psoriasis, psoriatic arthritis, and Crohn disease.

The second trial made a head-to-head comparison between infusions of vedolizumab (an antibody against a leukocyte integrin) and injections of adalimumab (which neutralizes tumor necrosis factor) in some 770 patients. Clinical remissions were more frequent at week 52 with vedolizumab than adalimumab (31% vs. 23%), but corticosteroid-free remission was higher with adalimumab than vedolizumab (22% vs. 13%).

Dr. Sunanda Kane weighs in on the findings in NEJM Journal Watch Gastroenterology. Have a look at the first links below.