Ustekinumab May Benefit Crohn's Patients Unresponsive to TNFIs
(HealthDay News) — Patients with moderate-to-severe Crohn's disease who haven't responded to other treatments may benefit from the drug ustekinumab (Stelara), according to a study published in the Nov. 17 issue of the New England Journal of Medicine.
William Sandborn, M.D., a professor of medicine at the University of California, San Diego, and colleagues recruited two groups of patients, one with 741 participants, and the other with 628. These patients hadn't responded to anti-tumor necrosis factor treatment or had unacceptable side effects from it. The study volunteers were randomly assigned to receive either a single intravenous dose of ustekinumab or a placebo. The researchers then took 397 patients who showed a response to ustekinumab and randomly assigned them to receive regular injections of ustekinumab or a placebo every eight weeks or 12 weeks.
The researchers found that after 44 weeks, 53.1 percent of patients receiving ustekinumab injections every eight weeks were in remission. For patients getting ustekinumab every 12 weeks, 48.8 percent were in remission. This compared with 35.9 percent of those receiving a placebo.
Ustekinumab is a monoclonal antibody that blocks the action of the inflammatory agents interleukin-12 and interleukin-23. The drug had been approved for the treatment of psoriasis and is now approved for treating Crohn's disease as well. Ustekinumab was well tolerated and "we did not see increased rates of serious infection or cancer, compared with patients who received placebo," Sandborn told HealthDay.
Several authors disclosed financial ties to pharmaceutical companies, including Janssen Research and Development, which manufactures ustekinumab and funded the study.