Ustekinumab May Be Helpful in Treating Crohn's Disease
Though trial didn't meet primary end point, results were generally consistent with beneficial effect
TUESDAY, Oct. 14 (HealthDay News) -- The use of ustekinumab, a fully human IgG1 monoclonal antibody targeting the interleukin-12/23 p40 subunit, showed some signs of benefit in treating Crohn's disease, according to research published in the October issue of Gastroenterology.
William J. Sandborn, M.D., of the Mayo Clinic in Rochester, Minn., and colleagues analyzed data from 104 patients with moderate-to-severe Crohn's disease, who were divided into four crossover groups and given placebo and subcutaneous or intravenous ustekinumab on different schedules. In another study, 27 non-responders to infliximab were given four weekly subcutaneous injections or one intravenous infusion of the drug.
The primary end point for the first population was clinical response at week 8. In this group, the clinical response rates at week 8 were 49 percent for the combined ustekinumab groups and 40 percent for the combined placebo groups, the investigators found. In the second population, clinical responses at week 8 to subcutaneous and intravenous treatment were 43 and 54 percent, respectively, the report indicates.
"Induction of response and remission in patients with active Crohns disease who fail to respond to conventional therapy (including anti-tumor necrosis factor therapy) is an important unmet clinical need," the authors write. "Although the results of this phase 2, exploratory trial failed to definitively show that induction therapy with ustekinumab was superior to placebo in patients with moderate-to-severe Crohns disease, the data generally are consistent with a beneficial treatment effect," the authors write.
Centocor, Inc. provided support for the study, and several co-authors disclosed relationships with the company.