FRIDAY, Oct. 4, 2024 (HealthDay News) -- Tulisokibart, a tumor necrosis factor-like cytokine 1A monoclonal antibody, is more effective in inducing clinical remission in patients with moderately to severely active ulcerative colitis than placebo, according to a phase 2 study published in the Sept. 26 issue of the New England Journal of Medicine.
Bruce E. Sands, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues randomly assigned 135 patients with glucocorticoid dependence or failure of conventional or advanced therapies for ulcerative colitis to receive intravenous tulisokibart (1,000 mg on day 1 and 500 mg at weeks 2, 6, and 10) or placebo. Cohort 1 included patients regardless of genetic status, and cohort 2 included only 43 patients with a positive test for likelihood of response.
The researchers found that a significantly higher percentage of patients who received tulisokibart had clinical remission than those who received placebo (26 versus 1 percent). Among 75 patients with a positive test for likelihood of response (across cohorts), clinical remission occurred in a higher percentage of patients who received tulisokibart versus those who received placebo (32 versus 11 percent). The incidence of adverse events was similar in the tulisokibart and placebo groups, with most adverse events mild to moderate in severity.
"Additional evaluation and comparisons in larger patient populations are needed to further assess the value of the diagnostic test," the authors write.
The study was funded by Prometheus Biosciences, a subsidiary of Merck, which is developing tulisokibart.
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