TULISOKIBART, a tumour necrosis factor–like cytokine 1A (TL1A) monoclonal antibody, has demonstrated significant potential in inducing clinical remission in patients with moderately-to-severely active ulcerative colitis (UC).
In a randomised, controlled trial, patients with glucocorticoid dependence or failure of conventional and advanced UC therapies were assigned to receive either intravenous tulisokibart (1,000 mg on Day 1, then 500 mg at Weeks 2, 6, and 10) or a placebo. The trial consisted of two cohorts: Cohort 1 included patients regardless of test status, while Cohort 2 focused solely on those with a positive test for likelihood of response.
The primary endpoint was clinical remission at Week 12. In Cohort 1, which included 135 patients, those treated with tulisokibart showed a much higher rate of remission compared to those on placebo (26% versus 1%, respectively). The difference was statistically significant (95% CI: 14–37; P<0.001), with a 25 percentage point difference in clinical remission.
In Cohort 2, which included 43 patients, the results were similarly promising. Among the 75 patients with a positive response likelihood test across both cohorts, 32% of those receiving tulisokibart reached clinical remission compared to only 11% in the placebo group (95% CI: 2–38; P=0.02).
The safety profile of tulisokibart was comparable to placebo, with most adverse events being mild-to-moderate in severity. The study suggests that tulisokibart could be an effective treatment option for patients with UC who have not responded to conventional therapies.
Ada Enesco, EMJ
Reference
Sands BE et al.; ARTEMIS-UC Study Group. Phase 2 trial of anti-TL1A monoclonal antibody tulisokibart for ulcerative colitis. N Engl J Med. 2024;391(12):1119-1129.
