Tulisokibart looks good for Crohn’s disease

Induction treatment with the anti-TL1A monoclonal antibody tulisokibart appears to produce response in patients with moderately to severely active Crohn’s disease (CD) while being well tolerated, according to the results of a phase IIa trial.

The trial included 55 adults (mean age 39.1 yars, 62 percent male, 71 percent had prior exposure to biologic therapy) with a CD Activity Index (CDAI) of 220–450 and a Simple Endoscopy Score for CD (SES-CD) of ≥6 for ileocolonic or colonic disease or ≥4 for isolated ileal disease. These participants received tulisokibart intravenously at 1,000 mg on day 1 and 500 mg at weeks 2, 6, and 10.

Safety and endoscopic response at week 12 were the primary endpoints. Response was defined as a decrease in SES-CD of at least 50 percent from baseline.

At week 12, the percentage of participants with endoscopic response was 26.0 percent. In terms of safety, adverse events (AEs) occurred in 78 percent of participants, with most being mild to moderate in severity. The most common AEs were COVID-19 (11 percent), urinary tract infection (9 percent), anaemia (7 percent), nasopharyngitis (5 percent), and fatigue (5 percent).

Serious AEs were documented in 15 percent of participants, all of which were considered unrelated to the study drug. None of the participants died during the study.