The TL1A inhibitor tulisokibart was associated with better clinical, endoscopic, and patient-reported outcomes than placebo in patients with moderately to severely active UC in the induction part of the phase 2 ARTEMIS-UC trial (NCT04996797)1. During the 12-week induction phase, participants in the tulisokibart arm (n=68) received 1,000 mg intravenously administered tulisokibart at day 1, followed by 500 mg tulisokibart, every 4 weeks.
Responders could enter the open-label extension part to receive tulisokibart maintenance therapy for up to 170 weeks. The responders (n=47) were randomised 1:1 to 250 mg tulisokibart, every 4 weeks, or to 100 mg tulisokibart, every 4 weeks. Dr Christopher Ma (University of Calgary, Canada) presented the findings after 50 weeks of follow-up2.
The clinical remission rate was 32% in the 100 mg arm and 48% in the 250 mg arm. Next, endoscopic improvement was observed in 36% and 48% of the participants in the 100 mg arm and 250 mg arm, respectively. Furthermore, the clinical response rates were 59% and 68% for the low-dose and high-dose arms. Histologic improvement was documented for 67% of the participants in the 100 mg arm and 70% of the participants in the 250 mg arm.
“The severe adverse event rates were low, with 10% [n=3] of the patients in the 100 mg arm and 3% [n=1] of the patients in the 250 mg arm,” expressed Dr Ma. No acute infusion reactions or peri-infusion reactions were seen. The infection rate was 37% in the 100 mg arm and 46% in the 250 mg arm. “These were, however, predominantly upper respiratory infections. We did not see any serious infections or infections that would be related to systemic immunosuppression, such as herpes zoster,” clarified Dr Ma.
Altogether, tulisokibart displayed encouraging long-term efficacy data and favourable safety results in the current phase 2 study, supporting further investigations of this agent in phase 3 studies.