Efficacy and safety results of tulisokibart re-induction treatment in participants with ulcerative colitis in the Phase 2 ARTEMIS-UC clinical trial

Introduction: Tulisokibart is a monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), a key regulator of inflammation and fibrosis in ulcerative colitis (UC). The Phase 2 ARTEMIS-UC study showed that a higher percentage of tulisokibart participants achieved clinical remission after 12 weeks compared to placebo [1].

Objectives: This analysis evaluated the effects of re-induction treatment for participants who did not respond during the initial 12-week induction phase of the study.

Methods: Participants (≥18 years) with moderate to severe active UC with conventional/advanced treatment failure were randomized (1:1 ratio) to placebo or 12 weeks of intravenous tulisokibart (1000 mg on Day 1 and 500 mg on Weeks 2, 6, and 10). The study included 2 cohorts based on a genetic diagnostic test assessing response likelihood to anti-TL1A treatment. Cohort 1 included participants stratified by Dx results, while Cohort 2 included only Dx-positive participants. Cohort 1 is used for post-hoc analyses of induction non-responders, defined as those who did not achieve a≥2-point reduction and≥30% in modified Mayo score at week 12 accompanied by a reduction≥1 in rectal bleeding sub score or absolute rectal bleeding subscore≤1 at week 12. Efficacy and safety were assessed at Week 26 after re-induction.

Results: In Cohort 1, 67 and 68 participants were randomized to receive placebo or tulisokibart induction treatment, respectively. At Week 14, 41 (placebo) and 21 (tulisokibart) induction non-responders entered re-induction and received 12-week open label tulisokibart treatment. At Week 26, 48% and 63% of participants who received initial 12-week of tulisokibart treatment (total 24-week tulisokibart treatment) and 63% and 76% of participants who received initial 12-week placebo treatment (total 12-week tulisokibart treatment) achieved symptomatic improvement and symptomatic response, respectively. Re-induction with tulisokibart was well tolerated with no serious AEs or discontinuations due to AEs and no new safety signals (Table).

Conclusions: Re-induction treatment with tulisokibart is effective in participants who did not respond to initial induction treatment. Additionally, up to two tulisokibart induction regimens of 24 weeks is well tolerated with no new safety signals identified ([Fig. 1]).

Fig. 1  

Publikationsverlauf

Artikel online veröffentlicht:
04. September 2025

• References

• 1 Sands, et al. N Engl J Med. 2024 391. 1119-29