Introduction: Tumor necrosis factor–like cytokine 1A (TL1A) is a regulator of inflammation and
fibrosis in inflammatory bowel disease. Tulisokibart, an anti-TL1A monoclonal antibody,
demonstrated efficacy without clinically meaningful safety findings vs placebo after
a 12-week induction in adults with moderately to severely active UC in the multicenter,
double-blind, placebo-controlled phase 2 ARTEMIS-UC study. [1]
Objectives: We report long-term efficacy and safety of tulisokibart among cohort 1 induction
responders at week 50from the OLE period of ARTEMIS-UC ([Fig. 1]).
Fig. 1
Methodology: Participants were enrolled into 2 cohorts based on a genetic diagnostic test (Dx):
cohort 1 (Dx-positive and negative) and cohort 2 (Dx-positive only; not reported here).
Induction dosing was intravenous (IV) tulisokibart 1000 mg (day 1) and 500 mg (weeks
2, 6, and 10) or placebo. At week 14, induction responders (reduction of≥2 points
and≥30% in modified Mayo score [mMS] from baseline, and reduction≥1 in rectal bleeding
subscore or absolute rectal bleeding subscore≤1 at week 12) were randomized (stratified
by Dx status) to open-label IV tulisokibart 100 mg or 250 mg every 4 weeks. We report
clinical, endoscopy, biomarker, and safety outcomes up to week 50 for cohort 1 tulisokibart
induction responders. Efficacy outcomes include clinical remission, endoscopic improvement,
and fecal calprotectin.
Results: Tulisokibart induction responders (47/68) were randomized to tulisokibart 100 mg
(n=22) or 250 mg (n=25). Clinical, endoscopic, and biomarker outcomes are shown in
the Table. In the safety population, (tulisokibart 100 mg, n=30; 250 mg, n=35), adverse
events (AEs) occurred in 77% and 63% of participants, respectively; most were mild
to moderate in severity. Serious AEs occurred in 3% and 7% of patients in the 100
mg and 250 mg groups, respectively.
Conclusion: At week 50, maintenance of treatment efficacy was generally observed in cohort 1
induction responders in the tulisokibart group. A trend for higher efficacy with tulisokibart
250 mg vs 100 mg maintenance treatment was observed at week 50. Tulisokibart was well
tolerated with no identified safety signals.
