Z Gastroenterol 2025; 63(08): e423-e424
DOI: 10.1055/s-0045-1810732
Abstracts | DGVS/DGAV
Kurzvorträge
Molekulare Therapie bei CED Donnerstag, 18. September 2025, 11:15 – 12:51, MZF 1

Long-term efficacy and safety of tulisokibart in participants with ulcerative colitis: the open-label extension of the phase 2 ARTEMIS-UC study

Authors

  • M Sossdorf

    1   MSD Sharp & Dohme GmbH, Munich, Deutschland

  • C Ma

    2   Division of Gastroenterology & Hepatology, Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Kanada

  • S Hoque

    3   Department of Gastroenterology, Barts Health NHS Trust, London, Vereinigtes Königreich

  • M P Sparrow

    4   Department of Gastroenterology, School of Translational Medicine, Monash University and Alfred Health, Melbourne, Australien

  • J K Anderson

    5   Merck & Co., Inc., Rahway, Vereinigte Staaten

  • M Yen

    5   Merck & Co., Inc., Rahway, Vereinigte Staaten

  • B Dong

    5   Merck & Co., Inc., Rahway, Vereinigte Staaten

  • B G Feagan

    6   Departments of Medicine, Epidemiology, and Biostatistics, Western University, London, Kanada

  • B E Sands

    7   Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, Vereinigte Staaten
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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]).

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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.



Publication History

Article published online:
04 September 2025

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