P3194 - Efficacy and Safety of Tulisokibart Maintenance Treatment in Tulisokibart Induction, Re-induction, and Delayed Induction Responders: Open-Label Extension of the ARTEMIS-UC Trial in Patients With Ulcerative Colitis

Bruce E. Sands, MD, MS, FACG¹, Sami Hoque, MD, PhD², Brian G. Feagan, MD³, Mark Yen, ⁴, Bin Dong, ⁴, Wen Zhou, ⁴, Silvio Danese, MD, PhD⁵
1Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA, New York, NY; 2Department of Gastroenterology, Barts Health NHS Trust, London, England, United Kingdom; 3Division of Gastroenterology, Department of Medicine, University of Western Ontario and Alimentiv, London, ON, Canada; 4Merck & Co., Inc., Rahway, NJ; 5Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Lombardia, Italy

Introduction: In the phase 2 ARTEMIS-UC study, a significantly higher proportion of participants on tulisokibart compared to placebo achieved clinical remission after 12 weeks of induction treatment in patients with moderately to severely active ulcerative colitis (UC).¹ This post-hoc analysis evaluates efficacy and safety in initial non-responders to 12-week induction dosing who achieved response upon re-induction and were given maintenance dosing in an open-label extension (OLE).

Methods: Participants (≥18 years) were randomized to intravenous tulisokibart 12-week induction (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10) or placebo and tested for anti-TL1A response likelihood. This analysis was done in Cohort 1 (positive and negative participants). Participants were classified as induction responders (reduction of ≥2 points and ≥30% in modified Mayo score from baseline, and a reduction ≥1 in rectal bleeding subscore or absolute rectal bleeding subscore ≤1 at week 12) or non-responders. Induction non-responders underwent a 12-week re-induction (or delayed induction for initial placebo participants) with open-label tulisokibart induction dosing. Cohort 1 induction, re-induction, and delayed induction responders were randomized to OLE maintenance dosing (tulisokibart 100 mg or 250 mg every 4 weeks) up to Week 50.

Results: In Cohort 1, 47 tulisokibart induction responders, 13 re-induction responders, and 29 delayed induction responders were randomized to OLE maintenance treatment with tulisokibart. Maintenance of treatment effect was generally similar with a trend for higher efficacy with tulisokibart 250 mg vs 100 mg, observed across the 3 groups (Table). The safety profile of tulisokibart maintenance treatment was similar across the 3 groups, with no new safety signals being observed.

Discussion: Tulisokibart was effective as a maintenance treatment in patients with moderately to severely active UC. The effect was generally similar across Cohort 1 tulisokibart induction, re-induction, and delayed induction responders. Tulisokibart maintenance treatment was well tolerated across the 3 groups. Taken altogether, a second induction regimen for tulisokibart non-responders may result in a long-term efficacy benefit without an increased safety risk. Larger trials are needed to confirm these findings.

References:

1. Sands BE et al. N Engl J Med. 2024; 391:1119─1129.


Figure: Table: Efficacy and fecal calprotectin

Disclosures:
Bruce Sands: AbbVie – Consultant. Abivax – Consultant, speaking fees. Adiso Therapeutics – Consultant. Agomab Therapeutics – Consultant. Alimentiv – Consultant. Amgen – Consultant. AnaptysBio – Consultant. Arena Pharmaceuticals – Consultant. Artugen Therapeutics – Consultant. Astra Zeneca – Consultant. Biolojic Design – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, speaking fees. Calibr – Consultant. Celgene – Consultant. Celltrion – Consultant. ClostraBio – Consultant. Eli Lilly & Company – Consultant, speaking fees. Enthera – Consultant. Enveda Biosciences – Consultant. Equillium – Consultant. Evommune – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Fzatat – Consultant. Galapagos – Consultant. Genentech (Roche) – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. Gossamer Bio – Consultant. Imhotex – Consultant. Index Pharmaceuticals – Consultant. Innovation Pharmaceuticals – Consultant. Inotrem – Consultant. Janssen R&D – Consultant, Grant/Research Support, speaking fees. Kaleido – Consultant. Kallyope – Consultant. Merck & Co., Inc., Rahway, NJ, USA – Consultant. Microba – Consultant. Mobius Care – Consultant. Morphic Therapeutics – Consultant. MRM Health – Consultant. Nexus Therapeutics – Consultant. Nimbus Discovery – Consultant. Odyssey Therapeutics – Consultant. Pfizer – Consultant, Grant/Research Support, speaking fees. Progenity – Consultant. Prometheus Biosciences – Consultant. Prometheus Laboratories – Consultant. Protagonist Therapeutics – Consultant. Q32 Bio – Consultant. Rasayana Therapeutics – Consultant. Recludix Therapeutics – Consultant. Reistone Biopharma – Consultant. Sanofi – Consultant. Spyre Therapeutics – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Takeda – Consultant, Grant/Research Support, speaking fees. Target RWE – Consultant. Teva – Consultant. Theravance Biopharma – Consultant, Grant/Research Support. TLL Pharmaceutical – Consultant. Tr1X – Consultant. Union Therapeutics – Consultant. Ventyx Biosciences – Consultant, Stock Options.
Sami Hoque: MSD – Grant/Research Support.
Brian G. Feagan: Abbvie – Advisory Committee/Board Member, Consultant, honoraria. Abivax – Consultant. Adiso – Consultant. AgomAb Therapeutics – Consultant. Allianthera – Consultant. Amgen – Consultant. AnaptysBio – Advisory Committee/Board Member, Consultant. Arena Pharma – Consultant. Atomwise – Consultant. Avoro Capital Advisors – Consultant. BioJamp – Consultant. Biora Therapeutics – Consultant. Blackbird Laboratories – Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Boxer Capital – Consultant. Celgene/BMS – Advisory Committee/Board Member, Consultant. Connect BioPharma – Consultant, Stock-publicly held company(excluding mutual/index funds). Cytoki – Consultant. Disc Medicine – Consultant. Duality – Consultant. EcoR1Capital – Advisory Committee/Board Member, Consultant. Eli Lilly – Advisory Committee/Board Member, Consultant. EnGene – Stock-publicly held company(excluding mutual/index funds). Equillium – Consultant. Ermium – Consultant. Evida – Stock-privately held company. First Wave – Consultant. Forbion – Consultant. Galapagos – Consultant. Galen Atlantica – Consultant. Genentech/Roche – Advisory Committee/Board Member, Consultant. Gilead – Consultant. GlaxoSmithKline – Advisory Committee/Board Member, Consultant. Gossamer Pharma – Consultant. Hinge Bio – Consultant. Imhotex – Consultant. Immunic Therapeutics – Consultant. Index Pharma – Consultant. Intercept – Consultant. JAKAcademy – Consultant. Janssen – Advisory Committee/Board Member, Consultant, honoraria; expert testimony. Japan Tobacco Inc. – Consultant. Kaleido Biosciences – Consultant. Klick Health – Consultant. Landos Biopharma – Consultant. Lenczner Slaght – Consultant. LifeSci Capital – Consultant. Lument AB – Consultant. Mage Biologics – Consultant. Merck – Advisory Committee/Board Member. Mestag – Consultant. Millennium – Consultant. MiroBio – Advisory Committee/Board Member, Consultant. Monte Rosa Therapeutics – Consultant. Morgan Lewis – Consultant. Morphic Therapeutics – Advisory Committee/Board Member, Consultant. Mylan – Consultant. Nexera – Consultant. Nexys Therapeutics – Consultant. Nimbus Therapeutics – Consultant. Odyssey – Consultant. OM Pharma – Consultant. OrbiMed – Consultant. Origo BioPharma – Advisory Committee/Board Member, Consultant. Orphagen – Consultant. Pandion Therapeutics – Consultant. Pendopharm – Consultant. Pfizer – Advisory Committee/Board Member, Consultant, honoraria. Progenity – Consultant. Prometheus Therapeutics and Diagnostics (Merck & Co., Inc., Rahway, NJ, USA) – Consultant. Protagonist – Consultant. PTM Therapeutics – Consultant. Q32 Bio – Consultant. Rebiotix – Consultant. REDX Pharma – Advisory Committee/Board Member, Consultant. Roche – Consultant. Roivant/Televant – Consultant. Sandoz – Consultant. Sanofi – Advisory Committee/Board Member, Consultant. Seres Therapeutics – Consultant. Silverback Therapeutics – Consultant. Sobi – Consultant. Spyre Therapeutics – Consultant. Surrozen Inc. – Consultant. Synedgen – Consultant. Takeda – Advisory Committee/Board Member, Consultant, honoraria. Teva – Advisory Committee/Board Member, Consultant. Thelium – Consultant. Tigenix – Consultant. Tillotts – Consultant. Triastek – Consultant. Ventyx – Consultant.
Mark Yen: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. – Employee, Stock Options.
Bin Dong: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. – Employee, Stock Options.
Wen Zhou: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. – Employee, Stock Options.
Silvio Danese: AbbVie – Consultant, Lecture fees. Alimentiv – Consultant. Allergan – Consultant. Amgen – Consultant, Lecture fees. AstraZeneca – Consultant. Athos Therapeutics – Consultant. Biogen – Consultant. Boehringer Ingelheim – Consultant. Celgene – Consultant. Celltrion – Consultant. Eli Lilly – Consultant. Enthera – Consultant. F. Hoffmann-La Roche Ltd – Consultant. Ferring Pharmaceuticals Inc. – Consultant, Lecture fees. Gilead – Consultant, Lecture fees. Hospira – Consultant. Inotrem – Consultant. Johnson & Johnson – Consultant, Lecture fees. MSD – Consultant. Mundipharma – Consultant. Mylan – Consultant, Lecture fees. Pfizer – Consultant, Lecture fees. Sandoz – Consultant. Sublimity Therapeutics – Consultant. Takeda – Consultant, Lecture fees. TiGenix – Consultant. UCB Inc. – Consultant. Vifor (International) Ltd. – Consultant.

Bruce E. Sands, MD, MS, FACG¹, Sami Hoque, MD, PhD², Brian G. Feagan, MD³, Mark Yen, ⁴, Bin Dong, ⁴, Wen Zhou, ⁴, Silvio Danese, MD, PhD⁵. P3194 - Efficacy and Safety of Tulisokibart Maintenance Treatment in Tulisokibart Induction, Re-induction, and Delayed Induction Responders: Open-Label Extension of the ARTEMIS-UC Trial in Patients With Ulcerative Colitis, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.