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Tuesday Poster Session

Category: IBD

P4359 - Long-Term Efficacy and Safety of Intravenous (IV) Tulisokibart in Patients With Ulcerative Colitis (UC): Results From the Open-Label Extension (OLE) Period of the Phase 2 ARTEMIS-UC Study

Tuesday, October 29, 2024
10:30 AM – 4:00 PM ET
Location: Exhibit Hall E
Has Audio
Christopher Ma, MD1, Sami Hoque, MD2, Miles P.. Sparrow, MD3, Jaclyn K.. Anderson, DO4, Mark Yen, MD4, Bin Dong, PhD4, Brian G.. Feagan, MD5, Bruce E.. Sands, MD, FACG6
1University of Calgary, Calgary, AB, Canada; 2Barts Health NHS Trust, London, England, United Kingdom; 3School of Translational Medicine, Monash University and Alfred Health, Melbourne, VIC, Australia, Melbourne, Victoria, Australia; 4Merck & Co., Inc., Rahway, NJ; 5Western University, London, ON, Canada; 6Icahn School of Medicine at Mount Sinai, New York, NY

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. We report long-term efficacy and safety of tulisokibart among cohort 1 induction responders at week 50 from the OLE period of ARTEMIS-UC.

Methods: Cohort 1 of ARTEMIS-UC enrolled participants regardless of genetic-based diagnostic test status. After the 12-week induction period, in which randomized participants received IV tulisokibart (1000 mg on day 1; 500 mg at weeks 2, 6, 10) or placebo, participants had the option to continue in the OLE. Participants were classified as induction responders (defined as reduction of ≥2 points and ≥30% in modified Mayo score from baseline with a reduction ≥1 in rectal bleeding [RB] subscore or absolute RB subscore ≤1 at week 12) or induction nonresponders. Cohort 1 induction responders in the tulisokibart group were randomized to receive open-label IV tulisokibart 100 or 250 mg Q4W at 14–170 weeks. Efficacy outcomes are reported for induction responders from the tulisokibart group. Safety is reported for induction responders from tulisokibart and placebo groups. Descriptive statistics were used to summarize observed data.

Results: 47 cohort 1 induction responders in the tulisokibart group were randomized to receive tulisokibart 250 mg (n=25) or 100 mg (n=22). Improvements in clinical, endoscopic, and biomarker outcomes observed with tulisokibart were generally maintained through week 50 in both dose groups (Table). A greater proportion of patients achieved clinical and endoscopic outcomes with tulisokibart 250 vs 100 mg. In the safety population, (tulisokibart 250 mg, n=35; 100 mg, n=30), through week 50, AEs occurred in 63% and 77% of participants receiving tulisokibart 250 and 100 mg, respectively; most were mild to moderate in severity. Serious AEs occurred in 1 (3%) and two (7%) participants in the tulisokibart 250 and 100 mg groups, respectively.

Discussion: At week 50, maintenance of treatment effect was generally observed in cohort 1 induction responders. A trend for higher efficacy with tulisokibart 250 vs 100 mg was observed. Tulisokibart was well tolerated with no identified safety signals. Larger trials are needed to confirm these findings.


Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.


Disclosures:
Christopher Ma: AbbVie – Consultant, Speakers Bureau. Alimentiv (formerly Robarts Clinical Trials Inc.) – Consultant, Speakers Bureau. Amgen – Consultant, Speakers Bureau. AVIR Pharma Inc – Consultant, Speakers Bureau. BioJAMP – Consultant. Bristol Myers Squibb – Consultant, Speakers Bureau. Celltrion – Consulting Fees. Ferring – Consultant, Grant/Research Support, Speakers Bureau. Fresenius Kabi – Consultant, Speakers Bureau. Janssen – Consultant, Speakers Bureau. McKesson – Consultant. Mylan – Consultant. Pendopharm – Consultant, Speakers Bureau. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. Prometheus Biosciences Inc. – Consulting Fees. Roche – Consultant. Sanofi – Speaker Fee. Takeda – Consultant, Speakers Bureau.
Sami Hoque: Eli Lilly and Company – Advisory Committee/Board Member. Tillots – Advisory Committee/Board Member.
Miles Sparrow: AbbVie – Advisory Committee/Board Member, Speakers Bureau. BMS – Advisory Committee/Board Member. Celgene – Advisory Committee/Board Member. Celltrion – Advisory Committee/Board Member, Grant/Research Support. Dr. Falk Pharma – Speakers Bureau. Eli-Lilly – Advisory Committee/Board Member, Speakers Bureau. Emerge Health – Advisory Committee/Board Member. Ferring – Speakers Bureau. Gilead – Advisory Committee/Board Member, Grant/Research Support. Janssen – Advisory Committee/Board Member, Speakers Bureau. MSD – Advisory Committee/Board Member. Pfizer – Advisory Committee/Board Member, Speakers Bureau. Shire – Speakers Bureau. Takeda – Advisory Committee/Board Member, Speakers Bureau.
Jaclyn Anderson: Merck Sharp & Dohme LLC – Employee.
Mark Yen: Merck Sharp & Dohme LLC – Employee.
Bin Dong: Merck Sharp & Dohme LLC – Employee.
Brian Feagan: AbbVie – Advisory Committee/Board Member, Consultant, Speakers Bureau. AbolerIS – Consultant. AgomAB Therapeutics – Consultant. Allianthera – Consultant. Amgen – Advisory Committee/Board Member, Consultant. AnaptysBio – Advisory Committee/Board Member, Consultant. Applied Molecular Transport Inc – Advisory Committee/Board Member, Consultant. Arena Pharma – Consultant. Atomwise – Consultant. Avoro Capital Advisors – Consultant. Axio Research – Advisory Committee/Board Member. BioJamp – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Boxer – Consultant. Celgene/Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Celsius Therapeutics – Consultant. Connect BioPharma – Consultant, stock or other ownership interest. Cytoki – Consultant. Disc Medicine – Consultant. Duality – Consultant. EcoR1 Capital – Advisory Committee/Board Member, Consultant. Equillium – Consultant. Ermium – Consultant. First Wave – Consultant. First Word Group – Consultant. Galapagos – Consultant. Galen Atlantica – Consultant. Genentech/Roche – Advisory Committee/Board Member, Consultant. Gilead – Consultant. GlaxoSmithKline – Advisory Committee/Board Member, Consultant. Gossamer Pharma – Consultant, Stock Options. Hinge Bio – Consultant. Hot Spot Therapeutics – Consultant. Imhotex – Consultant. Immunic Therapeutics – Consultant. InDex Pharmaceuticals – Advisory Committee/Board Member, Consultant. JAKAcademy – Consultant. Janssen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Japan Tobacco Inc. – Consultant. Kaleido Biosciences – Consultant. L.E.K. Consulting – Consultant. Landos Biopharma – Consultant. Leadiant – Consultant. Lenczner Slaght – Consultant, payment for expert testimony. LifeSci Capital – Consultant. Lilly – Advisory Committee/Board Member, Consultant. Lument AB – Consultant. Millennium – Consultant. MiroBio – Advisory Committee/Board Member, Consultant. Morgan Lewis – Consultant, payment for expert testimony. Morphic Therapeutics – Advisory Committee/Board Member, Consultant. Mylan – Consultant. OM Pharma – Consultant. Origo BioPharma – Advisory Committee/Board Member, Consultant. Orphagen – Consultant. Pandion Therapeutics – Consultant. Pendopharm – Consultant. Pfizer Inc – Advisory Committee/Board Member, Consultant, Grant/Research Support. Play to Know AG – Consultant. Progenity – Advisory Committee/Board Member, Consultant. Prometheus – Advisory Committee/Board Member, Consultant. Protagonist – Consultant. PTM Therapeutics – Consultant. Q32 Bio – Consultant. Rebiotix – Consultant. REDX – Advisory Committee/Board Member, Consultant. Roche – Consultant. Sandoz – Consultant. Sanofi – Advisory Committee/Board Member, Consultant. Seres Therapeutics – Consultant. Silverback Therapeutics – Consultant. Surrozen Inc. – Consultant. Takeda – Advisory Committee/Board Member, Consultant, Speakers Bureau. Teva – Advisory Committee/Board Member, Consultant. Thelium – Consultant. Tigenix – Consultant. Tillotts Pharma – Advisory Committee/Board Member, Consultant. Ventyx Biosciences – Consultant. VHSquared Ltd – Consultant. Viatris – Consultant. Ysios – Consultant. Ysopia – Consultant. Zealand Pharma – Consultant.
Bruce Sands: AbbVie – Consultant. Abivax – Consultant, Speakers Bureau. Adiso Therapeutics – Consultant. Agomab – Consultant. Alimentiv – Consultant. Amgen – Consultant. AnaptysBio – Consultant. Arena Pharmaceuticals – Consultant. Artugen Therapeutics – Consultant. AstraZeneca – Consultant. Biolojic Design – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, Other support, Speakers Bureau. Calibr – Consultant. Celgene – Consultant. Celltrion – Consultant. ClostraBio – Consultant. Enthera – Consultant. Envied Biosciences – Consultant. Equilium – Consultant. Evommune – Consultant. Ferring – Consultant. Fiat – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech (Roche) – Consultant. Gilead Sciences – Consultant. Glaxo SmithKline – Consultant. Gossamer Bio – Consultant. Imhotex – Consultant. Index Pharmaceuticals – Consultant. Innovation Pharmaceuticals – Consultant. Inotrem – Consultant. Janssen – Consultant, Grant/Research Support, Other support, Speakers Bureau. Kaleido – Consultant. Kallyope – Consultant. Lilly – Consultant, other support, Speakers Bureau. 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 Inc – Consultant, Grant/Research Support, Other support, Speakers Bureau. 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, Other support, Speakers Bureau. Target RWE – Consultant. Teva – Consultant. Theravance Biopharma – Consultant, Grant/Research Support. TLL Pharmaceutical – Consultant. Tr1X – Consultant. Union Therapeutics – Consultant. Ventyx Biopharma – Consultant, Stock Options, Stock-publicly held company(excluding mutual/index funds).


Christopher Ma, MD1, Sami Hoque, MD2, Miles P.. Sparrow, MD3, Jaclyn K.. Anderson, DO4, Mark Yen, MD4, Bin Dong, PhD4, Brian G.. Feagan, MD5, Bruce E.. Sands, MD, FACG6. P4359 - Long-Term Efficacy and Safety of Intravenous (IV) Tulisokibart in Patients With Ulcerative Colitis (UC): Results From the Open-Label Extension (OLE) Period of the Phase 2 ARTEMIS-UC Study, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.