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Tuesday Poster Session

Category: IBD

P3583 - Corticosteroid-Free Efficacy Outcomes in Patients Receiving Concomitant Corticosteroids at Baseline in the Etrasimod ELEVATE UC 52 Trial

Tuesday, October 24, 2023
10:30 AM – 4:00 PM PT
Location: Exhibit Hall
Has Audio
Bruce E. Sands, MD, MS, FACG1, Yvette Leung, MD, FRCPC2, David T. Rubin, MD3, Krisztina B. Gecse, MD, PhD4, Julian Panés, MD, PhD5, Martina Goetsch, MD6, Wenjin Wang, PhD7, Kevin Shan, PhD8, John C.. Woolcott, PhD7, Christina C.. Smith, PharmD, MBA7, Karolina Wosik, MSc, PhD9, Stefan Schreiber, MD10
1Icahn School of Medicine at Mount Sinai, New York, NY; 2University of British Columbia, Vancouver, BC, Canada; 3Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL; 4Amsterdam University Medical Center, Amsterdam, Noord-Holland, Netherlands; 5Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; 6Pfizer AG, Zurich, Zurich, Switzerland; 7Pfizer Inc., Collegeville, PA; 8Pfizer Inc., New York, NY; 9Pfizer Canada, Kirkland, PQ, Canada; 10University Hospital Schleswig-Holstein, Kiel, Schleswig-Holstein, Germany

Introduction: Etrasimod is an investigational, oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). In ELEVATE UC 52 (NCT03945188), etrasimod was superior to placebo (PBO) in achieving Week (Wk) 52 corticosteroid (CS)-free clinical remission (CR).1

Methods: This post hoc analysis reports CS-free efficacy and safety in patients (pts) on baseline (BL) CS. Pts were randomized 2:1 to once-daily etrasimod 2 mg or PBO using a treat-through design (12-wk induction and 40-wk maintenance period). At entry, pts could receive concomitant CS (prednisone [≤ 20 mg/day], budesonide [≤ 9 mg/day] or equivalent) if on a stable dose ≥ 4 wks immediately before screening endoscopy; from Wk 12, CS tapering was recommended. CS-free was defined as withdrawal of CS ≥ 12 wks prior to assessment timepoint. CS-free outcomes assessed were CS-free CR at Wk 52, CS-free endoscopic improvement (EI) at Wk 52, and CR at Wk 12 + CS-free CR at Wk 52. From Wk 12, 4-wk CS-free symptomatic remission (SR; 4 wk in contrast to ≥ 12-wks CS free) was analyzed at each visit. Logistic regressions examined associations with CS-free efficacy at Wk 52. Safety was assessed.

Results: At BL, 32.2% (93/289) and 29.2% (42/144) of etrasimod and PBO pts received CS; of these, significantly more etrasimod vs PBO pts achieved CS-free CR at Wk 52, CS-free EI at Wk 52 and CR at Wk 12 + CS-free CR at Wk 52 (all p < 0.05; Table). At Wks 40–52, there were significant differences (16.6–26.6%; p < 0.05) in 4-wk CS-free SR between etrasimod and PBO. In this subpopulation, being biologic/Janus kinase inhibitor-naïve was not a significant predictor of 12-wk CS-free CR at Wk 52 (odds ratio [OR]: 3.61; 95% confidence interval [CI] 0.91, 14.39; p=0.07); age, per 10-year increase, was significantly associated (OR: 1.51; 95% CI 1.03, 2.22; p=0.04). Etrasimod vs PBO pts with concomitant CS at BL experienced slightly more adverse events (AEs; not exposure adjusted) (71.0% [66/93] vs 61.9% [26/42]) but fewer serious AEs (6.5% [6/93] vs 14.3% [6/42]), including serious infections (0% [0/93] vs 7.1% [3/42]).

Discussion: More etrasimod vs PBO pts who received CS at BL met CS-free efficacy endpoints. Four-wk CS-free SR with etrasimod was superior to PBO from Wk 40. Concomitant CS use at BL had no notable negative effect on the safety of etrasimod, consistent with the overall ELEVATE UC 52 population.1

Reference
1. Sandborn WJ et al. Lancet 2023; 401: 1159-1171.


Disclosures:
Bruce Sands: AbbVie – Consultant. Abivax – Consultant, Speaker’s fees. Adiso Therapeutics – Consultant. Alimentiv – Consultant. Amgen – Consultant. Arena pharmaceuticals – Consultant. Artizan Biosciences – Consultant. Artugen Therapeutics – Consultant. AstraZeneca – Consultant. Bacainn Therapeutics – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, speaking fees and other support. Calibr – Consultant. Celltrion – Consultant. ClostraBio – Consultant. Connect Biopharm – Consultant. Cytoki Pharma – Consultant. Eli Lilly – Consultant, speaking fees and other support. Enthera – Consultant. Evommune – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. Gossamer Bio – Consultant. HMP Acquisition – Consultant. Imhotex – Consultant. Immunic – Consultant. InDex Pharmaceuticals – Consultant. Innovation Therapeutics – Consultant. Inotrem – Consultant. Ironwood Pharmaceuticals – Consultant. Janssen – Grant/Research Support, consulting and speaking fees and other support. Johnson & Johnson – Consultant. Kaleido Biosciences – Consultant. Kallyope – Consultant. Merck – Consultant. MiroBio – Consultant. Morphic Therapeutics – Consultant. MRM Health – Consultant. OSE Immunotherapeutics – Consultant. Pfizer Inc – Consultant, Grant/Research Support, speaking fees and other support. Progenity – Consultant. Prometheus Biosciences – Consultant. Prometheus Laboratories – Consultant. Protagonist Therapeutics – Consultant. Q32 Bio – Consultant. RedHill Biopharma – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Synlogic Operating Company – Consultant. Takeda – Grant/Research Support, consulting and speaking fees and other support. Target RWE – Consultant. Theravance Biopharma – Consultant, Grant/Research Support. TLL Pharmaceutical – Consultant. USWM Enterprises – Consultant. Ventyx Biosciences – Consultant, personal fees and stock options for consulting. Viela Bio – Consultant.
Yvette Leung indicated no relevant financial relationships.
David Rubin: AbbVie – Consultant, personal fees. AltruBio – Consultant, personal fees. Aslan Pharmaceuticals – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant, personal fees. Bristol Myers Squibb – Consultant. Celgene Chronicles – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. Corp/Syneos – Consultant. Eco R1 – Consultant. GastroIntestinal Research Foundation – Grant/Research Support. Genentech/Roche – Consultant. Gilead Sciences – Consultant, personal fees. Helmsley Charitable Trust – Grant/Research Support. Iterative Health – Consultant. Janssen Pharmaceuticals – Consultant, personal fees. Kaleido Biosciences – Consultant. Lilly – Consultant. Pfizer – Consultant, personal fees. Prometheus Biosciences – Consultant. Reistone Biopharma – Consultant, personal fees. Seres Therapeutics – Consultant. Takeda – Consultant, Grant/Research Support, Personal fees. Target RWE – Consultant. Trellus Health – Consultant.
Krisztina Gecse: Abbvie – Consultant, Speakers Bureau. Celltrion – Grant/Research Support, Speakers Bureau. Ferring Pharmaceuticals – Speakers Bureau. Galapagos – Grant/Research Support. Immunic Therapeutics – Consultant, Speakers Bureau. Janssen – Consultant, Speakers Bureau. Novartis – Consultant, Speakers Bureau. Pfizer Inc – Grant/Research Support. Samsung Bioepis – Consultant, Speakers Bureau. Takeda – Consultant, Speakers Bureau. Tillotts – Speakers Bureau.
Julian Panés: AbbVie – Grant/Research Support, Personal fees. Arena – Consultant. Athos – Consultant. Atomwise – Consultant. Boehringer Ingelheim – Consultant. Celgene – Consultant. Celltrion – Consultant. Ferring – Consultant, Speakers Bureau. Galapagos – Consultant. Genentech/Roche – Consultant. GlaxoSmithKline – Consultant. Immunic – Personal fees. Janssen – Consultant, payment for development of educational presentations. Mirum – Consultant. Morphic – Consultant. Origo – Consultant. Pandion – Consultant. Pfizer Inc – Grant/Research Support, payment for development of educational presentations. Progenity – Consultant. Revolo – Consultant. Takeda – payment for development of educational presentations. Theravance – Consultant. Wasserman – Consultant.
Martina Goetsch: Pfizer AG – Employee. Pfizer Inc – Stock-publicly held company(excluding mutual/index funds).
Wenjin Wang: Pfizer Inc – Employee, Stock Options.
Kevin Shan: Pfizer Inc – Employee, Stock-publicly held company(excluding mutual/index funds).
John Woolcott: Pfizer Inc – Employee, Stock Options.
Christina Smith: Pfizer Inc – Employee, Stock-publicly held company(excluding mutual/index funds).
Karolina Wosik: Pfizer Canada – Employee, Stock-publicly held company(excluding mutual/index funds).
Stefan Schreiber: AbbVie – Personal fees. Amgen – Personal fees. Arena Pharmaceuticals – Personal fees. Biogen – Personal fees. Bristol Myers Squibb – Personal fees. Celgene – Personal fees. Celltrion Healthcare – Personal fees. Dr. Falk Pharma – Personal fees. Eli Lilly – personal fees. Ferring Pharmaceuticals – personal fees. Fresenius Kabi – Personal fees. Galapagos – Personal fees. Gilead – Personal fees. Hikma Pharmaceuticals – Personal fees. I-Mab – Personal fees. Janssen Pharmaceuticals – Personal fees. Morphic – Personal fees. MSD – Personal fees. Mylan – Personal fees. Pfizer – Personal fees. Protagonist – Personal fees. ProventionBio – Personal fees. Sandoz/Hexal – personal fees. Takeda – Personal fees. Theravance Biopharma – Personal fees. UCB – personal fees.


Bruce E. Sands, MD, MS, FACG1, Yvette Leung, MD, FRCPC2, David T. Rubin, MD3, Krisztina B. Gecse, MD, PhD4, Julian Panés, MD, PhD5, Martina Goetsch, MD6, Wenjin Wang, PhD7, Kevin Shan, PhD8, John C.. Woolcott, PhD7, Christina C.. Smith, PharmD, MBA7, Karolina Wosik, MSc, PhD9, Stefan Schreiber, MD10. P3583 - Corticosteroid-Free Efficacy Outcomes in Patients Receiving Concomitant Corticosteroids at Baseline in the Etrasimod ELEVATE UC 52 Trial, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.