P0593Impact of up to 3 years of continuous etrasimod treatment: Long-term efficacy results from the ELEVATE UC open-label extension

Abstract Background Etrasimod is an oral, once-daily (QD), sphingosine 1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis (UC). Cumulative safety data of etrasimod exposure in the global UC clinical programme have been reported.1 This analysis reports long-term efficacy in patients with UC who received up to 3 years of continuous etrasimod 2 mg QD treatment across qualifying parent studies and the ELEVATE UC open-label extension (OLE). Methods Patients who completed and responded to 52 weeks of etrasimod 2 mg QD in parent studies and continued treatment for up to 2 additional years in the ongoing ELEVATE UC OLE (NCT03950232) were included; data cut-off: 20 June 2024 (Figure). Clinical, symptomatic, endoscopic and histological efficacy endpoints were assessed at Week 52 and Week 104 of the OLE. Data are reported using observed cases with corresponding modified nonresponder imputation (mNRI) rates. Results Overall, 214 patients treated with etrasimod 2 mg QD were included, with a mean (standard deviation; SD) etrasimod exposure of 107.5 (52.5) weeks of OLE treatment, additional to 52 weeks in the parent study. At baseline, patients had a mean (SD) duration of UC and baseline modified Mayo score of 8.7 (7.7) years and 6.2 (1.2), respectively. Most patients (n = 172; 80.4%) were biologic/Janus kinase inhibitor naïve. At Week 52 and Week 104 of the OLE, clinical remission was observed in 59.1% (mNRI: 52.0%) and 59.6% (45.6%) of patients, respectively; all of whom were corticosteroid free for ≥12 weeks. At both Week 52 and Week 104 of the OLE, clinical response was observed in ∼90% of patients (mNRI: 80.0%, 66.4%), endoscopic improvement in ∼70% (mNRI: 59.0%, 48.3%), symptomatic remission in ∼83% (mNRI: 73.0%, 63.1%), histologic improvement in ∼74% (mNRI: 62.5%, 55.0%) and endoscopic improvement-histologic remission in ∼55% (mNRI: 46.0%, 38.3%; Table). Conclusion Etrasimod demonstrated maintenance of efficacy across clinical, endoscopic, symptomatic and histological endpoints for up to 3 years of continuous treatment, supporting durable efficacy. Future data readouts will continue to provide information on the long-term efficacy of etrasimod. Reference: 1. Vermeire S et al. J Crohns Colitis 2025; 19: i119–i121. Pfizer’s generative artificial intelligence tool MAIA was used to assist production of the abstract first draft. Authors reviewed/edited and take responsibility for the content. Conflict of interest: Sands, Bruce E: Consulting fees from AbbVie, Alimentiv, Adiso Therapeutics, Agomab, Amgen, AnaptysBio, AstraZeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Celltrion, Equillium, Ensho Therapeutics, Enthera, Enveda Biosciences, Evommune, Ferring, Fzata, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Immunyx Therapeutics, Index Pharmaceuticals, Innovation Pharmaceuticals, Kaleido, Kallyope, Merck & Co., Microba, Microbiotica, Mirador Therapeutics, Mitsubishi Tanabe Pharma, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, Palisade Bio, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biotherapeutics, Sanofi, Sorriso Pharmaceuticals, Surrozen, Target RWE, Teva, TLL Pharmaceutical, TR1X and Union Therapeutics Consulting and speaking fees from: Abivax Consulting and speaking fees and other support from: Lilly Research grants, consulting and speaking fees and other support from: Bristol Myers Squibb, Janssen/J & J Innovative Medicine, Pfizer Inc and Takeda Research grants and consulting fees from: Theravance Biopharma Consulting fees, stock and stock options from: Ventyx Biopharma. Dubinsky, Marla C: Consulting fees from: AbbVie, Abivax, Arena Pharmaceuticals, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Galapagos, Genentech, Gilead Sciences, Janssen Pharmaceuticals, Johnson & Johnson, Merck, Pfizer Inc, Prometheus Biosciences, Prometheus Laboratories, Sanofi, Sphyre, Takeda and UCB Shareholder/Royalties in: Trellus Health Directorship/Ownership interest in: Trellus Health. Armuzzi, Alessandro: Consulting fees from: AbbVie, Abivax, Alfa Sigma, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Enthera Pharmaceuticals, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Giuliani, Janssen, Lionhealth, MSD, Nestlé, Pfizer Inc, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Sanofi, Takeda, Teva Pharmaceuticals and Tillotts Pharma Grant/Research support from: Biogen, MSD, Pfizer Inc and Takeda Lecture/Speaker fees from: AbbVie, Abivax, AG Pharma, Alfa Sigma, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, Gilead Sciences, Janssen, Lionhealth, MSD, Novartis, Pfizer Inc, Roche, Samsung Bioepis, Sandoz, Takeda and Teva Pharmaceuticals Ma, Christopher: Consulting fees from: AbbVie, Alimentiv, Amgen, Anaptys Bio, AVIR Pharma Inc, Bristol Myers Squibb, Celltrion, Domain Therapeutics, Eli Lilly, Eupraxia, Ferring, Forte Biosciences, Fresenius Kabi, Gilead, Janssen, McKesson, Mirador Therapeutics, Pendopharm, Pfizer Inc, Prometheus Biosciences Inc, Roche, Sanofi, Takeda and Tillotts Pharma Speaker’s fees from: AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, Bristol Myers Squibb, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Organon, Pendopharm, Pfizer Inc, Sanofi, Takeda and Tillotts Pharma Research support from: AbbVie, Eli Lilly, Ferring and Pfizer Inc Royalties from: Springer Publishing. Blumenstein, Irina: Consulting and lecturer fees from: AbbVie, Amgen, Biogen, Celgene/BMS GmbH, Celltrion, Falk Foundation, Fresenius Kabi, Galapagos, Janssen-Cilag, Lilly, Merck, Pharmacosmos, Pfizer Inc, Takeda and Tillotts. Afzali, Anita: Co-founder/Board member of: Scrubs & Heels. Consulting fees from: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Sanofi, and Takeda. Grant/Research support from: AbbVie, Janssen, Lilly, Pfizer Inc, and Takeda. Speaker fees from: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, and Takeda. Smolinski, Patryk: Consulting fees: Janssen, PRO.MED.CS Praha a.s, and URGO. Speaker fees: Polpharma and PRO.MED.CS Praha a.s. Goetsch, Martina: Employee: Pfizer AG. Shareholder: Pfizer Inc. Lazin, Krisztina: Employee: Pfizer AG. Shareholder: Pfizer Inc. Keating, Michael: Employee and Shareholder: Pfizer Inc. Kudela, Maria: Employee: Pfizer Inc. Shareholder: Pfizer Inc. Zang, Chuanbo: Employee and Shareholder: Pfizer Inc. Segovia Medina, Michelle: Employee: Pfizer Inc. Ferreira Branquinho, Diogo: Employee: Pfizer. Shareholder: Pfizer. Woolcott, John: Employee: Pfizer Inc. Shareholder: Pfizer Inc. Danese, Silvio: Consultancy/Advisory fees from: AbbVie, Allergan, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Gilead Sciences, Hospira, Janssen, Johnson & Johnson, MSD, Mundipharma, Pfizer Inc, Roche, Sandoz, Takeda, TiGenix, UCB and Vifor Lecture/Speaker fees from: AbbVie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer Inc and Takeda Directorship/Ownership in: Gastroenterology and Endoscopy. Rubin, David T.: Consultancy/Advisory fees from: AbbVie, Abivax SA, Altrubio, Avalo Therapeutics, Bausch Health, Bristol Myers Squibb, Buhlmann Diagnostics Corp, Celltrion, ClostraBio, Connect BioPharma, Douglas Pharmaceuticals, Eli Lilly & Co., Foresee, Genentech (Roche) Inc., Image Analysis Group, InDex Pharmaceuticals, Iterative Health, Janssen Pharmaceuticals, Odyssey Therapeutics, Pfizer Inc, Sanofi, Takeda Pharmaceuticals, Throne and Vedanta Grant support from: GastroIntestinal Research Foundation, Helmsley Charitable Trust and Takeda Board of Trustees for: Cornerstones Health, Inc.