P0924Long-term etrasimod efficacy in patients with Ulcerative Colitis stratified by prior biologic/JAKi experience: 2-year outcomes from ELEVATE UC OLE

Abstract Background Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis (UC). Cumulative safety data of up to 4 years of etrasimod exposure in the global UC clinical programme have been reported.1 We present the long-term efficacy of etrasimod 2 mg QD through 2 years in the ongoing ELEVATE UC open-label extension (OLE) study (NCT03950232), stratified by prior biologic/Janus kinase inhibitor (bio/JAKi) exposure. Methods The OLE enrolled patients from five parent studies (Figure). Efficacy endpoints were evaluated at Weeks 52 and 104 of the OLE, and included clinical remission, clinical response, endoscopic improvement, symptomatic response and symptomatic remission. Endpoints were assessed among bio/JAKi-naïve and -experienced patients (as defined at parent study baseline) who entered the OLE as clinical responders (data cut-off: June 20, 2024). Data are reported using observed cases with corresponding modified nonresponder imputation (mNRI) rates. Results Data from 390 etrasimod-treated patients were included (bio/JAKi naïve: n = 287; bio/JAKi experienced: n = 103). Among bio/JAKi-naïve patients, at Weeks 52 and 104 of the OLE, respectively, clinical response rates were 90.4% (mNRI: 76.7%) and 87.1% (63.9%), clinical remission rates were 55.8% (47.3%) and 52.7% (38.7%), endoscopic improvement rates were 63.9% (53.7%) and 63.3% (45.3%), symptomatic response rates were 96.6% (79.9%) and 95.4% (68.2%) and symptomatic remission rates were 82.5% (68.2%) and 76.0% (54.4%). Results were similar among bio/JAKi-experienced patients (Table); at Weeks 52 and 104 of the OLE, respectively, clinical remission rates were 57.7% (43.7%) and 55.0% (33.0%) and endoscopic improvement rates were 67.6% (46.6%) and 64.8% (35.0%). Conclusion Etrasimod demonstrated durable efficacy through 2 years of treatment in the OLE across clinical, endoscopic and symptomatic outcomes in patients with UC with and without prior bio/JAKi exposure. This study is ongoing with future data readouts expected. 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: Abbvie, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, AstraZeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Celltrion, Ensho Therapeutics, Enthera, Enveda Biosciences, Equillium, 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 speaker fees: Abivax Consulting and speaker fees, and other support: Lilly Research grants, consulting and speaker fees, and other support: Bristol Myers Squibb, Janssen/J & J Innovative Medicine, Pfizer and Takeda Research grants and consulting fees: Theravance Biopharma Consulting fees, stock and stock options: Ventyx Biopharma Dubinsky, Marla C: Consulting fees: 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. Directorship/Ownership interest: Trellus Health. Shareholder/Royalties: Trellus Health. Armuzzi, Alessandro: Consulting fees: 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: Biogen, MSD, Pfizer Inc, and Takeda. Lecture/Speaker fees: 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. Other: UEGW faculty member. Ma, Christopher: Consulting fees: 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, Tillotts Pharma. Grant/Research support: AbbVie, Eli Lilly, Ferring, Pfizer Inc. Lecture/Speaker fees: AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, Bristol Myers Squibb, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Organon, Pendopharm, Pfizer Inc, Sanofi, Takeda, Tillotts Pharma. Royalties: Springer Publishing. Blumenstein, Irina: Consulting and lecturer fees: AbbVie, Amgen, Biogen, Celgene/BMS GmbH, Celltrion, Falk Foundation, Fresenius Kabi, Galapagos, Janssen-Cilag, Lilly, Merck, Pfizer, Pharmacosmos, Takeda and Tillotts. Afzali, Anita: Consulting fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Sanofi and Takeda. Speaker fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Pfizer Inc and Takeda. Grant/Research support: AbbVie, Janssen, Lilly, Pfizer Inc and Takeda. Co-founder/Board member: Scrubs & Heels Foundation. Smolinski, Patryk: Consulting fees: Janssen, PRO.MED.CS Praha a.s, URGO. Lecture/Speaker fees: Polpharma, 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: Pfizer Inc. Shareholder: Pfizer Inc. Kudela, Maria: Employee: Pfizer Inc. Shareholder: Pfizer Inc. Zang, Chuanbo: Employee: Pfizer Inc. Shareholder: Pfizer Inc. Segovia Medina, Michelle: Employee: Pfizer Inc. Ferreira Branquinho, Diogo: Employee: Pfizer Inc. Shareholder: Pfizer Inc. Woolcott, John: Employee: Pfizer Inc. Shareholder: Pfizer Inc. Danese, Silvio: Lecture/ speaker fees: Abbvie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer Inc and Takeda. Consultancy/ advisory fees: 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. Directorship/ Ownership: Gastroenterology and Endoscopy. Rubin, David T.: Consultancy/Advisory: 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: GastroIntestinal Research Foundation, Helmsley Charitable Trust and Takeda. Board of Trustees: Cornerstones Health, Inc.