P1103 Mirikizumab demonstrated high treatment persistence and effectiveness in a real-world retrospective study in Canadian adult patients with moderately to severely active Ulcerative Colitis

Abstract Background Mirikizumab is approved for adults with moderate-to-severe ulcerative colitis (UC) based on evidence from randomised clinical trials.1 However, real-world evidence on treatment persistence and clinical outcomes in routine practice is limited. This analysis evaluated treatment persistence and effectiveness among patients with UC receiving mirikizumab in a Canadian real-world setting. Methods Adults (≥18 years) with moderate-to-severe UC enrolled in the LillyPlus® Patient Support Program in Canada who received at least 1 dose of mirikizumab (index date) between 26 October 2023 and 28 April 2025 were included. Persistence was defined as continuous mirikizumab treatment until reported discontinuation.2 Clinical outcomes assessed included bowel urgency (BU; scored 0-10), rectal bleeding (RB; scored 0-3), and stool frequency (SF; scored 0-3), with higher scores indicating more severe symptoms/higher symptom severity. Scores were collected at baseline and at weeks 4, 12, and 24 (+4-week window after each touchpoint). Persistence and clinical outcomes were evaluated up to 24 weeks post-index by prior advanced therapy (AT) subgroup (AT-naïve and AT-experienced) using descriptive statistics. Results The cohort (N = 774) was 51.9% female with a mean (standard deviation [SD]) age of 46.5 (17.4) years, and 87.0% of participants were AT-experienced. Treatment persistence rates were 98.0%, 92.6%, and 80.9% at 4, 12, and 24 weeks, respectively (Figure 1). Persistence rates trended higher in AT-naïve than in AT-experienced patients at week 24. At baseline, the overall mean (SD) BU, RB, and SF scores were 6.83 (2.90), 1.41 (1.08), and 2.22 (1.05), respectively (Figure 2). Changes to outcome scores were observed as early as week 4. By week 24, the overall mean (SD) BU, RB, and SF scores had decreased to 2.98 (2.67), 0.44 (0.72), and 0.86 (0.92), respectively. Conclusion In this real-world setting, which included a high proportion of AT-experienced participants (87.0%), mirikizumab demonstrated treatment persistence through 24 weeks of initial treatment. Improvements in BU, RB, and SF scores were observed as early as 4 weeks and continued over 24 weeks in both AT-naïve and AT-experienced patients. References: 1. D’Haens G, Dubinsky M, Kobayashi T, et al; LUCENT Study Group. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. doi:10.1056/NEJMoa22079402. 2. Mirikizumab (Omvoh). Package insert. Eli Lilly and Company; 2025. Conflict of interest: Jairath, Vipul: Consulting Fees: Abbvie, Alimentiv, Amgen, Anaptys Bio, Asahi Kasei, Asieris, Astra Zeneca, Attovia, Blackbird Labs, BMS, Boehringer Ingleheim, Biomebank, Caldera, Calluna, Catalytic Health, Celltrion, Ensho, Enthera, Exeliome Biosciences, Ferring, Fresenius Kabi, Gilead, Granite Bio, GSK, Janssen, Lilly, Merck, Mountainfield, MRM Health, Nxera, Organon, OSE Immunotherapeutics, Pendopharm, Pioneering Medicine, Pfizer, Prometheus, Roche/Genentech, Sanofi, SCOPE, Shattuck Labs, Sorriso, Spyre, Synedgen, Takeda, Teva, Tillotts, Union Therapeutics, Ventus, Ventyx, Vividion, Xencor, Zealand Pharma. Panaccione, Remo: Grant: Abbvie, Janssen, Pfizer, Takeda Other: Consultant for: Abbott, AbbVie, Abbivax, Alimentiv (formerly Robarts), Amgen, AnaptysBio, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Spyre Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Union Biopharma, Viatris, Ventyx, UCB Speaker’s Fees for: AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Gilead Sciences, Janssen, Merck, Organon, Pfizer, Roche, Sandoz, Shire, Takeda Pharmaceuticals Advisory Boards for: AbbVie, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, SandozShire, Sublimity Therapeutics, Takeda Pharmaceuticals, Ventyx. Bessissow, Talat: Speaker, consultant and research support from Abbvie, Alimentiv, Bristol-Myers-Squibb, CSF Vifor, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Gilead, Iterative scope, Johnson and Johnson, Merck, Mirium, Pendopharm, Pentax, Pfizer, Roche, Sandoz, Sanofi, Takeda, Vial Pharma Bressler, Brian: Personal Fees: Janssen, Abbvie, Takeda, Pfizer, Alimentiv, Pendopharm, Genentech, Merck, CSL Other: Stock Options: Qu Biologics, Dova Health Intelligence Ng, Ginnie: Dr. Ginnie Ng is a consultant employed by IQVIA Solutions Canada Inc. to support this study, sponsored by Eli Lilly Canada Inc. Glass, Jennifer: Jennifer Glass is an employee of Eli Lilly Canada Inc. and a shareholder of Eli Lilly and Company. Braun, Marta: Employee and shareholder of Eli Lilly and Company. Movsessian, Taline: Taline Movsessian is an employee of Eli Lilly Canada Inc. and a shareholder of Eli Lilly and Company. Feagan, Brian Gordon: Consulting Fees: AbbVie, Abivax, Adaxion, Adiso, AgomAB Therapeutics, Akros, Alira Health, Ally Bridge Group, Apini Therapeutics, Argenx, Attovia Tx, Avoro Capital Advisors, Belmore Law, Biora Therapeutics, Blackbird Laboratories, Boehringer-Ingelheim, BMS, Boxer Capital, Celgene/BMS, Clarivate, Connect Biopharm, EcoR1, Eli Lilly, Ensho Therapeutics, Equillium, Evida, Enveda, Evommune Inc. Faes Farma, First Wave, Forbion, Galapagos, Genentech/Roche, General Atlantic, Genesis Therapeutics, Gerson Lehrman Group, Gilead, Guidepoint, Imhotex, ImiDomics, Immunic Therapeutics, Janssen, Japan Tobacco Inc., LifeMine Therapeutics, Mage Biologics, Merck, Mirador Therapeutics, Mobius Care, Monte Rosa Tx, Morphic Therapeutics, Nimbus Therapeutics, Novartis, Nxera, OncoC3, Palisade Bio, Pendopharm, Pfizer,Q32 Bio, REDX, Roche, Sanofi, Sobi, Sorriso, Spyre Therapeutics, Sun Pharma, Surrozen Inc., Synedgen, Takeda, Tegus Inc., Teva, Tillotts, Trex Bio, TR1X Inc. TVM Lifesciences, Ventyx Biosciences, Versant Ventures, Vida Ventures, Ysios Capital, Zagbio Stock Shareholder: Connect Biopharm, EnGene, Evida, SRT, Imidomics, Enveda