Abstract Background In Denmark, the prevalence of inflammatory bowel disease has doubled during the past two decades1. Mirikizumab, an IL-23p19 inhibitor, has been available to use in Denmark since April 2024 for moderately to severely active ulcerative colitis (UC), with a recommended use of 3 intravenous induction doses, followed by subcutaneous maintenance every 4 weeks. However, real-world data on treatment persistence and clinical outcomes remains limited. We report an interim analysis of a population-based registry study describing baseline clinical characteristics and 6-month persistence data among adults initiating mirikizumab for moderately to severely active UC in Danish clinical practice. Methods This population-based study used data from multiple Danish national registries. Adults (≥18 years) with UC diagnosed between January 1977 and April 2025, initiating mirikizumab, were followed for up to 6 months. Inclusion required ≥2 registered UC diagnoses and ≥1 mirikizumab administration. Treatment discontinuation was defined as the absence of any subsequent administration within the period covered by the last recorded dose (i.e., the expected end of its supply) plus a 5-week grace period, treatment switch, colectomy, or death. Demographic and clinical characteristics were summarized as mean (standard deviation SD) or percentages (%). Preliminary treatment persistence was illustrated using Kaplan-Meier plots based on this interim dataset. Results Total of 333 patients were included in the cohort. Mean age was 43.7 years (SD 16.6), and 51.7% male; mean disease duration was 8.0 years (SD ± 8.7). Most patients had prior exposure to corticosteroids (97.0%) and advanced therapies (97.6%) with 26.1% having received ≥3 prior advanced therapies. Concomitant corticosteroid and immunomodulator use were reported in 41.7% and 3.0% of patients, respectively (Table). Preliminary findings showed that treatment persistence (n = 322) was 90% (95% CI: 86%–94%) at 3 months and 67% (95% CI: 60%–74%) at 6 months (Figure). Conclusion In this real-world, highly treatment-experienced Danish cohort, mirikizumab demonstrated a 6-month treatment persistence estimate of 67% in adults receiving this treatment for moderately to severely active UC, supporting its effectiveness in routine clinical practice. Future investigations will report on further long-term outcomes in this population. Reference: 1. Agrawal M, Christensen HS, Bøgsted M, Colombel JF, Jess T, Allin KH. The rising burden of inflammatory bowel disease in Denmark over two decades: A nationwide cohort study. Gastroenterology. 2022;163(6):1547-1554.e5. doi:10.1053/j.gastro.2022.07.062. Conflict of interest: Larsen, Lone: Speaker fee from Takeda, Eli Lilly, Abbvie Share holder Novo Nordisk A/S Advisory Board for Tillotts, Abbvie, Eli Lilly, Celltrion Consultancy for Eli Lilly Julsgaard, Mette: Grant: Research grants for investigator-driven studies from Takeda and Novo Nordisk Foundation (grant no. NNF23OC0081717) Personal Fees: Consultation fee: Ferring, Orion Pharma, and Takeda. Speaker’s fees: Tillotts Pharma, Eli Lilly, MSD, Ferring, and Takeda. Advisory board: PharmaCosmos, Eli Lilly, AbbVie and Tillotts Pharma. Knudsen, Torben: Authorship support: Eli Lilly Consulting fee: Glaxo, Zealand Pharma Payment/honoraria for lectures: Janssen, Eli Lilly, Takeda, Pfizer, Bristol Myers Squibb Travel/meeting support: Takeda, Eli Lilly Advisory board: Tillotts, Janssen, Eli Lilly, Abbvie Attauabi, Mohamed: Research grants from Novo Nordisk Fonden and Lundbeck Foundation. Personal fees from Eli Lilly, Celltrion, and Lundcbeck foundation, outside the submitted work. Castillo, Maria Guzman: Employee of MedEngine, which was contracted by Eli Lilly to conduct this study. Koivusalo, Mirkka: Employee of MedEngine, which was contracted by Eli Lilly to conduct this study. Loponen, Heidi: Employee of MedEngine, which was contracted by Eli Lilly to conduct this study. von Arx, Lill-Brith: Employee and shareholder of Eli Lilly and Company Adler Würtzen, Peter: Employee and shareholder of Eli Lilly and Company Gittens, Beatrice: Employee and shareholder of Eli Lilly and Company Poulsen, Anja: Writing support: Eli Lilly Consulting fees: Janssen, Bristol Myers Squibb, and Agomab Payments/honoraria: Janssen, Janssen Research & Development, Takeda, Eli Lilly, Tillots, Abbvie, MSD, and Bristol Myers Squibb Travel/meeting support: Janssen, Takeda, Eli Lilly, Tillots, and Abbvie Advisory board: Bristol Myers Squibb, Janssen, Takeda, Eli Lilly, Boehringer Ingelheim, Abbvie, Agomab
Larsen et al. (Thu,) studied this question.