Abstract Background Mirikizumab is an anti-interleukin-23p19 (IL-23p19) IgG4 monoclonal antibody indicated for moderately to severely active ulcerative colitis (UC) and Crohn’s disease. Evidence from randomized clinical trials supports its efficacy and safety in UC. However, realworld data remains limited. To better understand real-world mirikizumab treatment persistence in a large cohort of patients (pts) with UC, we analyzed data from a German longitudinal prescription database (IQVIA™ LRx). Methods This retrospective observational study included adults (≥18 years) with a first mirikizumab infusion prescription between July 1, 2023, and March 31, 2024, and ≥12 months of continuous observation both before and after the index date (mirikizumab initiation). Prior UC treatments were assessed during a pre-period of up to 8 years before the index date; pts with a prior anti-IL-23p19 antibody prescription were excluded. The primary endpoint was 12-month treatment persistence, defined as continued mirikizumab treatment without a gap of 90 days after exhausting supply, estimated using the Kaplan-Meier method. Secondary endpoints included treatment persistence at 3, 6, and 9 months and subgroup analyses by number of prior advanced treatments. Results In total, 388 pts were included (43% female, mean age 46.7, with 26% aged 60 or older). The majority of pts (92%) had at least one prior advanced treatment and 52% had three or more (mean: 2.63). Prior utilization of conventional treatments was high. Among advanced treatments, most pts had previously received an integrin antagonist (70%) and TNF inhibitors (68%). The last advanced treatment prior to mirikizumab initiation was distributed across multiple classes (Table). Overall, the 12-month treatment persistence rate for mirikizumab was 62% (95% CI: 57%–66%); with rates of 89%, 77%, and 68% at 3, 6, and 9 months, respectively. Stratified 12-month treatment persistence rates by number of prior advanced treatments were highest in naïve pts (72%) and those with only one prior advanced treatment (71%). Persistence rates were 66% in pts with two prior advanced treatments and 58% in those with three or more (Figure). Conclusion In this extensively pre-treated German cohort, approximately 62% of pts remained on mirikizumab at 12 months. Treatment persistence exceeded 70% in advanced treatment-naïve pts and those with only one prior advanced treatment, and was 66% in pts with two prior advanced treatments. These findings provide insights into mirikizumab persistence in routine clinical practice and suggest its potential durability even in populations with a history of multiple advanced treatments. Conflict of interest: Blumenstein, Irina: Consulting and/or speker fees: AbbVie, Alfasigma, Amgen, Biogen, CED Service GmbH, Falk, Ferring, Fraunhofer, Johnson&Johnson, Pharmacosmos, Pfizer, Sanofi, Takeda, Tillotts Research grants: Fraunhofer ITMP, Sanofi Sturm, Andreas: I served as speaker or advisor for Abbvie, Alfasigma/Galapagos, Amgen, Biogen, BMS, Celltrion, Dr. Falk Pharma, Ferring, Hexal/Sandoz, Janssen-Cilag GmbH, Lilly, MSD, Mundipharm, Pfizer, Takeda, Tillots Rößler, Tatjana: Tatjana Rößler is an employee and minor shareholder of Eli Lilly and Company Maier, Sebastian: Employee and shareholder of Eli Lilly and Company Vadhariya, Aisha: Aisha Vadhariya is an employee and minor shareholder of Eli Lilly and Company. Monnard, Arnaud: Arnaud Monnard is an employee and minor shareholder of Eli Lilly and Company. Cai, Xinting: Xinting Cai is employee of IQVIA, which received funding from Lilly to conceptualize and conduct the analysis of the study. Alymova, Svetlana: Svetlana Alymova is employee of IQVIA, which received funding from Lilly to conceptualize and conduct the analysis of the study. Maaser, Christian: Speaker honaria and/or Advisory honaria Abbvie, Alfasigma, Biogen, Falk Foundation, Galapagos, Gilead, J&J, MSD Sharp & Dome, Pfizer, Roche, Samsung, Takeda Zeissig, Sebastian: Grant: Ardeypharm, Celltrion Healthcare Personal Fees: Advisory: Abbvie Deutschland GmbH, Amgen GmbH, Biogen GmbH, Bristol-Myers Squibb GmbH, Celltrion Healthcare, Ferring Arzneimittel GmbH, Hogg Robinson GmbH, Mylan, Janssen Cilag GmbH, Pfizer Pharma GmbH, Takeda Pharma GmbH. Speakers bureau: Abbvie Deutschland GmbH, Amgen GmbH, Biogen GmbH, Bristol-Myers Squibb GmbH, CED Service GmbH, Falk Foundation e.V., Ferring Arzneimittel GmbH, FORGA Solutions GmbH, GWT-TUD GmbH, Janssen Cilag GmbH, Janssen Pharmaceutica NV, MSD Sharp & Dome, Roche, Pfizer Pharma GmbH, Pharma Zentrale GmbH, Takeda Pharma GmbH, WebMD Global
Blumenstein et al. (Thu,) studied this question.