Background The treatment landscape for active ulcerative colitis (UC) is rapidly evolving and current real-world evidence on response to advanced therapy is limited. This study aimed to determine indicators of inadequate therapeutic response among patients with UC in Germany initiating advanced therapy.

Methods This retrospective analysis used German claims data (2015-2022) from adult patients (≥18 years). Prevalence and incidence of UC (ICD-10-GM: K51.X) were estimated. Inadequate response to therapy was evaluated in patients initiating advanced therapy based on eight predefined indicators observed for 12 months following index treatment prescription.

Results Mean UC patient age in 2016-2022 ranged from 49.6 to 51.5 years, 47.6%-48.3% were female. Administrative prevalence ranged from 0.45% in 2016 to 0.53% in 2022. Number of patients initiating advanced treatment ranged from 157 to 347 across the study years (3.2%-4.9% of overall treated study population). On average from 2016-2021, 78.8% had inadequate response in the 12 months following index treatment. Common indicators included prolonged use of corticosteroids (46.2%) and augmentation with conventional therapies (43.9%).

Conclusions Adult UC patients showed a high prevalence of inadequate response to advanced therapies. Our findings reveal a need for improved UC advanced therapy options, providing insight into inadequate response patterns. This may help identify patients who could benefit from a change in therapy to improve long-term outcomes.

Carolina Schwedhelm, Leonie Berger, Nataliia Kulchytska, Ivonne Haensel, and Agnes Kisser are employed by Pfizer Pharma GmbH in Germany. Katrin Strassen, Sophie Marquardt, Anna Seiffert, and Alexa Benson are employees of Gesundheitsforen Leipzig GmbH, which is a paid consultant of Pfizer Pharma GmbH for designing the study, carrying out the analyses, and interpreting the results. Irina Blumenstein reports consulting and lecturer fees from AbbVie, Amgen, Biogen, Janssen-Cilag, Celgene/BMS GmbH, Celltrion, Falk Foundation, Fresenius Kabi, Galapagos, Lilly, Merck, Pharmacosmos, Pfizer, Takeda, Tillotts. Axel Dignass reports received fees for participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees from Abivax, AbbVie, Bristol Myers Squibb, Dr Falk Foundation, Galapagos, Gilead, Janssen, and Pfizer; consultancy fees from AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Dr Falk Foundation, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Roche, Sandoz, Stada, Takeda, Tillotts, and Vifor Pharma; payment for lectures including service on speakers bureaus from AbbVie, Biogen, CED Service GmbH, Celltrion, Falk Foundation, Ferring, Galapagos, Gilead, High5MD, Janssen, Materia Prima, MedToday, MSD, Pfizer, Sandoz, Takeda, Tillotts, and Vifor Pharma; payment for manuscript preparation from Abbvie, Falk Foundation, Janssen, Takeda, Thieme, and UniMed Verlag.

This study was funded by Pfizer Pharma GmbH. The funding organization provided financial support for the design, data collection, analysis, and interpretation of the study data.

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