Inadequate Response to Therapy Among Ulcerative Colitis Patients Initiating an Advanced Therapy: A Retrospective Analysis of German Health Claims Data

Author(s)

Schwedhelm C1, Berger L2, Marquardt S3, Strassen K3, Kulchytska N2, Hänsel I2, Seiffert A3, Blumenstein I4, Dignass A5, Kisser A2
1Pfizer Pharma GmbH, Berlin, BE, Germany, 2Pfizer Pharma GmbH, Berlin, Berlin, Germany, 3Gesundheitsforen Leipzig GmbH, Leipzig, Saxony, Germany, 4Goethe University Frankfurt, Frankfurt, Hesse, Germany, 5Agaplesion Markus Hospital, Frankfurt, Hesse, Germany

OBJECTIVES: High treatment failure rates among patients with active ulcerative colitis (UC) indicate a need to identify patients for whom a new advanced therapy may improve clinical prognosis. The aim of this study was to identify and quantify adult UC patients who show inadequate response to their first advanced therapy in German health claims data.

METHODS: We used DADB German Statutory Health Insurances (SHI) claims data for years 2015-2022. Adults with at least 2 secondary diagnoses in 2 quarters within one calendar year or one inpatient primary diagnosis (ICD-10-GM: K51.X) were included. Exclusion criteria included diagnosis of Crohn’s disease, indeterminate colitis, or other indications for advanced therapy prior to UC treatment start. Patients were considered to initiate an advanced UC therapy, if in the 12 months prior there were no prescriptions (i.e., first advanced treatment), or if a different advanced therapy agent was prescribed (i.e., change of advanced treatment). Inadequate response to the index treatment was analysed based on 8 predefined criteria observed during the 12 months following the prescription. Population sizes were quantified and extrapolated to the SHI-insured population.

RESULTS: During 2021, 347 patients received their first advanced treatment and 54 patients changed to another advanced treatment, corresponding to 8,499 and 1,278, extrapolated to the SHI population. Among patients initiating the first advanced treatment, the most common sign of inadequate response for index treatments in 2021 was prolonged use of corticosteroids (42.9%), followed by therapy discontinuation (36.9%). Overall, 71.2% of patients met at least 1 criterium of inadequate response, 48.9% at least 2 criteria, and 25.7% at least 3 criteria.

CONCLUSIONS: Our findings reveal a need in Germany for advanced UC therapy options and provide a better understanding of patterns of inadequate response to UC therapy that can help identify patients for whom a change of therapy may improve long-term outcome.

Conference/Value in Health Info

2024-11, ISPOR Europe 2024, Barcelona, Spain

Value in Health, Volume 27, Issue 12, S2 (December 2024)

Code

EPH132

Topic

Epidemiology & Public Health, Study Approaches

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Biologics & Biosimilars, Gastrointestinal Disorders

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