¹Agaplesion Markus Hospital, Department of Medicine I, Frankfurt am Main, Germany
²Goethe University Frankfurt, University Hospital, Medical Clinic 1, Frankfurt am Main, Germany
³Pfizer Pharma GmbH, Berlin, Germany
⁴Gesundheitsforen Leipzig GmbH, Leipzig, Germany

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Introduction: Ulcerative colitis (UC) is a chronic inflammatory bowel disease that causes significant morbidity and impaired quality of life [1]. In Germany, approximately 5.3 per 1,000 adults are affected [2]. Recent studies showed that most adult patients initiating advanced therapy (72-82%) exhibit an inadequate response (IR) [2], [3]. This study builds on the previous research to evaluate healthcare resource utilization (HCRU) and medical costs among adult UC patients with and without IR to their first advanced therapy.

Methods: This non-interventional, retrospective study used claims data from the German Analysis Database for Evaluation and Health Services Research (DADB) – managed by Gesundheitsforen Leipzig GmbH – assessed adult UC patients initiating their first advanced treatment between 2016 and 2021. The DADB includes data from 15 statutory health insurers and is representative in terms of age and sex of the broader German population. IR to therapy was defined as exhibiting ≥ 1 of 8 predefined criteria (i.e., dose escalation, therapy switch, augmentation with conventional therapy, prolonged use of corticosteroids, therapy discontinuation, UC-related surgery, UC-related hospitalization, anti-diarrheal prescriptions) during the 12 months following prescription [2]. HCRU and direct medical costs were calculated for outpatient and inpatient care and medication.

Results: In 2021, 334 UC patients initiated advanced treatment, among which 239 (72%) exhibited IR [2]. Overall visits to general practitioners (GP), gastroenterologists, and other specialists were on average 5.3, 3.8, and 11.9 times per patient, respectively. Most of all GP visits (72.2%) and gastroenterologist visits (81.6%) were UC-related, compared to only 19.3% of other specialist visits. Number of and costs for outpatient visits were similar among patients with and without IR. The main cost burden was attributable to medication. Patients with IR had on average a higher number of all-cause and UC-related prescriptions than patients without IR (35 vs 22 all cause; 15 vs 10 UC-related). Accordingly, medication costs were higher in patients with IR (25,002€ vs 21,713€ all-cause; 19,516€ vs 18,643€ UC-related). 86 (26%) patients had ≥ 1 hospitalization, of which 29 (34%) had ≥ 1 UC-related hospitalization. Patients with IR had on average more (1.6 vs 1.0) and longer (10.1 vs 2.7 days) all-cause hospitalizations than patients without IR. Due to the IR definition, all patients with UC-related hospitalizations were in the IR cohort, with an average of 1.7 hospitalizations, each lasting on average 16.4 days. Mean costs for inpatient care were higher for hospitalized IR patients compared to hospitalized patients without IR (€10,242 vs €2,220 all-cause; €12,562 UC-related). While mean number of hospitalizations remained stable across the study years (2016-2021), the mean duration and costs for inpatient care increased.

Conclusion: Patients with IR to UC advanced therapy had 59% more medication prescriptions, 60% higher hospitalization rates and hospital stays that were nearly triple in length (274%), leading to increased outpatient and inpatient costs. Ensuring adequate treatment response is crucial to minimizing unnecessary hospitalizations and medical costs. Further research focusing on identifying predictive factors for IR and evaluating alternative treatment strategies is needed to improve patient outcomes and reduce burden on healthcare systems.

This study was funded by Pfizer. Carolina Schwedhelm, Leonie Kunk, Nataliia Kulchytska, and Agnes Kisser are employed by Pfizer Pharma GmbH in Germany. Sophie Marquardt, Katrin Strassen, 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, J&J, and Pfizer; consultancy fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Dr Falk Foundation, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, J&J, 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, J&J, Materia Prima, MedToday, MSD, Pfizer, Sandoz, Takeda, Tillotts, and Vifor Pharma; payment for manuscript preparation from Abbvie, Falk Foundation, J&J, Takeda, Thieme, and UniMed Verlag.

The authors declare that an ethics committee vote is not required.

References

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