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Living with ulcerative colitis in Germany: a retrospective analysis of dose escalation,concomitant treatment use and healthcare costs
Authors:Axel Dignass  John Waller  Joseph C. Cappelleri  Irene Modesto  Agnes Kisser  Lena Dietz
Affiliation:1. Agaplesion Markus Hospital, Frankfurt/Main, Germany;2. Adelphi Real World, Bollington, UK;3. Pfizer Inc, Groton, USA;4. Pfizer Inc, New York, USA;5. Pfizer Germany GmbH, Berlin, Germany
Abstract:Abstract

Aims: To investigate treatment of moderate-to-severe ulcerative colitis (UC) using real-world German health insurance claims data.

Materials and methods: A retrospective, longitudinal cohort study was conducted from a German statutory health insurance database for adult patients with UC indexed on biologic therapy initiation (2013–2015). Anonymized data were evaluated for 12?months prior to (baseline) through 24?months after (follow-up) indexing. Biologic dose escalations, steroid and immunosuppressant use, healthcare resource utilization (HCRU) and direct healthcare costs were evaluated, with significant differences assessed across and between index biologics. Descriptive statistics, chi-square or Fisher’s exact tests, and analysis of variance were performed.

Results: The analysis included 304 patients (adalimumab, n?=?125; golimumab, n?=?47; infliximab, n?=?114; vedolizumab, n?=?18). Demographic and clinical characteristics were similar across biologics. Dose escalations occurred in 58% of patients (73% of patients receiving adalimumab), with 41% receiving subsequent de-escalation. Steroids were used during follow-up by 74% of patients; 25% received steroids >14?weeks after indexing. Overall, 41% of patients received an immunosuppressant during follow-up. Steroid and immunosuppressant use were similar across biologics. Total direct healthcare costs were higher during follow-up than baseline and differed significantly across treatments (p?Limitations: There was potential for inappropriate inclusion/exclusion due to miscoding. Patients may have received biologics >12?months prior to the index date. Biologic originators and biosimilars could not be differentiated.

Conclusions: These data suggest that control with current biologics is suboptimal. Further treatment options that provide sustained steroid-free remission for this patient population without the need for dose escalations or concomitant therapies may be warranted.
Keywords:Biologics  claims data  direct healthcare costs  dose escalation  healthcare resource utilization  immunosuppressants  observational  real-world  steroids  ulcerative colitis
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