Rate of adverse events and associated health care costs for the management of inflammatory bowel disease in Germany.

Abstract

PURPOSE\nTherapeutic management of inflammatory bowel disease (IBD) is challenging, and available therapies are associated with adverse events (AEs) that may lead to treatment discontinuation. This study evaluated the rate of drug-related AEs of special interest (AESIs) associated with IBD therapies and compare health care costs among patients with IBD who did and did not experience AESIs.\n\n\nMETHODS\nA retrospective cohort analysis was conducted using claims data from a German Sickness Fund (Allgemeine Ortskrankenkasse PLUS). Patients were diagnosed with ulcerative colitis (UC) or Crohn s disease (CD) and newly initiating treatment with immunosuppressant, anti-tumor necrosis factor α, or anti-integrin therapies from January 1, 2011, to December 31, 2015. Patients were required to have continuous insurance coverage and no evidence of use of these IBD therapies for 12 months before the date of newly initiating therapy (index date). Rates of AESIs were based on 28 different events or chronic conditions associated with IBD treatment. Direct health care costs were reported separately for patients who did or did not experience AESIs. Only treatment periods lasting ≥60 days were considered. AESI rates related to all possible treatment patterns were calculated and reported as the number of events per 10,000 patient-years. Health care costs were calculated based on IBD-related health care resource use.\n\n\nFINDINGS\nA total of 1126 (CD, n\xa0=\xa0676; UC, n\xa0=\xa0450) patients met the inclusion criteria. Mean age was 36.5 years for patients with CD and 42.5 years for patients with UC; 60.5% and 47.6% were female, respectively. Median observed time since the index date was 1460 and 1552 days, for patients with CD and UC. The overall rate for any AESI was 1392.4 and 1917.9 events per 10,000 patient-years in patients with CD and those with UC. Severe infections and diabetes mellitus were the most common AESIs. Significant differences in mean total direct health care costs were found for CD patients with AESIs versus those without (€8920.08 and €6004.86; P\xa0<\xa00.001). A similar trend was observed with mean drug costs and mean medical costs. In UC, total direct health care costs, although generally higher in patients with AESIs, were not significantly different; however, medical costs were (€1946.93 vs €971.28; P\xa0<\xa00.001).\n\n\nIMPLICATIONS\nAEs are common in patients with IBD treated with current therapies and associated with substantial health care costs. An urgent need exists for development of IBD treatments that are associated with lower rates of AEs. (Clin Ther. 2019;41:XXX-XXX) © 2019 Elsevier HS Journals, Inc.