Real-world biologic treatment and associated cost in patients with inflammatory bowel disease.

Objectives  This study aimed to describe biologic treatment of German inflammatory bowel disease (IBD) patients, including biologics’ dosage, health care resource use, and treatment-associated cost. Methods  In this retrospective claims data analysis, all continuously insured adult IBD patients (Crohnʼs disease [CD] or ulcerative colitis [UC]) who started a new therapy with an anti-tumor necrosis factor alpha (anti-TNF-α) or vedolizumab (VDZ) were included. Observation started with the date of the first prescription of index biologic therapy and lasted 12 months. Results  In the database, 1248 out of 57 296 IBD patients started a biologic treatment of interest (1020 anti-TNF-α, 228 VDZ), and 837 patients were bio-naive (773 anti-TNF-α, 64 VDZ). The mean age of bio-naive/bio-experienced anti-TNF-α patients was 39.2/38.1 years (54.9 %/56.7 % female) and 42.6/37.8 years for VDZ patients (56.3 %/54.9 % female). The proportion of patients receiving a maintenance dosage > 150 % compared to SmPC was 15.1 % for Adalimumab, 5.2–39.0 % for Golimumab, 14.7–34.5 % for Infliximab, and 19.7 % for VDZ patients. During the maintenance phase, up to 58.8 % of patients received at least 1 prescription of any CS, and 41.7 %/47.1 % (anti-TNF-α/VDZ) were treated in a hospital due to IBD. The mean IBD-related direct health care cost per patient year was € 30 246 (anti-TNF-α)/ € 28 227 (VDZ) for bio-naive patients (p = 0.288) and € 34 136 (anti-TNF-α)/ € 32 112 (VDZ) for bio-experienced patients (p = 0.011). Conclusions  A substantial percentage of patients receive a high biologic dosage in the maintenance phase. Despite biologic therapy, 30–40 % receive a CS therapy and/or experience at least 1 IBD-associated hospitalization within a year, possibly indicating a remaining disease activity.