Real-world biologic treatment and associated cost in patients with inflammatory bowel disease^[*]

Abstract

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-naïve (773 anti-TNF-α, 64 VDZ). The mean age of bio-naïve/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-naïve 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.

Zusammenfassung

Fragestellung Ziel der Studie war die Beschreibung der Biologikatherapie von Patienten mit chronisch-entzündlichen Darmerkrankungen (CED) in Deutschland.

Methode Diese retrospektive Krankenkassendatenstudie adressierte erwachsene Patienten mit CED (Morbus Crohn (MC) oder Colitis ulcerosa (UC)), die eine neue Therapie mit anti-TNFα oder Vedolizumab (VDZ) starteten. Die Beobachtungszeit von 12 Monaten begann mit der ersten Verordnung der neuen Therapie.

Ergebnisse 1248 von insgesamt 57 296 CED Patienten starteten eine neue Biologikatherapie (1020 anti-TNFα; 228 VDZ), 837 waren bio-naiv (773 anti-TNFα/64 VDZ). Das mittlere Alter der bio-naiven/bio-erfahrenen anti-TNFα Patienten betrug 39,2/38,1 Jahre (54,9 %/56,7 % Frauen), das der VDZ-Patienten 42,6/37,8 Jahre (56,3 %/54,9 % Frauen). Im Vergleich zu Empfehlungen aus der Fachinformation haben 15,1 % der Patienten mit Adalimumab, 5,2–39,0 % derjenigen mit Golimumab, 14,7–34,5 % derjenigen mit Infliximab und 19,7 % der VDZ-Patienten eine Erhaltungsdosis von > 150 % erhalten. Während der Erhaltungsphase haben 58,8 % Kortikosteroide erhalten, 41,7 %/27,1 % (anti-TNFα/VDZ) wurden aufgrund der CED stationär behandelt. Die CED-bezogenen direkten Kosten pro Patientenjahr lagen im Durchschnitt bei 30 246 € (anti-TNFα) bzw. 28 227 € (VDZ) für bio-naive (p = 0,288) und 34 136 € (anti-TNFα) bzw. 32 112 € (VDZ) für bio-erfahrene Patienten (p = 0,011).

Schlussfolgerungen Während der Erhaltungsphase erhält ein erheblicher Anteil der CED-Patienten eine hohe Biologikadosis. Dennoch haben innerhalb eines Jahres 30–40 % der Patienten Kortikosteroide erhalten und/oder eine CED-bezogene Hospitalisierung erlebt, was auf eine bestehende Krankheitsaktivität hinweisen könnte.

Key words

inflammatory bowel disease (IBD) - biologic treatment - ulcerative colitis - Crohnʼs disease - hospitalization - maintenance therapy

Schlüsselwörter

Chronisch-entzündliche Darmerkrankungen (CED) - Biologikatherapie - Colitis ulcerosa (UC) - Morbus Crohn (MC) - Hospitalisierung - Erhaltungstherapie

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