Anti-TNF dose escalation and drug sustainability in Crohn's disease: Data from the nationwide administrative database in Hungary

Background: A significant percentage of patients receiving anti-tumor necrosis factor alpha (anti-TNF alpha) agents lose clinical response over time. This study aims to provide representative real-world data on anti-TNF alpha drug sustainability, prevalence and predictors of anti-TNF alpha dose escalation. Methods: In this nationwide, retrospective study, patients receiving infliximab or adalimumab therapy between 2013 and 2016 were included using the administrative claims database of the Hungarian National Health Insurance Fund. Demographic characteristics, drug sustainability, dose escalation, use of parallel medications were analyzed. Results: 476 infliximab and 397 adalimumab patients were included. Dose escalation was observed in 7%, 9% and 22% of patients receiving originator/biosimilar infliximab and adalimumab during the complete follow-up, respectively. Dose escalation was associated with shorter disease duration (OR = 1.75, p = 0.026) and corticosteroid use. Drug retention rates were 62.7%, 72.3%, 75.4% after 1 year follow-up for Remicade (R), Inflectra (R) and Humira (R), which decreased to 38.3% and 52.1% for Remicade (R) and Humira (R) at 3 years. Drug sustainability was affected by steroid use prior biologic initiation in adalimumab treated patients (HR = 2.04, p < 0.001), while in infliximab treated patients dose escalation (HR = 0.51, p = 0.02) and gender (HR = 1.39, p = 0.033) were predictors of treatment discontinuation. Conclusion: Dose escalation rates were lower in this real-world administrative database study for both adalimumab and infliximab compared to published data. Drug retention rates were overall satisfactory, with no apparent difference between the legacy and biosimilar infliximab. (C) 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.