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

Fruzsina Kósa, Péter Kunovszki, András Borsi, Ákos Iliás, Károly Palatka, Tamás Szamosi, Áron Vincze, Tamás Molnár, Peter L. Lakatos

Research output: Article

Abstract

Background: A significant percentage of patients receiving anti-tumor necrosis factor alpha (anti-TNFα) agents lose clinical response over time. This study aims to provide representative real-world data on anti-TNFα drug sustainability, prevalence and predictors of anti-TNFα 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®, Inflectra® and Humira®, which decreased to 38.3% and 52.1% for Remicade® and Humira® 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.

Original languageEnglish
JournalDigestive and Liver Disease
DOIs
Publication statusAccepted/In press - jan. 1 2019

Fingerprint

Hungary
Crohn Disease
Databases
Biosimilar Pharmaceuticals
Pharmaceutical Preparations
Tumor Necrosis Factor-alpha
Infliximab
National Health Programs
Adalimumab
Adrenal Cortex Hormones
Retrospective Studies
Steroids
Demography
Therapeutics

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

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title = "Anti-TNF dose escalation and drug sustainability in Crohn's disease: Data from the nationwide administrative database in Hungary",
abstract = "Background: A significant percentage of patients receiving anti-tumor necrosis factor alpha (anti-TNFα) agents lose clinical response over time. This study aims to provide representative real-world data on anti-TNFα drug sustainability, prevalence and predictors of anti-TNFα 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{\circledR}, Inflectra{\circledR} and Humira{\circledR}, which decreased to 38.3{\%} and 52.1{\%} for Remicade{\circledR} and Humira{\circledR} 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.",
keywords = "Adalimumab, Crohn's disease, Dose-escalation, Drug sustainability, Infliximab",
author = "Fruzsina K{\'o}sa and P{\'e}ter Kunovszki and Andr{\'a}s Borsi and {\'A}kos Ili{\'a}s and K{\'a}roly Palatka and Tam{\'a}s Szamosi and {\'A}ron Vincze and Tam{\'a}s Moln{\'a}r and Lakatos, {Peter L.}",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.dld.2019.09.020",
language = "English",
journal = "Digestive and Liver Disease",
issn = "1590-8658",
publisher = "Elsevier",

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TY - JOUR

T1 - Anti-TNF dose escalation and drug sustainability in Crohn's disease

T2 - Data from the nationwide administrative database in Hungary

AU - Kósa, Fruzsina

AU - Kunovszki, Péter

AU - Borsi, András

AU - Iliás, Ákos

AU - Palatka, Károly

AU - Szamosi, Tamás

AU - Vincze, Áron

AU - Molnár, Tamás

AU - Lakatos, Peter L.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: A significant percentage of patients receiving anti-tumor necrosis factor alpha (anti-TNFα) agents lose clinical response over time. This study aims to provide representative real-world data on anti-TNFα drug sustainability, prevalence and predictors of anti-TNFα 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®, Inflectra® and Humira®, which decreased to 38.3% and 52.1% for Remicade® and Humira® 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.

AB - Background: A significant percentage of patients receiving anti-tumor necrosis factor alpha (anti-TNFα) agents lose clinical response over time. This study aims to provide representative real-world data on anti-TNFα drug sustainability, prevalence and predictors of anti-TNFα 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®, Inflectra® and Humira®, which decreased to 38.3% and 52.1% for Remicade® and Humira® 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.

KW - Adalimumab

KW - Crohn's disease

KW - Dose-escalation

KW - Drug sustainability

KW - Infliximab

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