Impact of switching from the originator adalimumab to a biosimilar: a retrospective cohort study

Abstract Introduction Adalimumab is a monoclonal antibody that is used to treat autoimmune and inflammatory diseases. Biosimilars for adalimumab, including Hyrimoz, have been developed. We aimed to evaluate the effectiveness and adverse effects of Hyrimoz after switching. Methods The cohort consiste...

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Main Authors: W. H. A. van Poecke, N. E. F. Hooi, T. K. Mossel, M. A. W. Hermans, P. L. A. van Daele, E. M. Bunnik, Z. Brkic, L. K. Sels, A. A. H. J. Thiadens, P. M. van Hagen, J. A. M. van Laar, S. M. Rombach
Format: Article
Language:English
Published: BMC 2025-07-01
Series:BMC Immunology
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Online Access:https://doi.org/10.1186/s12865-025-00693-9
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author W. H. A. van Poecke
N. E. F. Hooi
T. K. Mossel
M. A. W. Hermans
P. L. A. van Daele
E. M. Bunnik
Z. Brkic
L. K. Sels
A. A. H. J. Thiadens
P. M. van Hagen
J. A. M. van Laar
S. M. Rombach
author_facet W. H. A. van Poecke
N. E. F. Hooi
T. K. Mossel
M. A. W. Hermans
P. L. A. van Daele
E. M. Bunnik
Z. Brkic
L. K. Sels
A. A. H. J. Thiadens
P. M. van Hagen
J. A. M. van Laar
S. M. Rombach
author_sort W. H. A. van Poecke
collection DOAJ
description Abstract Introduction Adalimumab is a monoclonal antibody that is used to treat autoimmune and inflammatory diseases. Biosimilars for adalimumab, including Hyrimoz, have been developed. We aimed to evaluate the effectiveness and adverse effects of Hyrimoz after switching. Methods The cohort consisted of patients treated with adalimumab at the Clinical Immunology Outpatient Department of the Erasmus Medical Center between February 2021 and February 2023. Data were collected through electronic patient files and questionnaires sent to the patients. The primary outcome was the number of flares after switching to Hyrimoz, compared to a similar period before the switch. The secondary outcomes were reported adverse effects and patient experience using Hyrimoz. Results A total of 185 patients were eligible for inclusion. There was no significant difference in the occurrence of flares between Humira and Hyrimoz (P = 0.456). Forty-six of the 185 patients reported adverse effects (24.9%). A total of 25/185 (13.5%) patients reported pain during injection, which was the most frequently reported adverse effect. During the course of this study, 60/185 (32.4%) patients discontinued Hyrimoz treatment because of flares (n = 17 [9.2%]), adverse effects (n = 27 [14.6%]), or more subjective complaints (n = 15 [8.1%]) related to the underlying disease. One patient discontinued treatment because of inactive disease. Conclusion The number of flares before and after switching to Hyrimoz was comparable. However, adverse effects and increased subjective complaints have been reported after switching to this new biosimilar.
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spelling doaj-art-0cbcdcbbf49d4d2abc51ee5d01b2c6b02025-08-20T04:01:26ZengBMCBMC Immunology1471-21722025-07-0126111310.1186/s12865-025-00693-9Impact of switching from the originator adalimumab to a biosimilar: a retrospective cohort studyW. H. A. van Poecke0N. E. F. Hooi1T. K. Mossel2M. A. W. Hermans3P. L. A. van Daele4E. M. Bunnik5Z. Brkic6L. K. Sels7A. A. H. J. Thiadens8P. M. van Hagen9J. A. M. van Laar10S. M. Rombach11Department of Internal Medicine, Allergy and Clinical Immunology, Erasmus MC University Medical CenterDepartment of Pharmacy, Erasmus MC University Medical CenterDepartment of Pharmacy, Erasmus MC University Medical CenterDepartment of Internal Medicine, Allergy and Clinical Immunology, Erasmus MC University Medical CenterDepartment of Internal Medicine, Allergy and Clinical Immunology, Erasmus MC University Medical CenterDepartment of Medical Ethics, Philosophy, and History of Medicine, Erasmus MCDepartment of Internal Medicine, Allergy and Clinical Immunology, Erasmus MC University Medical CenterDepartment of Ophthalmology, Erasmus MC University Medical CenterDepartment of Ophthalmology, Erasmus MC University Medical CenterDepartment of Internal Medicine, Allergy and Clinical Immunology, Erasmus MC University Medical CenterDepartment of Internal Medicine, Allergy and Clinical Immunology, Erasmus MC University Medical CenterDepartment of Internal Medicine, Allergy and Clinical Immunology, Erasmus MC University Medical CenterAbstract Introduction Adalimumab is a monoclonal antibody that is used to treat autoimmune and inflammatory diseases. Biosimilars for adalimumab, including Hyrimoz, have been developed. We aimed to evaluate the effectiveness and adverse effects of Hyrimoz after switching. Methods The cohort consisted of patients treated with adalimumab at the Clinical Immunology Outpatient Department of the Erasmus Medical Center between February 2021 and February 2023. Data were collected through electronic patient files and questionnaires sent to the patients. The primary outcome was the number of flares after switching to Hyrimoz, compared to a similar period before the switch. The secondary outcomes were reported adverse effects and patient experience using Hyrimoz. Results A total of 185 patients were eligible for inclusion. There was no significant difference in the occurrence of flares between Humira and Hyrimoz (P = 0.456). Forty-six of the 185 patients reported adverse effects (24.9%). A total of 25/185 (13.5%) patients reported pain during injection, which was the most frequently reported adverse effect. During the course of this study, 60/185 (32.4%) patients discontinued Hyrimoz treatment because of flares (n = 17 [9.2%]), adverse effects (n = 27 [14.6%]), or more subjective complaints (n = 15 [8.1%]) related to the underlying disease. One patient discontinued treatment because of inactive disease. Conclusion The number of flares before and after switching to Hyrimoz was comparable. However, adverse effects and increased subjective complaints have been reported after switching to this new biosimilar.https://doi.org/10.1186/s12865-025-00693-9Flareadverse effectsbiosimilaradalimumabHyrimozHumira
spellingShingle W. H. A. van Poecke
N. E. F. Hooi
T. K. Mossel
M. A. W. Hermans
P. L. A. van Daele
E. M. Bunnik
Z. Brkic
L. K. Sels
A. A. H. J. Thiadens
P. M. van Hagen
J. A. M. van Laar
S. M. Rombach
Impact of switching from the originator adalimumab to a biosimilar: a retrospective cohort study
BMC Immunology
Flare
adverse effects
biosimilar
adalimumab
Hyrimoz
Humira
title Impact of switching from the originator adalimumab to a biosimilar: a retrospective cohort study
title_full Impact of switching from the originator adalimumab to a biosimilar: a retrospective cohort study
title_fullStr Impact of switching from the originator adalimumab to a biosimilar: a retrospective cohort study
title_full_unstemmed Impact of switching from the originator adalimumab to a biosimilar: a retrospective cohort study
title_short Impact of switching from the originator adalimumab to a biosimilar: a retrospective cohort study
title_sort impact of switching from the originator adalimumab to a biosimilar a retrospective cohort study
topic Flare
adverse effects
biosimilar
adalimumab
Hyrimoz
Humira
url https://doi.org/10.1186/s12865-025-00693-9
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