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从原研阿达木单抗转换为生物类似药的影响:一项回顾性队列研究。

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

作者信息

van Poecke W H A, Hooi N E F, Mossel T K, Hermans M A W, van Daele P L A, Bunnik E M, Brkic Z, Sels L K, Thiadens A A H J, van Hagen P M, van Laar J A M, Rombach S M

机构信息

Department of Internal Medicine, Allergy and Clinical Immunology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.

Department of Pharmacy, Erasmus MC University Medical Center, Rotterdam, the Netherlands.

出版信息

BMC Immunol. 2025 Jul 3;26(1):44. doi: 10.1186/s12865-025-00693-9.

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.

摘要

引言

阿达木单抗是一种用于治疗自身免疫性和炎性疾病的单克隆抗体。已开发出包括Hyrimoz在内的阿达木单抗生物类似药。我们旨在评估换药后Hyrimoz的有效性和不良反应。

方法

该队列由2021年2月至2023年2月在伊拉斯姆斯医学中心临床免疫门诊接受阿达木单抗治疗的患者组成。数据通过电子病历和发送给患者的问卷收集。主要结局是换药至Hyrimoz后发作次数,与换药前的相似时期进行比较。次要结局是报告的不良反应和患者使用Hyrimoz的体验。

结果

共有185例患者符合纳入标准。修美乐和Hyrimoz之间发作的发生率无显著差异(P = 0.456)。185例患者中有46例报告了不良反应(24.9%)。共有25/185(13.5%)例患者报告注射时疼痛,这是报告最频繁的不良反应。在本研究过程中,60/185(32.4%)例患者因发作(n = 17 [9.2%])、不良反应(n = 27 [14.6%])或与基础疾病相关的更多主观症状(n = 15 [8.1%])而停用Hyrimoz治疗。1例患者因疾病不活动而停药。

结论

换药至Hyrimoz前后发作次数相当。然而,换药至这种新的生物类似药后报告了不良反应和主观症状增加。

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