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从阿达木单抗原研药转换为生物类似药治疗化脓性汗腺炎:除了成本效益之外还有什么?

Switching from adalimumab originator to biosimilars in hidradenitis suppurativa: What's beyond cost-effectiveness?

机构信息

Department of Medical Sciences, Section of Dermatology, University of Turin, Turin, Italy.

出版信息

Dermatol Ther. 2022 Nov;35(11):e15803. doi: 10.1111/dth.15803. Epub 2022 Sep 14.

Abstract

In the last years, adalimumab biosimilars have represented a commonly used alternative to the originator agent in the treatment of moderate to severe hidradenitis suppurativa. As of today, studies investigating the switch from adalimumab originator to biosimilar, following pharmacoeconomic policies, are lacking. Herein we present a real-life setting retrospective study aimed at assessing the safety and efficacy of this switch in 37 patients, evaluated for 12 months in terms of IHS4 (International Hidradenitis Suppurativa Severity Score System) and HiSCR (Hidradenitis Suppurativa Clinical Response). Overall, no significant differences emerge between adalimumab originator and biosimilar in terms of clinical response following non-medical switch. High discontinuation rates (43.2%) raise questions on patients' compliance to the new drug regimen, as severe pain at the injection site represents a substantial cause of biosimilar discontinuation (i.e., 31.5% of the cases). In selected cases, rechallenge with adalimumab originator may represent a valid option, as 66.6% (n = 8) of the patients who switched back to the former agent have benefited in terms of tolerability and efficacy. Carefully integrating pharmacoeconomic policies with a thorough assessment regarding the benefit-risk ratio of a nonmedical switch from originator to biosimilars remains essential to provide each HS patient with the best therapeutic option.

摘要

在过去的几年中,阿达木单抗生物类似药已成为治疗中重度化脓性汗腺炎的常用替代药物。迄今为止,根据药物经济学政策,尚缺乏研究阿达木单抗原研药与生物类似药转换的研究。在此,我们开展了一项真实世界的回顾性研究,旨在评估 37 例患者转换后的安全性和疗效,这些患者在 12 个月内通过 IHS4(国际化脓性汗腺炎严重程度评分系统)和 HiSCR(化脓性汗腺炎临床反应评分)进行评估。总体而言,非医疗转换后,在临床反应方面,阿达木单抗原研药和生物类似药之间没有显著差异。较高的停药率(43.2%)对患者对新药物方案的依从性提出了质疑,因为注射部位的严重疼痛是导致生物类似药停药的一个重要原因(即 31.5%的病例)。在某些情况下,重新使用阿达木单抗原研药可能是一种有效的选择,因为在重新转换回原药的 66.6%(n=8)的患者中,在耐受性和疗效方面均有获益。仔细将药物经济学政策与非医疗转换的获益-风险比进行综合评估,对于为每位 HS 患者提供最佳治疗方案仍然至关重要。

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