阿达木单抗生物仿制药GP2017在斑块型银屑病24个月治疗期的疗效和安全性:来自意大利艾米利亚-罗马涅中心的真实经验

IF 1.3 Q2 DERMATOLOGY
Marco May Lee, Vito Di Lernia, Francesca Peccerillo, Federico Bardazzi, Michela Tabanelli, Michela Ricci, Davide Melandri, Monica Corazza, Francesca Satolli, Andrea Conti
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引用次数: 0

摘要

阿达木单抗(ADA)是一种靶向TNF-α的单克隆抗体,可有效治疗中度至重度牛皮癣。GP2017 (Hyrimoz®)等生物仿制药的出现引发了人们对其安全性和有效性的担忧。这项为期两年的观察性研究评估了GP2017在意大利艾米利亚-罗马涅171名患者中的有效性和安全性。患者分为两组:78例从ADA始发者过渡到ADA, 93例为生物学新手。分析银屑病面积和严重程度指数(PASI)的变化。在转换组,PASI评分保持稳定,而初始组取得了显著改善(PASI 75: 3个月时52%,6个月时89%)。导致停药的不良事件很少。研究结果证实,GP2017与ADA原药一样有效和安全,支持其作为治疗牛皮癣的一种具有成本效益的替代方案。生物仿制药在促进公平获得生物疗法方面发挥着至关重要的作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of adalimumab biosimilar GP2017 in a 24-month treatment period for plaque psoriasis: real-life experience from Emilia-Romagna centers, Italy.

Adalimumab (ADA), a monoclonal antibody targeting TNF-α, is effective in treating moderate to severe psoriasis. The emergence of biosimilars, such as GP2017 (Hyrimoz®), has raised concerns about their safety and efficacy compared to the originator. This two-year observational study evaluated the effectiveness and safety of GP2017 in 171 patients from Emilia-Romagna, Italy. Patients were divided into two groups: 78 transitioned from the ADA originator, and 93 were biologic-naive. Changes in the Psoriasis Area and Severity Index (PASI) were analyzed. In the switch group, PASI scores remained stable, while the naive group achieved significant improvements (PASI 75: 52% at 3 months, 89% at 6 months). Adverse events leading to discontinuation were rare. The findings confirm that GP2017 is as effective and safe as the ADA originator, supporting its use as a cost-effective alternative in the treatment of psoriasis. Biosimilars play a crucial role in promoting equitable access to biologic therapies.

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来源期刊
Dermatology Reports
Dermatology Reports DERMATOLOGY-
CiteScore
1.40
自引率
0.00%
发文量
74
审稿时长
10 weeks
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