Efficacy and safety of adalimumab biosimilar GP2017 in a 24-month treatment period for plaque psoriasis: real-life experience from Emilia-Romagna centers, Italy.

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
{"title":"Efficacy and safety of adalimumab biosimilar GP2017 in a 24-month treatment period for plaque psoriasis: real-life experience from Emilia-Romagna centers, Italy.","authors":"Marco May Lee, Vito Di Lernia, Francesca Peccerillo, Federico Bardazzi, Michela Tabanelli, Michela Ricci, Davide Melandri, Monica Corazza, Francesca Satolli, Andrea Conti","doi":"10.4081/dr.2025.10315","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11049,"journal":{"name":"Dermatology Reports","volume":" ","pages":""},"PeriodicalIF":1.3000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology Reports","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4081/dr.2025.10315","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

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.

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
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。
求助全文
约1分钟内获得全文 求助全文
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
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信