IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Piotr Wiland, Charlotte Both, Norman B Gaylis, Russell D Cohen, Jonas Halfvarson, Lena Lemke, Oliver von Richter, Andrew Blauvelt
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引用次数: 0

摘要

Sandoz-阿达木单抗(SDZ-ADL;Hyrimoz®,GP2017)是一种阿达木单抗(ADL)生物类似药,已被批准用于治疗免疫介导的炎症性疾病。在此,我们回顾了有关 SDZ-ADL 的对照研究和实际证据研究的现有文献。通过文献检索,我们找到了截至 2023 年 7 月发表的报道 SDZ-ADL 疗效、安全性、免疫原性和治疗保留率数据的文章。在随机临床试验中,SDZ-ADL的疗效、安全性和免疫原性与参考阿达木单抗(ref-ADL)的疗效、安全性和免疫原性相当,并且在单次或多次换药后均无改变。真实世界的研究证实,使用SDZ-ADL开始治疗以及从ref-ADL或其他ADL生物仿制药转用SDZ-ADL都是有效和安全的。这篇文献综述提供了证据,证明 SDZ-ADL 与 ref-ADL 相比,对于没有生物制剂治疗经验的患者和有生物制剂治疗经验的患者都同样有效和安全。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy, Safety, and Immunogenicity of SDZ-ADL, an Adalimumab Biosimilar, in Biologic-Naïve and Switched Patients with Immune-Mediated Inflammatory Diseases: A Literature Review.

Sandoz-adalimumab (SDZ-ADL; Hyrimoz®, GP2017) is an adalimumab (ADL) biosimilar approved for the treatment of immune-mediated inflammatory diseases. Here, we review the available literature on SDZ-ADL from controlled and real-world evidence studies. A literature search was carried out to identify articles published up to July 2023 reporting data on efficacy, safety, immunogenicity, and treatment retention rates for SDZ-ADL. In randomized clinical trials, the efficacy, safety, and immunogenicity of SDZ-ADL were comparable to those observed for reference-adalimumab (ref-ADL) and not altered after single or multiple drug switches. Real-world studies confirmed the effectiveness and safety of treatment initiation with SDZ-ADL and of switching to SDZ-ADL from ref-ADL or from other ADL biosimilars. This literature review provides evidence that SDZ-ADL is as effective and safe as ref-ADL in both biologic-naïve and biologic-experienced patients.

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来源期刊
Advances in Therapy
Advances in Therapy 医学-药学
CiteScore
7.20
自引率
2.60%
发文量
353
审稿时长
6-12 weeks
期刊介绍: Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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