Belimumab患者概况在西班牙:演变在过去十年和未来的方向。

IF 4 3区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
Expert Opinion on Biological Therapy Pub Date : 2025-04-01 Epub Date: 2025-03-20 DOI:10.1080/14712598.2025.2479018
Tarek Carlos Salman-Monte, María José Cuadrado, María Galindo, Gerard Espinosa, Enrique Morales, José María Pego-Reigosa, Lucio Pallarés, Covadonga López, Carmen San Román, Íñigo Rúa-Figueroa
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引用次数: 0

摘要

简介:Belimumab (BEL)是一种抗b淋巴细胞刺激剂单克隆抗体,是唯一被批准用于系统性红斑狼疮(SLE)和狼疮肾炎(LN)的生物疗法。涵盖领域:本综述讨论BEL在现实世界中的应用及其在临床实践指南中的定位,重点关注其应用的演变和过去十年在西班牙的患者概况。专家意见:BEL最初用于难治性、非主要的SLE表现,现已扩大应用范围。国际指南现在建议在治疗算法中更早地使用BEL。随着2021年批准用于LN, BEL越来越多地用于肾脏表现和一线治疗。安全性数据证实了其耐受性,而不会显著增加严重感染。然而,西班牙的实际证据表明,SLE和LN的这些建议存在差异。BEL治疗的最佳患者是患有轻度、中度或重度SLE,不能用羟氯喹(HCQ)控制,有或没有糖皮质激素(GC)和免疫抑制剂(is),病程≤2年,无初始器官损害,GC剂量≥5mg /天,严重发作风险高的患者。需要进一步的研究来确定BEL起始的最佳时机,以改善患者的预后和改变病程。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Belimumab patient profile in Spain: evolution during the last decade and future directions.

Introduction: Belimumab (BEL), an anti B-lymphocyte stimulator monoclonal antibody, is the only approved biological therapy for systemic lupus erythematosus (SLE) and lupus nephritis (LN).

Areas covered: This review discusses BEL's real-world use and its positioning in clinical practice guidelines, focusing on the evolution of its application and patient profile over the last decade in Spain.

Expert opinion: Initially used for refractory and non-major SLE manifestations, BEL's application has expanded. International guidelines now recommend earlier use of BEL in treatment algorithms. With its 2021 approval for LN, BEL is increasingly used for renal manifestations and as a first-line therapy. Safety data confirm its tolerability without a significant increase in severe infections. However, real-world evidence in Spain reveals discrepancies with these recommendations for both SLE and LN. The optimal patient for BEL treatment is one with mild, moderate, or severe SLE that cannot be controlled with hydroxychloroquine (HCQ), with or without glucocorticoids (GC) and immunosuppressants (IS), in patients with a disease duration of ≤2 years, no initial organ damage, GC doses ≥5 mg/day, and a high risk of severe flares. Further studies are needed to determine the optimal timing for BEL initiation to improve patient outcomes and modify the disease course.

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来源期刊
Expert Opinion on Biological Therapy
Expert Opinion on Biological Therapy 医学-生物工程与应用微生物
CiteScore
8.60
自引率
0.00%
发文量
96
审稿时长
3-8 weeks
期刊介绍: Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.
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