An update on the safety of biologic therapies for the treatment of polyarticular juvenile idiopathic arthritis.

IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-02-16 DOI:10.1080/14740338.2025.2467179
Angela Zimmer, Gerd Horneff
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引用次数: 0

Abstract

Introduction: An increasing number of patients with polyarticular course juvenile idiopathic arthritis are treated with biologics with great efficacy. Consequently, the importance regarding safety data in general as well as especially serious infections, incident autoimmune processes, or malignancies rises. In children, this is crucial concerning occurrences that manifest rarely and only after a prolonged latency period.

Areas covered: This study aims to analyze safety under therapy with the five most commonly used biologicals for the treatment of juvenile idiopathic arthritis in Germany: abatacept, adalimumab, etanercept, golimumab, and tocilizumab, and a control cohort, who received methotrexate. For this, data from the Biologics in Pediatric Rheumatology (BiKeR) Registry were analyzed with a focus on potential adverse drug reactions like serious infections, autoimmune processes or malignancies.

Expert opinion: Besides JIA category-specific differences, investigating side effects like severe infections and the development of additional autoimmune processes due to therapy is crucial. Future clinical randomized double-blinded studies are essential for direct drug comparisons, enabling optimal individualized therapy considering comorbidities and individual risks. Large patient data over a (life-)long period beyond childhood are particularly important, especially concerning the risk of malignancy after prolonged latency.

生物疗法治疗多关节幼年特发性关节炎安全性的最新进展。
越来越多的多关节病程青少年特发性关节炎患者采用生物制剂治疗,疗效显著。因此,安全性数据的重要性一般以及特别严重的感染、偶发的自身免疫过程或恶性肿瘤上升。在儿童中,这是至关重要的,因为这种情况很少出现,而且只有在长潜伏期后才会出现。涵盖领域:本研究旨在分析德国治疗青少年特发性关节炎的五种最常用生物制剂的安全性:阿巴接受、阿达木单抗、依那西普、戈利木单抗和托珠单抗,以及接受甲氨蝶呤治疗的对照队列。为此,我们分析了来自儿科风湿病学生物制剂(Biologics in Pediatric Rheumatology, BiKeR) Registry的数据,重点分析了药物的潜在不良反应,如严重感染、自身免疫过程或恶性肿瘤。专家意见:除了JIA类别特异性差异外,调查严重感染等副作用以及治疗导致的额外自身免疫过程的发展至关重要。未来的临床随机双盲研究对直接药物比较至关重要,可以考虑合并症和个体风险,实现最佳的个体化治疗。儿童期以后(终生)的大量患者数据尤其重要,特别是涉及到延长潜伏期后发生恶性肿瘤的风险。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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