Hypersensitivity reactions to biologics in chronic rheumatic diseases: prevalence and associated factors.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2025-09-26 DOI:10.1080/14740338.2025.2567588

Selma Bouden, Amel Hajjem, Leila Rouached, Aicha Ben Tekaya, Siwar Ben Dhia, Ines Mahmoud, Rawdha Tekaya, Olfa Saidane, Leila Abdelmoula

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引用次数: 0

Abstract

Background: The aim of our study was to determine the prevalence of hypersensitivity reactions in patients with chronic rheumatic diseases (CRD) treated with biologic therapies, and to evaluate the associated factors.

Research design and methods: A 6-year retrospective, single-center study was performed, including patients with CRD treated with biologic therapies.

Results: A total of 151 patients (109 women and 42 men) with a mean age of 53.2 ± 13.6 years were included. They were followed for rheumatoid arthritis (59.6%), spondyloarthritis (31.8%), juvenile idiopathic arthritis (6%), rhupus syndrome and scleroderma (1.3% each). Anti-TNF alpha agents were the most frequently prescribed biologic class (67.5%). However, anti-CD20 (Rituximab) was the most frequently prescribed molecule (23.2%). Hypersensitivity reactions occurred in 16.6% (n = 25), mainly systemic (72%) and immediate (84%). The positivity of the rheumatoid factor (p = 0.01), and the axial phenotype of spondyloarthritis (p = 0.01) were significantly associated with the occurrence of hypersensitivity reactions. Infliximab was the biologic agent most associated with hypersensitivity reactions (p = 0.002). Etanercept was most frequently associated with local hypersensitivity reactions (p = 0.04). Concomitant Methotrexate use significantly decreased the risk of hypersensitivity reactions (p = 0.01).

Conclusions: Considering the predictive factors of hypersensitivity reactions to biologics in clinical practice could help anticipate risks and improve patient safety.

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慢性风湿病患者对生物制剂的超敏反应：患病率及相关因素

背景：本研究的目的是确定慢性风湿病（CRD）患者接受生物治疗时超敏反应的发生率，并评价相关因素。研究设计和方法：我们进行了一项为期6年的回顾性单中心研究，包括接受生物治疗的CRD患者。结果：共纳入151例患者，其中女性109例，男性42例，平均年龄53.2±13.6岁。类风湿关节炎（59.6%）、脊椎关节炎（31.8%）、青少年特发性关节炎（6%）、鲁普斯综合征（rhupus syndrome）和硬皮病（sclerosis derma）各占1.3%。抗tnf α药物是最常用的生物类药物（67.5%）。然而，抗cd20（利妥昔单抗）是最常用的处方分子（23.2%）。过敏反应发生率为16.6% (n = 25)，主要为全身性（72%）和立即性（84%）。类风湿因子阳性（p = 0.01）和脊柱炎轴型（p = 0.01）与超敏反应的发生有显著相关性。英夫利昔单抗是与过敏反应最相关的生物制剂（p = 0.002）。依那西普最常与局部超敏反应相关（p = 0.04）。同时使用甲氨蝶呤可显著降低过敏反应的发生风险（p = 0.01）。结论：在临床实践中考虑生物制剂超敏反应的预测因素有助于预测风险，提高患者的安全性。

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

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

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.