Ludwig-Maximilian University, Department of Dermatology and Allergology, Munich, Germany.
Expert Opin Drug Saf. 2012 Nov;11(6):911-21. doi: 10.1517/14740338.2012.727796. Epub 2012 Sep 24.
Etanercept (ETN) is a tumor necrosis factor alpha (TNF-α) antagonist used for the treatment of chronic inflammatory disorders. Injection site reactions (ISRs) are reported to be the most common adverse event of ETN therapy. While their mechanisms are not completely understood, the occurrence of ETN-ISRs could indicate a risk of systemic immune-mediated severe adverse drug reactions.
Based on two cases and a review of the literature, the characteristics and frequency of ETN-ISRs were assessed. This article discusses their potential mechanisms and clinical relevance, and provides recommendations for the management of patients presenting with ETN-ISRs.
Basically, irritative and immune-mediated ISRs may be distinguished. The formation of anti-drug antibodies (ADAs) may promote immune-mediated ISRs that likely represent either anaphylactic type I reactions, or cutaneous Arthus-like type III reactions according to the Coombs and Gell classification. A differentiation between these reactions by clinical course and etanercept-skin testing may help to decide if ETN treatment should be stopped to avoid the development of more severe adverse drug reactions if ISRs occur.
依那西普(ETN)是一种肿瘤坏死因子-α(TNF-α)拮抗剂,用于治疗慢性炎症性疾病。据报道,注射部位反应(ISRs)是 ETN 治疗最常见的不良事件。虽然其机制尚不完全清楚,但 ETN-ISRs 的发生可能表明存在全身性免疫介导的严重药物不良反应的风险。
基于两例病例和文献复习,评估了 ETN-ISRs 的特征和频率。本文讨论了它们的潜在机制和临床相关性,并为出现 ETN-ISRs 的患者的管理提供了建议。
基本上,可以区分刺激性和免疫介导的 ISRs。形成抗药物抗体(ADAs)可能会促进免疫介导的 ISRs,根据 Coombs 和 Gell 分类,这些反应可能代表过敏反应 I 型或皮肤 Arthus 样反应 III 型。通过临床过程和依那西普皮肤试验对这些反应进行区分,有助于决定是否停止 ETN 治疗,以避免如果发生 ISRs 而出现更严重的药物不良反应。