最近上市的单克隆抗体治疗后的DRESS综合征病例报告和与DRESS综合征一致的症状

IF 1.7 Q4 IMMUNOLOGY
James C Di Palma-Grisi, K. Vijayagopal, Muhammad A Muslimani
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引用次数: 15

摘要

单克隆抗体是一种有效且广泛耐受的药物类别,代表了近年来第一个新批准的治疗方法。因此,许多药物被美国食品和药物管理局授予“快速通道”或“突破性疗法”的称号,从而在III期临床试验报告之前获得临时批准。虽然这些药物通常是安全的,但有些患者会出现危及生命的并发症——肌炎和脑炎会导致永久性或暂时性的召回。药物反应伴嗜酸性粒细胞增多及全身症状(DRESS)综合征是一种易被忽视的超敏性疾病,其潜伏期长且表现非特异性。这篇迷你评论主要是为了给那些可能正在使用这些强有力的治疗方法的从业者提供一个简短的指南。我们使用一系列与DRESS综合征一致的症状和FDA自2015年以来批准的单克隆抗体在PubMed中进行检索。然后,我们排除了报告非疱疹性感染再激活、免疫缺陷相关感染或注射部位或输注反应的皮肤病并发症的研究。我们通过PubMed、Mendeley和Google Scholar搜索并访问了之前的评论和背景研究。结果文献中发现2例DRESS综合征,均为daclizumab治疗的结果。另外还有一例无皮肤症状的脑炎病例由daclizumab引起。在纳武单抗治疗后报告了药物性过敏性皮炎,两例伊匹单抗联合纳武单抗或杜伐单抗治疗,第一例患者出现斑疹丘疹和大疱,第二例患者出现地衣样皮炎和水疱。Daclizumab是最近批准的唯一与DRESS综合征相关的单克隆抗体。DRESS综合征作为一种临床实体的诊断可靠性存在局限性,而且缺乏负面的临床试验报告,这表明临床医生和监管机构有必要提高警惕。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Case Reports of DRESS Syndrome and Symptoms Consistent with DRESS Syndrome Following Treatment with Recently Marketed Monoclonal Antibodies
Background Monoclonal antibodies constitute a potent and broadly tolerable drug class, representing for some conditions the first newly approved treatment in years. As such, many are afforded “fast-track” or “breakthrough therapy” designations by the U.S. Food and Drug Administration, leading to provisional approval before Phase III clinical trials are reported. Although these drugs are usually safe, some patients experience life-threatening complications—myositis and encephalitis have led to permanent or temporary recalls. Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a hypersensitivity condition easily missed due to its long incubation period and nonspecific presentation. This minireview is primarily intended as an abbreviated guide for practitioners who may be using these powerful treatments. Methodology We searched PubMed using a string of symptoms consistent with DRESS syndrome and monoclonal antibodies approved by the FDA since 2015. Then, we excluded studies reporting dermatological complications of reactivation of nonherpetic infection, immunodeficiency-related infection, or reactions to the injection site or infusion. We searched for and accessed prior reviews and background studies via PubMed, Mendeley, and Google Scholar. Results Two cases of DRESS syndrome were identified in the literature, both the result of treatment with daclizumab. There was one additional case of encephalitis without cutaneous symptoms caused by daclizumab. Drug-induced hypersensitivity dermatitis was reported following treatment with nivolumab and two cases of combination treatment with ipilimumab and either nivolumab or durvalumab produced maculopapular rash and bullae in the first patient and lichenoid dermatitis and blisters in the second patient. Conclusions Daclizumab was the only recently approved monoclonal antibody associated with DRESS syndrome as such. Limitations in the diagnostic reliability of DRESS syndrome as a clinical entity and the lack of negative clinical trial reporting suggest enhanced vigilance on the part of clinicians and regulators may be warranted.
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来源期刊
Autoimmune Diseases
Autoimmune Diseases IMMUNOLOGY-
CiteScore
6.10
自引率
0.00%
发文量
9
审稿时长
17 weeks
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