Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157-1071, USA.
Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Am J Clin Dermatol. 2021 Mar;22(2):221-231. doi: 10.1007/s40257-020-00569-1. Epub 2020 Nov 9.
Anti-drug antibodies (ADAs) may develop against originator biologic and biosimilar therapies used for the treatment of psoriasis and may be the cause of initial therapeutic non-response or diminished therapeutic response over time. Comparing immunogenicity between therapeutic agents is challenging owing to the variation in assays used for detection, among other reasons. Using the results of a PubMed search for psoriasis clinical trials disclosing the rates of ADAs for originator biologic and biosimilar therapies approved for the treatment of psoriasis within the last 5 years, this review discusses the rates and potential clinical impact of ADA formation in patients with psoriasis managed with originator biologic and biosimilar therapies, along with novel methods of ADA testing. Anti-drug antibodies are detectable in all biologic and biosimilar therapies approved for the treatment of psoriasis in the last 5 years, and the effect of ADAs on clinical response varies by agent. Novel immunoassays used for the detection of ADAs may have increased sensitivity compared with traditional assays, although the increased rate of detection may not correlate with decreased clinical response and the decision to test for the presence of ADAs may vary from patient to patient. Though ADA formation seems ubiquitous with the use of biologic agents for the treatment of psoriasis, the increased rates of ADAs detected by novel immunoassays may not necessarily correlate with decreased treatment efficacy.
抗药物抗体 (ADAs) 可能会针对用于治疗银屑病的原创生物制剂和生物类似药产生，并且可能是初始治疗无应答或随着时间的推移治疗应答减弱的原因。由于检测中使用的检测方法等原因，比较治疗药物的免疫原性具有挑战性。本文使用 PubMed 搜索银屑病临床试验的结果，这些试验披露了过去 5 年内批准用于治疗银屑病的原创生物制剂和生物类似药的 ADA 发生率，讨论了 ADA 在接受原创生物制剂和生物类似药治疗的银屑病患者中的形成率和潜在临床影响，以及 ADA 检测的新方法。在过去 5 年中，所有批准用于治疗银屑病的生物制剂和生物类似药均可检测到 ADA，ADA 对临床反应的影响因药物而异。用于检测 ADA 的新型免疫分析方法与传统分析方法相比可能具有更高的灵敏度，尽管检测到的 ADA 增加率可能与临床反应降低无关，并且检测 ADA 存在的决定可能因患者而异。尽管 ADA 形成似乎在使用生物制剂治疗银屑病时普遍存在，但新型免疫分析方法检测到的 ADA 增加率不一定与降低的治疗效果相关。
