MRC Centre for Drug Safety Science and Institute of Translational Medicine, Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool L69 3GE, UK.
Nat Rev Drug Discov. 2013 Apr;12(4):306-24. doi: 10.1038/nrd3974.
Immunomodulatory biologics, which render their therapeutic effects by modulating or harnessing immune responses, have proven their therapeutic utility in several complex conditions including cancer and autoimmune diseases. However, unwanted adverse reactions--including serious infections, malignancy, cytokine release syndrome, anaphylaxis and hypersensitivity as well as immunogenicity--pose a challenge to the development of new (and safer) immunomodulatory biologics. In this article, we assess the safety issues associated with immunomodulatory biologics and discuss the current approaches for predicting and mitigating adverse reactions associated with their use. We also outline how these approaches can inform the development of safer immunomodulatory biologics.
免疫调节剂通过调节或利用免疫反应来发挥治疗作用，已在多种复杂疾病（包括癌症和自身免疫性疾病）中证明了其治疗效果。然而，意想不到的不良反应——包括严重感染、恶性肿瘤、细胞因子释放综合征、过敏反应和过敏以及免疫原性——给新型（更安全）免疫调节剂的开发带来了挑战。本文评估了与免疫调节剂相关的安全问题，并讨论了目前用于预测和减轻与使用相关的不良反应的方法。我们还概述了这些方法如何为更安全的免疫调节剂的开发提供信息。
