Matucci Andrea, Nencini Francesca, Pratesi Sara, Maggi Enrico, Vultaggio Alessandra
aImmunoallergology Unit, AOU Careggi bDepartment of Experimental and Clinical Medicine, Centre of Excellence DENOTHE, University of Florence, Florence, Italy.
Curr Opin Allergy Clin Immunol. 2016 Dec;16(6):576-581. doi: 10.1097/ACI.0000000000000315.
Biological agents have been a treatment option for many chronic immune-mediated diseases as well as oncological conditions. The issue of infusion reactions is of particular importance and at least in some cases related to the immunogenicity of these drugs with the production of antidrug antibodies. Infectious diseases are a well described side-effect of certain biological agents, even if, at least regarding the biological agents used for the treatment of allergic diseases and immune-mediated diseases, the risk has been reduced. Biological agents clearly impact the physiological functions of the immune system also those connected to immunosurveillance against cancers. This review discusses the safety profile to the main biological agents currently in use in allergic and chronic immune-mediated diseases.
By reducing chronic inflammation in immune-mediated diseases, biological agents decrease mortality, cardiovascular events without increasing significantly the risk of cancer. In addition, specific clinical procedure enables the identification of potentially reactive patients and the prevention of acute severe reactions. Overall, the ratio between therapeutic and side-effects is clearly in favor of the former.
The safety profile of biological agents is, just as much as their efficacy, one of the fundamental criteria justifying their clinical broad use.
生物制剂已成为许多慢性免疫介导疾病以及肿瘤疾病的一种治疗选择。输注反应问题尤为重要，至少在某些情况下与这些药物的免疫原性及抗药抗体的产生有关。传染病是某些生物制剂已明确描述的副作用，即便至少就用于治疗过敏性疾病和免疫介导疾病的生物制剂而言，其风险已有所降低。生物制剂显然会影响免疫系统的生理功能，包括与针对癌症的免疫监视相关的功能。本综述讨论了目前用于过敏性和慢性免疫介导疾病的主要生物制剂的安全性概况。
通过减轻免疫介导疾病中的慢性炎症，生物制剂可降低死亡率、心血管事件发生率，且不会显著增加癌症风险。此外，特定的临床程序能够识别潜在的反应性患者并预防急性严重反应。总体而言，治疗效果与副作用之比明显有利于前者。
生物制剂的安全性概况与其疗效一样，是证明其在临床上广泛应用的基本标准之一。
