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An overview on safety of monoclonal antibodies

Matucci, Andrea; Nencini, Francesca; Pratesi, Sara; Maggi, Enrico; Vultaggio, Alessandra

Current Opinion in Allergy and Clinical Immunology: December 2016 - Volume 16 - Issue 6 - p 576–581
doi: 10.1097/ACI.0000000000000315
IMMUNOTHERAPY AND NEW TREATMENTS: Edited by Giovanni Passalacqua and Robert Bush

Purpose of review 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.

Recent findings 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.

Summary The safety profile of biological agents is, just as much as their efficacy, one of the fundamental criteria justifying their clinical broad use.

aImmunoallergology Unit, AOU Careggi

bDepartment of Experimental and Clinical Medicine, Centre of Excellence DENOTHE, University of Florence, Florence, Italy

Correspondence to Andrea Matucci, MD, Immunoallergology Unit, AOU Careggi, Largo Brambilla 3, 50134 Florence, Italy. Tel: +390552751816; fax: +390557947425; e-mail:

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