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Updated: Mar 13, 2026
Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
Published on: September 15, 2023
An overview on safety of monoclonal antibodies
Andrea Matucci1, Francesca Nencini, Sara Pratesi
1aImmunoallergology Unit, AOU Careggi bDepartment of Experimental and Clinical Medicine, Centre of Excellence DENOTHE, University of Florence, Florence, Italy.
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.
