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Updated: Mar 8, 2026

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
Published on: September 15, 2023
Current Knowledge and Management of Hypersensitivity Reactions to Monoclonal Antibodies
Matthieu Picard1, Violeta Régnier Galvão2
1Division of Allergy and Immunology, Department of Medicine, Hôpital Maisonneuve-Rosemont, Université de Montréal, Montréal, Québec, Canada.
Abstract:
Hypersensitivity reactions (HSRs) to monoclonal antibodies (mAbs) are increasingly frequent as this class of therapeutic agents is rapidly expanding. Immediate and nonimmediate HSRs have been reported with mAbs. Immediate HSRs can be explained by 3 main mechanisms: cytokine release syndrome, IgE-mediated, and IgG-mediated reactions. Importantly, IgE-mediated reactions can occur on first exposure due to preformed specific IgEs, as shown for cetuximab. Almost all patients with an immediate HSR can be safely re-exposed either through desensitization or challenge depending on the severity and mechanism of the initial reaction. An algorithm detailing the general approach to these HSRs and the preferred method of re-exposure is presented in this review. Also, the mAbs that are most frequently implicated in HSRs are discussed individually.
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