Risks and safety of biologics: A practical guide for allergists

• Published in: The World Allergy Organization journal Vol. 16; no. 1; p. 100737
• Main Authors: Sitek, Andrea N., Li, James T., Pongdee, Thanai
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2023; Elsevier BV; World Allergy Organization; Elsevier
• Subjects: Adverse events; Allergies; Allergy; Anaphylaxis; Asthma; Biological products; Biologics; Birth defects; Birth weight; Case reports; Congenital diseases; Drug dosages; FDA approval; Fetuses; Gestational age; Immunization; Immunology; Infections; Miscarriage; Monoclonal antibodies; Observational studies; Patients; Pregnancy; Review; Risks; Safety; Task forces; Womens health; United States > US; Risks; Allergy; Safety; Adverse events; Biologics
• ISSN: 1939-4551; 1939-4551
• DOI: 10.1016/j.waojou.2022.100737

Biologic agents are a rapidly expanding class of medications, and several options are now available for the management of allergic and immunologic disorders. The risks of biologic therapy need to be understood in order to adequately counsel patients and appropriately monitor for potential adverse events. We sought to provide a comprehensive review of the risks and adverse effects reported for the current FDA-approved biologics used in management of allergic and immunologic disorders, including omalizumab, benralizumab, dupilumab, mepolizumab, reslizumab, tezepelumab and tralokinumab. Our review focuses on the risk of hypersensitivity reactions, pregnancy-specific considerations, risk of infection and risk of malignancy. We also highlight drug-specific adverse events and unique safety issues identified in case reports.