Hypersensitivity Reactions to Biologics: Advances in Diagnosis and Management

The landscape of biologic therapeutics has expanded to include therapies such as antibody-drug conjugates (ADCs) and bispecific T-cell engagers. As the use of these therapies expands, hypersensitivity reactions (HSRs) can limit the use of preferred treatments. This review examines advances in the diagnosis and management of these adverse events, including applications of precision medicine and AllergoOncology.

Recent studies have identified hereditary alpha tryptasemia (HαT) and female sex as potential risk factors for biologic-induced anaphylaxis. Excipients such as PEG and polysorbates are increasingly recognized as potential triggers of first-exposure reactions. The basophil activation test (BAT) has emerged as a complementary tool for evaluating IgE-mediated hypersensitivity and differentiating it from cytokine release syndrome (CRS). Recent approaches to rapid drug desensitization (RDD) include one-bag protocols, same-day desensitization, and omalizumab as an adjunct in selected patients. The approach to biologic hypersensitivity is increasingly guided by reaction phenotype, diagnostic evaluation, and individualized management.