Frontiers in immunology
Immune-effector and infection-associated reporting patterns of CD20×CD3 bispecific antibodies in B-cell lymphoma: a label-anchored FAERS analysis with descriptive JADER contextualization
By Zhong H, Liu Y, Lin Y and 2 others.
Abstract
Background
CD20×CD3 bispecific antibodies are associated with acute immune-effector toxicities and infections, but drug-specific postmarketing co-reporting and report-level onset patterns remain incompletely characterized in B-cell lymphoma.
Methods
We performed a label-anchored FAERS pharmacovigilance analysis with descriptive JADER contextualization. Deduplicated FAERS reports from 2022 Q4 through 2026 Q1 were restricted to primary-suspect epcoritamab, glofitamab, or mosunetuzumab reports in B-cell lymphoma, yielding 2,879 exposed reports. Prespecified MedDRA endpoints were evaluated against a disease-restricted comparator. Primary adjusted reporting odds ratios (aRORs) accounted for demographics, disease subgroup, reporting region, and calendar year. We mapped report-level phenotype intersections, summarized time to onset (TTO), and performed model-specification, restriction, comparator-exclusion, and TTO-completeness analyses.