Data Sheet 1_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.pdf

CRS had higher primary adjusted reporting odds for epcoritamab (aROR 4.70, 95% CI 4.15 to 5.32), glofitamab (3.43, 2.94 to 4.00), and mosunetuzumab (6.23, 4.97 to 7.81). ICANS had higher reporting odds for epcoritamab (2.28, 1.87 to 2.80); the glofitamab estimate crossed 1 in the primary model (1.26, 0.93 to 1.70) and varied with covariate specification, while mosunetuzumab ICANS was sparse. Epcoritamab had higher reporting odds for CMV (4.54, 3.66 to 5.62) and narrow opportunistic infection (2.20, 1.84 to 2.63).

Mosunetuzumab had higher reporting odds for pneumonia/lower respiratory infection (1.74, 1.32 to 2.31) and COVID-19 (1.66, 1.25 to 2.21), although these infection-specific patterns attenuated in some geographic and calendar restrictions. Immune-effector and infectious phenotypes co-occurred in reports containing serious outcomes. TTO was calculable for 33.7%–61.2% of reports and suggested earlier CRS than infection-associated reporting, but report characteristics differed by TTO completeness.</p>Conclusions<p>CRS was the clearest shared reporting pattern across the three CD20×CD3 antibodies.

Neurotoxicity and infection-associated findings were more drug- and analysis-dependent. Report-level co-reporting supports concurrent consideration of inflammatory toxicity and infection when presentations overlap, while later infection-associated TTO distributions support continued awareness beyond step-up dosing. Spontaneous-reporting data cannot estimate incidence, causality, or comparative treatment risk.</p>