What question did this study set out to answer?

To evaluate adverse event signals, onset timelines, and clinical priorities associated with teclistamab using post-marketing surveillance data.

September 17, 2026HematologyOpen Access

Teclistamab-associated adverse events: a disproportionality analysis of the FDA adverse event reporting system

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Pharmacovigilance study reveals high rates of serious infections and neurotoxicity with teclistamab, highlighting severe sepsis risks.

To evaluate adverse event signals, onset timelines, and clinical priorities associated with teclistamab using post-marketing surveillance data.
Retrospective disproportionality analysis of FDA Adverse Event Reporting System (FAERS) reports from 2022 to 2025.
Calculated reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker metrics alongside time-to-onset analyses.
Analyzed 2,631 teclistamab reports, finding serious outcomes in 85.2% and fatal outcomes in 21.7% of cases.
Identified 70 significant preferred-term signals (52 known, 18 novel), most frequently involving cytokine release syndrome, neurotoxicity syndrome, infection, pneumonia, pyrexia, and neutropenia.
Sepsis emerged as the single high-priority signal with a 58.57% fatality rate among sepsis-related reports, showing delayed onset relative to early immune-mediated toxicities.

He et al. (2026) studied this question.

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September 17, 2026HematologyOpen Access

View Full Paper

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Authors

Pharmacovigilance study reveals high rates of serious infections and neurotoxicity with teclistamab, highlighting severe sepsis risks.

To evaluate adverse event signals, onset timelines, and clinical priorities associated with teclistamab using post-marketing surveillance data.
Retrospective disproportionality analysis of FDA Adverse Event Reporting System (FAERS) reports from 2022 to 2025.
Calculated reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker metrics alongside time-to-onset analyses.
Analyzed 2,631 teclistamab reports, finding serious outcomes in 85.2% and fatal outcomes in 21.7% of cases.
Identified 70 significant preferred-term signals (52 known, 18 novel), most frequently involving cytokine release syndrome, neurotoxicity syndrome, infection, pneumonia, pyrexia, and neutropenia.
Sepsis emerged as the single high-priority signal with a 58.57% fatality rate among sepsis-related reports, showing delayed onset relative to early immune-mediated toxicities.

He et al. (2026) studied this question.

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