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

Teclistamab-associated adverse event reports showed a high burden of serious and fatal outcomes in real-world post-marketing data.

• A total of 2,631 FAERS reports were analyzed from 2022 to 2025.
• 85.2% of reports involved serious outcomes.
• 21.7% of reports involved fatal outcomes.
• Four disproportionality methods were used: reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker.

The most frequently reported system organ class in teclistamab adverse event reports was infections and infestations.

• Infections and infestations represented the top system organ class among reported adverse events.
• Cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, infection, pneumonia, pyrexia, and neutropenia were among the most frequently reported preferred-term signals.
• This finding highlights the predominance of infectious complications in the real-world safety profile of teclistamab.

Seventy significant preferred-term adverse event signals were identified, including 18 novel signals not previously documented in clinical trials.

• Of the 70 significant signals, 52 were previously documented and 18 were novel.
• The identification of novel signals suggests that post-marketing surveillance captures additional safety information beyond clinical trial data.
• The safety profile broadly aligned with clinical trial data but the novel signals highlighted clinically important risks.

Sepsis was identified as the sole high-priority adverse event signal, with a majority of sepsis-related reports resulting in fatal outcomes.

• Sepsis was the only signal classified as high-priority using semi-quantitative clinical prioritization analysis.
• Fatal outcomes occurred in 58.57% of sepsis-related reports.
• This finding underscores sepsis as a particularly dangerous complication associated with teclistamab use.

Immune-related and neurological adverse events occurred earlier in the course of teclistamab treatment, whereas infectious complications tended to occur later.

• Time-to-onset analysis using Weibull and Kaplan-Meier methods characterized temporal patterns of adverse events.
• Immune effector cell-associated neurotoxicity syndrome and cytokine release syndrome were among the earlier-occurring events.
• Infectious complications, including pneumonia and sepsis, demonstrated a tendency toward later onset.
• This temporal differentiation has implications for clinical monitoring schedules.

Safety profiles were generally consistent across sex and age groups, with the exception that septic shock was less frequently reported in females.

• Subgroup analyses by sex and age showed broadly consistent adverse event patterns.
• Septic shock was identified as an exception, being less frequently reported in female patients.
• No other major sex- or age-related differences in safety signals were highlighted.

The study identified that targeted risk mitigation and continued monitoring are supported particularly for severe infections and immune-related toxicities.

• The findings support the need for targeted risk mitigation strategies based on the temporal patterns and severity of identified signals.
• Novel signals and sepsis-related fatality were highlighted as clinically important risks beyond those characterized in clinical trials.
• The authors conclude that continued pharmacovigilance is warranted for teclistamab in the post-marketing setting.