Teclistamab is a B‑cell maturation antigen (BCMA) × CD3 bispecific antibody used in relapsed/refractory multiple myeloma. While clinical trials established efficacy and described a range of adverse events, the postmarketing, real-world safety profile requires further characterization. The authors aimed to evaluate adverse event signals, temporal patterns, and clinical priorities associated with teclistamab using reports submitted to the FDA Adverse Event Reporting System (FAERS).
The investigators performed a retrospective analysis of FAERS reports spanning 2022 through 2025. They applied four complementary disproportionality methods to detect reporting signals: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). In addition to signal detection, the study assessed time‑to‑onset metrics and applied Weibull and Kaplan‑Meier approaches to temporal analyses. A semi‑quantitative clinical prioritization framework was used to rank detected signals according to clinical importance.
A total of 2,631 FAERS reports mentioning teclistamab were retrieved for the study period. Of these reports, 85.2% were recorded as involving serious outcomes. Fatal outcomes were reported in 21.7% of cases. The most frequently reported system organ class was infections and infestations, indicating an important burden of infectious complications among submitted reports.
Disproportionality analysis identified 70 significant preferred‑term signals associated with teclistamab. Of these, 52 corresponded to previously documented adverse events and 18 were characterized as novel signals within this dataset. Among the most frequently reported preferred terms were cytokine release syndrome (CRS), immune effector cell‑associated neurotoxicity syndrome (ICANS), infection, pneumonia, pyrexia, and neutropenia.
Using the study’s clinical prioritization process, sepsis was the sole signal classified as high priority. Notably, sepsis‑related reports had a high case fatality proportion, with 58.57% of sepsis reports indicating fatal outcomes. This concentrated morbidity and mortality linked to sepsis emerged as a prominent concern in the postmarketing data.
The time‑to‑onset analyses and related temporal methods showed distinct patterns by event type. Immune‑related events and neurological toxicities (for example, CRS and ICANS) tended to occur earlier after teclistamab exposure. By contrast, infectious complications generally manifested later in the course of exposure. These temporal distinctions have implications for monitoring intensity and duration after dosing.
Overall safety profiles were reported to be generally consistent across sex and age categories. However, the analysis identified a sex‑specific difference for one severe infectious outcome: septic shock was less frequently reported among female patients compared with male patients in the FAERS dataset. No other major sex‑ or age‑specific divergences were noted in the reported summary.
The authors observed that the postmarketing safety profile of teclistamab in FAERS broadly aligns with adverse events reported in clinical trials, particularly regarding immune‑mediated toxicities and hematologic events such as neutropenia. Nonetheless, the identification of 18 novel preferred‑term signals and the concentrated fatality associated with sepsis represent clinically important findings that extend beyond trial datasets. The temporal finding—that immune and neurologic events occur early while infections occur later—supports tailored surveillance strategies addressing both immediate and delayed risks.
Given the high proportion of serious outcomes and the notable sepsis fatality rate among reports, the study emphasizes the need for targeted risk mitigation measures and sustained pharmacovigilance focused on severe infections and immune‑related toxicities in patients receiving teclistamab.
The abstract reports findings from FAERS, a spontaneous reporting system subject to reporting bias, variable completeness, and inability to establish causality; these inherent limitations temper interpretation of signal strength and frequency. The summary in the source does not provide granular patient‑level or exposure‑adjusted incidence rates, and such details were not reported in the abstract.
In conclusion, this FAERS disproportionality analysis of teclistamab identified multiple expected adverse event signals and several novel signals, with sepsis singled out as a high‑priority concern given the high proportion of fatal outcomes among related reports. The authors recommend continued monitoring and focused clinical strategies to mitigate risks from severe infections and immune‑related toxicities in the postmarketing setting.