{
  "abstract": "Background T-cell-engaging bispecific agents and related T-cell-engaging therapies are increasingly used across hematologic malignancies and selected solid tumors. Infection is a clinically important safety concern, but infection-focused post-marketing comparisons across the current product set remain limited. We evaluated infection-related adverse event reporting for T-cell-engaging agents using the FDA Adverse Event Reporting System/Adverse Event Monitoring System (FAERS/AEMS). Methods Public FAERS/AEMS quarterly ASCII files from 2022Q1 to 2026Q1 were analyzed. Reports were deduplicated by retaining the latest case version for each CASEID, and exposure was defined as a target T-cell-engaging agent recorded as the primary suspect drug. Infection-related events were identified with a prespecified MedDRA preferred-term dictionary and were summarized using a structured dominant-category framework. Disproportionality was assessed using reporting odds ratio (ROR) with 95% confidence interval (CI), with proportional reporting ratio (PRR) and information component (IC) as supportive metrics. Reporting followed the READUS-PV guideline for disproportionality analyses of individual case safety reports. Results Among 6,102,203 deduplicated primary-suspect reports, 15,108 involved a target T-cell-engaging agent, of which 3,114 were infection-related (20.6%). The class-level infection-related reporting signal was significant (ROR 2.03 (1.95-2.11); IC025 0.80). The largest number of infection-related reports was observed for Teclistamab (Tecvayli) (829 reports), whereas the highest drug-level ROR was observed for Elranatamab (Elrexfio) (ROR 4.38 (3.94-4.87)). Prominent preferred-term signals included pneumonia (ROR 2.01 (1.84-2.21)), sepsis (ROR 3.76 (3.32-4.24)), septic shock (ROR 4.39 (3.71-5.19)), cytomegalovirus infection reactivation (ROR 27.19 (23.39-31.60)), and cytomegalovirus infection (ROR 12.60 (10.71-14.82)). The class-level signal persisted under the narrower infection definition (2,545 reports; ROR 1.95, 95% CI 1.87-2.03). Concordant DailyMed infection terms and FAERS/AEMS infection signals were found for 7 agents. Conclusions FAERS/AEMS data showed a class-level reporting signal for infection-related adverse events with T-cell-engaging agents, particularly among BCMA x CD3 and CD20 x CD3 therapies. Cytomegalovirus-related events, pneumonia, and sepsis were prominent signal patterns. These findings are hypothesis-generating reporting patterns and should not be interpreted as incidence estimates, relative risks, or proof of causality.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": null,
  "arxiv": null,
  "author_total": 4,
  "authors": [
    {
      "name": "Shui Liu"
    },
    {
      "name": "Ye Tan"
    },
    {
      "name": "Aidong Chen"
    },
    {
      "name": "Qian Liu"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/c8k9k4s3625xw.bib",
  "cited_by": 0,
  "doi": "10.1177/03946320261499210",
  "fulltext_url": "https://doi.org/10.1177/03946320261499210",
  "id": "c8k9k4s3625xw",
  "issns": [
    "2058-7384",
    "0394-6320"
  ],
  "landing_url": "https://doi.org/10.1177/03946320261499210",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "lcc",
      "RB1-214"
    ],
    [
      "lcc",
      "RC581-607"
    ],
    [
      "lcc",
      "RM1-950"
    ],
    [
      "openalex",
      "3005|Pharmacovigilance and Adverse Drug Reactions"
    ]
  ],
  "openalex": "W7224118651",
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-28",
  "publisher": "SAGE Publishing",
  "ris": "https://research.draconitic.com/paper/c8k9k4s3625xw.ris",
  "sources": [
    {
      "first_seen": "2026-10-31T14:22:11Z",
      "native_id": "33f2b4f70bcf4f9abc6cbbaa1683c8d1",
      "source": "doaj",
      "url": "https://doi.org/10.1177/03946320261499210"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:3005|Pharmacovigilance and Adverse Drug Reactions",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Infection-related adverse events associated with T-cell-engaging bispecific agents: A real-world pharmacovigilance study using FAERS/AEMS",
  "title_text": "Infection-related adverse events associated with T-cell-engaging bispecific agents: A real-world pharmacovigilance study using FAERS/AEMS",
  "type": "peer-reviewed",
  "updated_at": "2026-10-31T14:22:11Z",
  "url": "https://research.draconitic.com/paper/c8k9k4s3625xw",
  "venue": "International Journal of Immunopathology and Pharmacology",
  "versions": []
}