{
  "abstract": "Background: Teclistamab plus daratumumab (Tec-Dara) was approved in March 2026 for relapsed or refractory multiple myeloma, but infections are frequent. We hypothesized that dual BCMA- and CD38-directed immune depletion causes infectious toxicity exceeding that expected from either agent alone. Methods: In the FDA Adverse Event Reporting System (FAERS; Q4 2022–Q4 2025; all combination reports pre-approval), we compared reports listing both agents (n = 353) with teclistamab-only (n = 2774) and daratumumab-only (n = 19,230) reports. Interaction was quantified as Ω = RORcombination/(RORteclistamab × RORdaratumumab), where ROR is the reporting odds ratio, with sensitivity analyses addressing calendar period, sparse counts, comparator, and confounding. Results: Pneumonia (Ω, 1.50; 95% CI, 1.06–2.12) and influenza (Ω, 2.63; 95% CI, 1.20–5.77) were reported more often than expected. The pneumonia estimate increased against a myeloma-restricted background and after covariate adjustment, but was no longer statistically significant after excluding reports co-listing immunomodulatory drugs or proteasome inhibitors or with a relapsed-disease daratumumab comparator. Cytokine release syndrome, neurotoxicity, and cytopenias were reported less often than expected, a reporting pattern rather than protection. A bone marrow failure signal rested on few reports and is hypothesis-generating only. Conclusions: Consistent with our hypothesis, Tec-Dara was associated with higher-than-expected reporting of respiratory infections, although confounding by treatment population cannot be excluded. Any new respiratory symptom or fever warrants same-day evaluation.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Internal Medicine, St. John’s Episcopal Hospital, New York, NY 11691, USA",
    "Department of Internal Medicine, Landmark Medical Center, Woonsocket, RI 02895, USA",
    "Division of Hematologic Malignancies and Cellular Therapeutics, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS 66160, USA",
    "Stem Cell Transplantation and Cellular Immunotherapy Program, Department of Hematology/Oncology, UMC TLC2 Foundation Cancer Center, Texas Tech University Health Sciences Center, Lubbock, TX 79430, USA"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 4,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Carmel Awadallah"
    },
    {
      "affs": [
        1
      ],
      "name": "Sohaib Irfan"
    },
    {
      "affs": [
        2
      ],
      "name": "Al-Ola Abdallah",
      "orcid": "0000-0002-6603-185X"
    },
    {
      "affs": [
        3
      ],
      "name": "Muhammad Bilal Abid",
      "orcid": "0000-0002-1128-0445"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/a8ympb95pk9fk.bib",
  "cited_by": 0,
  "doi": "10.3390/cancers18203388",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13702562/?tool=EBI",
  "id": "a8ympb95pk9fk",
  "issns": [
    "2072-6694"
  ],
  "landing_url": "https://www.mdpi.com/2072-6694/18/20/3388",
  "language": "eng",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2720|Multiple Myeloma Research and Treatments"
    ]
  ],
  "openalex": "W7223030524",
  "pdf_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13702562/pdf/?tool=EBI",
  "pmcid": "PMC13702562",
  "pmid": null,
  "published": "2026-10-01",
  "publisher": "MDPI AG",
  "ris": "https://research.draconitic.com/paper/a8ympb95pk9fk.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:58Z",
      "native_id": "10.3390/cancers18203388",
      "source": "crossref",
      "url": "https://www.mdpi.com/2072-6694/18/20/3388"
    },
    {
      "first_seen": "2026-10-30T12:21:47Z",
      "native_id": "PMC:PMC13702562",
      "source": "europepmc",
      "url": "https://europepmc.org/article/PMC/PMC13702562"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "issn:2072-6694",
      "subfield": "oncology"
    }
  ],
  "title": "Infectious Complications and Toxicities of the Teclistamab Plus Daratumumab Combination in Relapsed or Refractory Multiple Myeloma: A Disproportionality and Drug–Interaction Analysis of the FDA Adverse Event Reporting System",
  "title_text": "Infectious Complications and Toxicities of the Teclistamab Plus Daratumumab Combination in Relapsed or Refractory Multiple Myeloma: A Disproportionality and Drug–Interaction Analysis of the FDA Adverse Event Reporting System",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:21:47Z",
  "url": "https://research.draconitic.com/paper/a8ympb95pk9fk",
  "venue": "Cancers",
  "versions": []
}