{
  "abstract": "BackgroundIn 2026, the US Food and Drug Administration (FDA) identified uveitis as a potential signal of serious risk for the B-cell maturation antigen (BCMA) x CD3 bispecific antibodies teclistamab and elranatamab. Uveitis in this setting may reflect opportunistic infection or immune-mediated inflammation, which require opposite management.\n\nMethodsWe analyzed FDA Adverse Event Reporting System (FAERS) reports from July 2020 to June 2026 (8,690,601 reports after deduplication) using a case-non-case design, calculating reporting odds ratios (RORs) and the information component for primary-suspect reports. Comparators were belantamab mafodotin, talquetamab and CD3 bispecific antibodies used outside myeloma. Every primary-suspect uveitis report (n = 76) was classified as infectious, probable immune-mediated (hereafter immune-mediated) or indeterminate by a physician blinded to a rule-based algorithm.\n\nResultsUveitis was reported in 18 of 2,995 teclistamab and 29 of 1,691 elranatamab reports (ROR 4.10 [95% CI 2.58-6.52] and 11.85 [8.21-17.12]). Of these 47 cases, 20 were infectious (18 cytomegalovirus chorioretinitis; median onset 92 days), and infection-specified uveitis was disproportionately reported for both agents and for CD3 bispecific antibodies used outside myeloma. Thirteen were immune-mediated, arose early (median onset 4 days) and were co-reported with cytokine release syndrome in six; immune-mediated uveitis showed a signal only for elranatamab (8 cases; ROR 3.59, 1.79-7.18), not for teclistamab or any comparator. Six of the eight elranatamab cases originated from Japan. Agreement between physician and algorithm was 98.7%.\n\nConclusionsThe FDA uveitis signal appears to comprise a late infectious uveitis shared by most T-cell-redirecting bispecific antibodies examined and an early immune-mediated uveitis that showed a signal only with elranatamab. These hypothesis-generating findings support prompt ophthalmological assessment of new visual symptoms and exclusion of cytomegalovirus retinitis before corticosteroids are started.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Medicine, Danbury Hospital, Zucker School of Medicine at Hofstra/Northwell, Danbury, CT, USA"
  ],
  "article_type": "PUBLISHAHEADOFPRINT",
  "arxiv": null,
  "author_total": 2,
  "authors": [
    {
      "name": "Y. Wang"
    },
    {
      "affs": [
        0
      ],
      "name": "Y. Guo"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/ey9b9kwn4rdr5.bib",
  "cited_by": 0,
  "doi": "10.64898/2026.09.29.26364283",
  "fulltext_url": "https://www.medrxiv.org/content/10.64898/2026.09.29.26364283v1.full",
  "id": "ey9b9kwn4rdr5",
  "issns": [],
  "landing_url": "https://www.medrxiv.org/content/10.64898/2026.09.29.26364283v1",
  "language": null,
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "medrxiv",
      "hematology"
    ],
    [
      "openalex",
      "3005|Pharmacovigilance and Adverse Drug Reactions"
    ]
  ],
  "openalex": "W7214957508",
  "pdf_url": "https://www.medrxiv.org/content/10.64898/2026.09.29.26364283v1.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-09-29",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/ey9b9kwn4rdr5.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:48Z",
      "native_id": "10.64898/2026.09.29.26364283",
      "source": "medrxiv",
      "url": "https://www.medrxiv.org/content/10.64898/2026.09.29.26364283v1"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:3005|Pharmacovigilance and Adverse Drug Reactions",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Uveitis with teclistamab and elranatamab: infection or inflammation?",
  "title_text": "Uveitis with teclistamab and elranatamab: infection or inflammation?",
  "type": "preprint",
  "updated_at": "2026-10-30T12:19:48Z",
  "url": "https://research.draconitic.com/paper/ey9b9kwn4rdr5",
  "venue": "medRxiv",
  "versions": []
}