{
  "abstract": "BackgroundFive biologics target sequential nodes of the type 2 (T2) inflammatory axis in severe asthma and have each been anecdotally linked to eosinophilic or paradoxical inflammatory adverse events. Whether these reflect a class effect or drug-specific signatures is untested.\n\nMethodsWe performed a case-noncase disproportionality analysis of FAERS, 2022-2024. Asthma-indication reports naming tezepelumab, dupilumab, mepolizumab, benralizumab, or omalizumab as primary suspect were compared against the pooled other four (active-comparator design) across 7 pre-specified eosinophilic, vasculitic (including EGPA), cutaneous, and ocular outcomes. A signal was robust if the reporting odds ratio (ROR) 95% CI lower bound exceeded 1 and a Bayesian criterion was also met.\n\nResultsAmong 50,360 reports (dupilumab n=29,652; mepolizumab n=8,846; omalizumab n=5,484; benralizumab n=4,372; tezepelumab n=2,006), benralizumab showed robust signals for EGPA (ROR 5.06), vasculitis (ROR 4.60), and peripheral eosinophilia (ROR 1.80). Mepolizumab showed a robust vasculitis signal (ROR 1.85); its similarly sized EGPA association narrowly missed the robustness criterion despite significance after correction for multiple testing. Dupilumab showed no EGPA/vasculitis excess but a robust ocular-inflammation signal (ROR 7.81). Tezepelumab and omalizumab showed no robust signal in any domain. EGPA/vasculitis onset occurred earlier after dupilumab (median 20-44 days) than anti-IL-5-axis agents (median 195-550 days; p[≤]0.012); mepolizumabs signal did not reproduce over the full 2015-2024 window (calendar-time confounding).\n\nConclusionFAERS active-comparator analysis reveals drug-specific, not class-uniform, adverse-event reporting patterns: anti-IL-5-axis agents disproportionately report EGPA/vasculitis, and dupilumab disproportionately reports ocular inflammation with markedly earlier onset. These hypothesis-generating signals cannot establish causality and require confirmation through case-level or comparative pharmacoepidemiological studies.",
  "abstract_shown": true,
  "affiliations": [
    "Cairo University - Faculty of Medicine, Kasr Al Ainy, Cairo, Egypt"
  ],
  "article_type": "PUBLISHAHEADOFPRINT",
  "arxiv": null,
  "author_total": 4,
  "authors": [
    {
      "name": "A. C. Iancu"
    },
    {
      "affs": [
        0
      ],
      "name": "M. Kobtan"
    },
    {
      "name": "N. Soliman"
    },
    {
      "name": "S. Abdellatif"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/cg4wckkt4xedp.bib",
  "cited_by": 0,
  "doi": "10.64898/2026.09.21.26363575",
  "fulltext_url": "https://www.medrxiv.org/content/10.64898/2026.09.21.26363575v1.full",
  "id": "cg4wckkt4xedp",
  "issns": [],
  "landing_url": "https://www.medrxiv.org/content/10.64898/2026.09.21.26363575v1",
  "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",
      "allergy and immunology"
    ],
    [
      "openalex",
      "3005|Pharmacovigilance and Adverse Drug Reactions"
    ]
  ],
  "openalex": "W7214024551",
  "pdf_url": "https://www.medrxiv.org/content/10.64898/2026.09.21.26363575v1.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-09-21",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/cg4wckkt4xedp.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:10Z",
      "native_id": "10.64898/2026.09.21.26363575",
      "source": "medrxiv",
      "url": "https://www.medrxiv.org/content/10.64898/2026.09.21.26363575v1"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:3005|Pharmacovigilance and Adverse Drug Reactions",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Divergent Eosinophilic and Paradoxical Inflammatory Adverse-Event Signatures Across Five Type 2 Asthma Biologics: A FAERS Active-Comparator Disproportionality Analysis",
  "title_text": "Divergent Eosinophilic and Paradoxical Inflammatory Adverse-Event Signatures Across Five Type 2 Asthma Biologics: A FAERS Active-Comparator Disproportionality Analysis",
  "type": "preprint",
  "updated_at": "2026-10-30T12:19:10Z",
  "url": "https://research.draconitic.com/paper/cg4wckkt4xedp",
  "venue": "medRxiv",
  "versions": []
}