{
  "abstract": "Objective: This study aimed to investigate the impact of vunakizumab on adverse events (AEs) in patients with moderate-to-severe plaque psoriasis.\n\nMethods: This exploratory post-hoc analysis used data from a phase III trial (NCT04839016). A total of 690 patients were included. The primary outcome was any AE occurrence during the 12-week induction treatment period.\n\nResults: The incidence of any AE during the induction period was 69.9%. No significant difference in the incidence of any AE was observed between the two groups [risk difference (RD): -2.6%; 95% confidence interval (CI): -9.8% to 4.6%]. Sensitivity analyses showed that vunakizumab was not an independent influencing factor for the occurrence of any AE [odds ratio (OR): 0.828; 95% CI: 0.574 to 1.193; P = 0.311]. At the system organ class (SOC) level, investigations, metabolic and nutritional disorders, infectious and parasitic diseases, and skin and subcutaneous tissue diseases had incidences of 31.9%, 26.7%, 18.0%, and 14.6%, respectively. At the preferred term (PT) level, incidences were 11.3% for hyperuricemia, 7.1% for elevated liver enzymes, and 5.1% for injection site reaction. At the SOC level, the incidence of skin and subcutaneous tissue diseases was lower in the vunakizumab group than in the placebo group (RD: -6.2%; 95% CI: -12.1% to -0.3%). At the PT level, the incidence of injection site reaction was higher in the vunakizumab group than in the placebo group (RD: 4.3%; 95% CI: 1.4% to 7.3%). Notably, after excluding psoriasis exacerbation, the association between vunakizumab and skin and subcutaneous tissue diseases was no longer significant.\n\nConclusion: Vunakizumab is not significantly associated with the occurrence of any AE or most selected AE categories in patients with moderate-to-severe plaque psoriasis, whereas vunakizumab is associated with a higher likelihood of injection site reaction and a lower likelihood of skin and subcutaneous tissue diseases. The observed lower incidence of skin and subcutaneous tissue diseases may largely reflect improved control of psoriasis rather than a specific safety benefit of vunakizumab.\n\nClinical trial registration: https://clinicaltrials.gov/ , identifier NCT04839016.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Dermatology, The Second Hospital of Dalian Medical University"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 3,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Zhendong Wei"
    },
    {
      "affs": [
        0
      ],
      "name": "Lu Xu"
    },
    {
      "affs": [
        0
      ],
      "name": "Aoxue Wang"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/828gaahx3hapf.bib",
  "cited_by": 0,
  "doi": "10.3389/fimmu.2026.1894231",
  "fulltext_url": "https://europepmc.org/articles/PMC13713518",
  "id": "828gaahx3hapf",
  "issns": [
    "1664-3224"
  ],
  "landing_url": "https://www.frontiersin.org/articles/10.3389/fimmu.2026.1894231/full",
  "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": [
    [
      "heading",
      "Clinical Trial"
    ],
    [
      "openalex",
      "2403|Psoriasis: Treatment and Pathogenesis"
    ]
  ],
  "openalex": "W7221798414",
  "pdf_url": "https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2026.1894231/pdf",
  "pmcid": "PMC13713518",
  "pmid": "42952621",
  "published": "2026-10-14",
  "publisher": "Frontiers Media SA",
  "ris": "https://research.draconitic.com/paper/828gaahx3hapf.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:17Z",
      "native_id": "10.3389/fimmu.2026.1894231",
      "source": "crossref",
      "url": "https://www.frontiersin.org/articles/10.3389/fimmu.2026.1894231/full"
    },
    {
      "first_seen": "2026-10-31T00:20:41Z",
      "native_id": "MED:42952621",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42952621"
    },
    {
      "first_seen": "2026-10-31T12:24:03Z",
      "native_id": "PMC13713518",
      "source": "pmc",
      "url": "https://doi.org/10.3389/fimmu.2026.1894231"
    }
  ],
  "subjects": [
    {
      "field": "biology",
      "origin": "openalex:2403|Psoriasis: Treatment and Pathogenesis",
      "subfield": "immunology"
    }
  ],
  "title": "Selected adverse events during the 12-week induction period of a phase III trial of vunakizumab: an exploratory post-hoc analysis",
  "title_text": "Selected adverse events during the 12-week induction period of a phase III trial of vunakizumab: an exploratory post-hoc analysis",
  "type": "peer-reviewed",
  "updated_at": "2026-11-01T12:21:10Z",
  "url": "https://research.draconitic.com/paper/828gaahx3hapf",
  "venue": "Frontiers in Immunology",
  "versions": []
}