{
  "abstract": "Background and Importance Summaries of drug characteristics of Immune Checkpoint Inhibitors (ICIs) include myositis, myocarditis and myasthenia gravis as adverse drug reactions (ADR). These drugs are increasingly being used in oncology. Since 2020, the rare but life-threatening myositis-myocarditis-myasthenia gravis overlap syndrome has been described in medical literature as an ADR of ICIs in which the three conditions appear simultaneously. Suspected ADR documented in FEDRA database provides a valuable resource for post-marketing pharmacovigilance assessment. After receiving four reports of this syndrome (two with mortal outcome) as a suspected ADR of different ICIs (nivolumab, pembrolizumab and nivolumab+ipilimumab) within 2 months in the regional Pharmacovigilance Centre, we decided to analyse the reports received for this ADR and these drugs in FEDRA.Aim and Objectives To analyse the outcome and reporting trend of myocarditis-myositis-myasthenia gravis overlap syndrome in reports of suspected ADR of nivolumab, pembrolizumab and ipilimumab in FEDRA and their correlation with those published in PubMed.Material and Methods We performed a descriptive study based on pharmacovigilance data retrieved from Individual Case Safety Reports identified in FEDRA since 2011, marketing year of ipilimumab, of suspected ADR reports for pembrolizumab, nivolumab and ipilimumab using MedDRA Preferred Terms: Myositis/autoimmune myositis/immune-mediated myositis and myocarditis/autoimmune myocarditis/immune-mediated myocarditis and myasthenia gravis/immune-mediated myasthenia gravis or myositis-myocarditis-myasthenia gravis overlap syndrome.We have also searched in Pubmed for published articles with the term myocarditis-myositis-myasthenia gravis overlap syndrome.Results Abstract 5PSQ-093 Table 1 DRUG (cases (mortal outcome)) 2011- 2019 2020 2021 2022 2023 2024 2025 Total Pembrolizumab 0 2(1) 0 2(2) 2(1) 2(1) 10(4) 18(9) Nivolumab 0 0 2(2) 2(2) Nivolumab+Ipilimumab 0 0 1(1) 1 1 5(1) 8(2) 28 (13) Abstract 5PSQ-093 Table 2 2020 2021 2022 2023 2024 2025 Total Number of Articles with the Term 2 4 2 7 6 16 37 Conclusion and Relevance Myositis-myocarditis-myasthenia gravis overlap syndrome is a rare but life-threatening emerging ADR to ICIs that should be taken into account by clinicians in the management of these treatments. Pharmacovigilance is crucial in identifying ADR and promoting patient safety and the rational use of medicines.The major limitation of pharmacovigilance is the underreporting of rare adverse events. There is an urgent need to encourage consumers and health care professionals to report suspected ADR to Pharmacovigilance National Systems.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Centro De Farmacovigilancia De Navarra, Departamento De Salud, Pamplona, Spain"
      ],
      "name": "C De Agapito Vicente"
    },
    {
      "affiliations": [
        "Centro De Farmacovigilancia De Navarra, Departamento De Salud, Pamplona, Spain"
      ],
      "name": "G Elizondo Rivas"
    },
    {
      "affiliations": [
        "Centro De Farmacovigilancia De Navarra, Departamento De Salud, Pamplona, Spain"
      ],
      "name": "C García Tinoco"
    },
    {
      "affiliations": [
        "Servicio De Farmacia, Hospital Universitario De Navarra, Pamplona, Spain"
      ],
      "name": "I Elcano Aguirre"
    },
    {
      "affiliations": [
        "Servicio De Farmacia, Hospital Universitario De Navarra, Pamplona, Spain"
      ],
      "name": "I Artieda Urdanoz"
    },
    {
      "affiliations": [
        "Servicio De Farmacia, Hospital Universitario De Navarra, Pamplona, Spain"
      ],
      "name": "L Moreno Compains"
    },
    {
      "affiliations": [
        "Servicio De Farmacia, Hospital Universitario De Navarra, Pamplona, Spain"
      ],
      "name": "B Tirapu Nicolás"
    }
  ],
  "title": "5PSQ-093 Myocarditis-myositis-myasthenia gravis overlap syndrome: an emerging severe adverse reaction among immune checkpoint inhibitors. Analysis of reports in the Spanish adverse reactions database (FEDRA)",
  "uid": "1ae1281c-3d68-504b-9591-f41461e6c203"
}