{
  "abstract": "Background and Importance Ipilimumab–nivolumab combination has reshaped advanced melanoma management, improving survival. Nevertheless, dual checkpoint blockade entails a high incidence of immune-related adverse events (irAEs). Early identification and coordinated management are crucial to balance efficacy and safety, where hospital pharmacists play an essential role in toxicity monitoring and optimisation.Aim and Objectives To characterise the incidence, type, severity, and management of irAEs in melanoma patients receiving ipilimumab–nivolumab therapy.Material and Methods A retrospective observational study was conducted including melanoma patients who initiated 3 mg/kg ipilimumab + 1 mg/kg nivolumab therapy between January 2021 and July 2025. Data were retrieved from electronic health records. Variables collected demographic data (age, sex, body weight), disease stage, prior therapy, number of cycles, and Eastern Cooperative Oncology Group (ECOG) score. Toxicities were classified according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, recording grade, time to onset, management strategy and hospitalisations. Results are expressed as median (interquartile range).Results Thirty-six patients were included (58.3% male; median age 57.5 (48–69.5) years; median bodyweight 66.4 (57–73.5) kg). Median disease stage IV (4–4), first-line treatment (1–1), median two cycles (1–4), and ECOG 1 (1–2).Overall, 64.7% (n=24) developed at least one irAE, and 55.6% (n=20) developed grade ≥3 toxicity comprising hepatitis (n=10), colitis (n=4), pneumonitis (n=2), encephalitis (n=1), acute polyradiculopathy (n=1), bilateral neurosensory retinal detachment (n=1), and severe rash (n=1). Median onset time was 4 weeks (2.75–8.25). Twenty patients required corticosteroids; three mycophenolate mofetil, three infliximab, one vedolizumab, and one tocilizumab. Treatment interruption occurred in 20 patients due to irAE and four due to non-irAE causes; 12 switched to nivolumab monotherapy and eight underwent regimen changes. Twenty-five hospitalisations were recorded, 20 (80%) irAE-related. Most events resolved with immunosuppressive therapy, with no treatment-related deaths.Conclusion and Relevance Ipilimumab–nivolumab combination in real-world practice was associated with a high incidence of irAEs, consistent with pivotal clinical trials. Early recognition and appropriate multidisciplinary management–where hospital pharmacists play a crucial role–are essential to optimise therapeutic outcomes, ensure treatment continuity, and minimise complications. Further multicentre studies are warranted to consolidate these findings and to develop evidence-based strategies for toxicity prevention and monitoring.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "JM Montes Gómez"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "E González-Haba Peña"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "MA Lucena Campillo"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "D Samitier Samitier"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "G Domínguez Chaparro"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "JL Revuelta Herrero"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "MP Montero Antón"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "S Del Barrio Buesa"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "C Jiménez Villarón"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "A Herranz Alonso"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Hospital Pharmacy, Madrid, Spain"
      ],
      "name": "M Sanjurjo Saez"
    }
  ],
  "title": "4CPS-121 Beyond efficacy: real-world evaluation of immune-related toxicities in melanoma patients receiving ipilimumab–nivolumab combination",
  "uid": "bb9d1f4e-c81b-5b35-a2ac-f339aae199ad"
}