{
  "abstract": "Background and Importance Nintedanib, a tyrosine kinase inhibitor with antifibrotic activity, is approved for idiopathic pulmonary fibrosis (IPF) and chronic progressive fibrosing interstitial lung diseases (ILD). Clinical trials demonstrated efficacy, while placebo-controlled studies showed gastrointestinal events, especially diarrhoea, as the most frequent adverse events (AEs). Real-world evidence on safety and persistence remains scarce. Describing AEs in therapy management is essential for optimising antifibrotic treatment.Aim and Objectives To evaluate the incidence, type and clinical impact of AEs associated with nintedanib and analyse treatment persistence in patients with IPF or ILD under routine practice.Material and Methods Retrospective observational study conducted in a tertiary hospital including all patients starting nintedanib for IPF or ILD between March 2015 and August 2025 with at least one follow-up. Demographics, lung function and treatment data (initial dose, dose reduction, interruption, withdrawal) were collected. AEs were classified by organ system (gastrointestinal, hepatic, cardiovascular, others) and specific AE (diarrhoea, weight loss, nausea, etc.). Persistence was described at 6, 12 and 24 months. Medians and interquartile ranges were used for quantitative variables; means for time to discontinuation and interruption.Results Thirty-nine patients were included (median age 72 [66–76], 69% male) with basal FVC 66% [56–84] and diffusing capacity of the lungs for carbon monoxide (DLCO) 41% [31–51].IPF was diagnosed in 72% of the patients and other ILDs in the 28%. Initial doses were 150 mg/12h for 92% and 100 mg/12h for 8%.Dose reduction was required in 38.5% (median time to reduction 182 [71–302] days), temporary interruption in 10.3% (mean time to interruption 59,8 and median time of interruption 62 [43,2–77] days), and discontinuation in 23.1% (mean time to discontinuation 349.8 days).Overall, 64.1% of the patients developed ≥1 AE: gastrointestinal in 46.2%, hepatic 12.8%, cardiovascular 2.6% and others. Classified by AE: diarrhoea represented 35.9%, weight loss 12.8%, nausea 10.3%, elevated liver enzymes 7.7%. Diarrhoea was the main AE causing reduction (22.2%) and toxicity-related withdrawal (66.7%). Treatment persistence at ≥6 months was 84.6%, at ≥12 months 74.4% and at ≥24 months 53.8%.Conclusion and Relevance Nintedanib showed frequent but manageable toxicities, mainly gastrointestinal. Diarrhoea was the main cause of dose modification and withdrawal. Results highlight the need for proactive AE management to optimise treatment persistence.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Universitari Mútua Terrassa, Hospital Pharmacy, Terrassa, Spain"
      ],
      "name": "I Vàzquez Majó"
    },
    {
      "affiliations": [
        "Hospital Universitari Mútua Terrassa, Hospital Pharmacy, Terrassa, Spain"
      ],
      "name": "M Oliver Cervelló"
    },
    {
      "affiliations": [
        "Hospital Universitari Mútua Terrassa, Hospital Pharmacy, Terrassa, Spain"
      ],
      "name": "B Tenas Rius"
    },
    {
      "affiliations": [
        "Hospital Universitari Mútua Terrassa, Hospital Pharmacy, Terrassa, Spain"
      ],
      "name": "C Garcia Navarro"
    },
    {
      "affiliations": [
        "Hospital Universitari Mútua Terrassa, Hospital Pharmacy, Terrassa, Spain"
      ],
      "name": "V Insensé Urbano"
    },
    {
      "affiliations": [
        "Hospital Universitari Mútua Terrassa, Hospital Pharmacy, Terrassa, Spain"
      ],
      "name": "J Nicolás Picó"
    }
  ],
  "title": "5PSQ-081 Nintedanib safety profile and treatment persistence in patients with fibrosing interstitial lung disease: a single-centre retrospective analysis",
  "uid": "f694bd32-c41f-5723-9923-2ed9d2447344"
}