{
  "abstract": "Background Nintedanib slows progression of systemic sclerosis-associated interstitial lung disease (SSc-ILD), but its tolerability is a potential concern.Methods This multicenter study with patients followed up in specialist respiratory and rheumatology units evaluated tolerability and treatment-related interruption in SSc-ILD patients receiving nintedanib. Logistic regression identified factors associated with interruption, with multivariable adjustment for potential confounders. Fisher’s exact test was used when complete separation precluded logistic regression. Time to first treatment interruption was analysed by Cox regression. Wilcoxon signed-rank test was used to compare weight changes before and after treatment.Results Among 63 patients (mean age 56.5±13.8 years, 22% male), 76.2% received nintedanib 150 mg twice daily with the remainder 100 mg twice daily. Concomitant mycophenolate mofetil use and baseline gastrointestinal (GI) symptoms were reported in 85.7%. Baseline patient-reported GI symptoms after nintedanib included diarrhoea (14%), reflux (48%), and nausea/vomiting (32%). Over a median follow up of 22.2 months (95% CI 18.1–26.2), 51% of patients interrupted nintedanib due to diarrhoea (33%), nausea/vomiting (21%), reflux (2%), weight loss (9.5%), and abnormal liver function (5%) (multiple reasons allowed). Older age (p<0.03) and BMI <18.5 kg/m 2 (p=0.024) were independently associated with interruption. Patients with BMI <18.5 kg/m2 was also significantly linked to shorter time to interruption (figure 1), even after adjustment for FVC or CPI and demographic variables. Baseline GI symptoms and concurrent disease-modifying antirheumatic drugs used were not associated with interruption. Most patients who experienced interruption were able to restart treatment, either at reduced or full dose. Permanent discontinuation occurred in 22.2%, with no significant predictors. Mean weight loss over 12 (±6) months after initiation (2.05 kg) was significantly greater than that observed over the same period before treatment (1.09 kg) (p=0.001).Abstract P23 Figure 1Conclusion Among patients with SSc-ILD treated with nintedanib, adverse effects are common, and weight loss frequently led to treatment interruptions. Older age and lower BMI were significant predictors of interruption, while no clear predictors of permanent discontinuation were identified, such as baseline GI symptoms, larger studies are needed to confirm these findings. Most patients were able to resume treatment, underscoring the need for close monitoring with access to healthcare professional support.",
  "authors": [
    {
      "affiliations": [
        "Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK",
        "Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, London, UK",
        "Respiratory and Respiratory Critical Care Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand"
      ],
      "name": "P Kaenmuang"
    },
    {
      "affiliations": [
        "Division of Medicine, Centre for Rheumatology, University College London, London, UK"
      ],
      "name": "NR Goldman"
    },
    {
      "affiliations": [
        "Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK",
        "Post Graduate Institute of Medicine, Colombo, Sri Lanka"
      ],
      "name": "A Srirangan"
    },
    {
      "affiliations": [
        "Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK",
        "Department of Biomedical and Clinical Sciences (DIBIC), Università degli Studi di Milano, Milano, Italy"
      ],
      "name": "F Danzo"
    },
    {
      "affiliations": [
        "Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK",
        "Department of Medicine and Therapeutics, Prince of Wales Hospital, Sha Tin, New Territories, Hong Kong"
      ],
      "name": "W-H Yip"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Royal Free Hospital, Royal Free London NHS Foundation Trust, London, UK"
      ],
      "name": "A Taki"
    },
    {
      "affiliations": [
        "Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK"
      ],
      "name": "S Boreland"
    },
    {
      "affiliations": [
        "Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK"
      ],
      "name": "B Vitri"
    },
    {
      "affiliations": [
        "Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK",
        "Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, London, UK"
      ],
      "name": "CJW Stock"
    },
    {
      "affiliations": [
        "Division of Medicine, Centre for Rheumatology, University College London, London, UK"
      ],
      "name": "CP Denton"
    },
    {
      "affiliations": [
        "Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK",
        "Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, London, UK"
      ],
      "name": "AU Wells"
    },
    {
      "affiliations": [
        "Division of Medicine, Centre for Rheumatology, University College London, London, UK"
      ],
      "name": "VH Ong"
    },
    {
      "affiliations": [
        "Department of Medical and Surgical Sciences and Neurosciences, University of Siena, Siena, Italy"
      ],
      "name": "P Sestini"
    },
    {
      "affiliations": [
        "Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK",
        "Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, London, UK"
      ],
      "name": "EA Renzoni"
    }
  ],
  "title": "P23 Nintedanib in systemic sclerosis-associated interstitial lung disease: real-world multicenter cohort study on tolerability and discontinuation",
  "uid": "7bed5c6f-7303-56eb-812a-f817dda54a6d"
}