Full Papers
Nintedanib in systemic sclerosis-associated interstitial lung disease: real-world cohort study on tolerability and discontinuation
P. Kaenmuang1, N.R. Goldman2, A. Srirangan3, F. Danzo4, W.-H. Yip5, A. Taki6, S. Boreland7, B. Vitri8, C.J. Stock9, C.P. Denton10, A.U. Wells11, V.H. Ong12, P. Sestini13, E.A. Renzoni14
- Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London; Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, UK; and Respiratory and Respiratory Critical Care Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand. punchalee.k@psu.ac.th
- Division of Medicine, Centre for Rheumatology, University College London, UK.
- Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK; and Post Graduate Institute of Medicine, Colombo, Sri Lanka.
- Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK; and Department of Biomedical and Clinical Sciences (DIBIC), Università degli Studi di Milano, Italy.
- Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK; and Department of Medicine and Therapeutics, Prince of Wales Hospital, Hong Kong.
- Department of Pharmacy, Royal Free Hospital, Royal Free London NHS Foundation Trust, London, UK.
- Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK.
- Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London, UK.
- Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London; and Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, UK.
- Division of Medicine, Centre for Rheumatology, University College London, UK.
- Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London; and Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, UK.
- Division of Medicine, Centre for Rheumatology, University College London, UK.
- Department of Medical and Surgical Sciences and Neurosciences, University of Siena, Italy.
- Interstitial Lung Disease Unit, Royal Brompton Hospital, Guy’s and St Thomas’ National Health Service Foundation Trust, London; and Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, UK.
CER19237
Full Papers
PMID: 41758543 [PubMed]
Received: 25/08/2025
Accepted : 10/11/2025
In Press: 23/02/2026
Abstract
OBJECTIVES:
Nintedanib slows progression of systemic sclerosis-associated interstitial lung disease (SSc-ILD), but its tolerability in this patient group is a potential concern.
METHODS:
This multicentre study evaluated tolerability and treatment-related interruptions in SSc-ILD patients receiving nintedanib. Factors associated with interruption were analysed by logistic regression, with multivariable adjustment for potential confounders. Fisher’s exact test was used when complete separation precluded logistic regression. Cox regression assessed time to first interruption. Weight changes before and after treatment were compared using the Wilcoxon signed-rank test.
RESULTS:
Among 63 patients (mean age 56.5±13.8 years, 22% male), 76% received nintedanib 150 mg twice daily, the remainder 100 mg twice daily; 86% were on mycophenolate. Over a median 22.2-month follow-up (95% CI 18.1-26.2), 51% experienced nintedanib interruptions. Patient-reported reasons for treatment interruption included diarrhoea (33.3%), nausea/vomiting (20.6%), weight loss (9.5%) and reflux (1.6%). Older age (p< 0.03) and BMI <18.5 kg/m2 (p=0.024) were independently associated with interruption. BMI <18.5 kg/m2 was also independently linked to shorter time to interruption. Permanent discontinuation occurred in 20.6%, with no significant predictors identified. Weight loss in the 12±6 months after treatment initiation (mean 2.05 kg) was significantly greater than in the preceding 12±6 months (1.09 kg) (p=0.001).
CONCLUSIONS:
Adverse effects frequently led to treatment interruptions in SSc-ILD patients. Older age and lower BMI were predictors of interruption, while no clear predictors of permanent discontinuation were identified. Most patients resumed treatment, highlighting the need for close monitoring and supportive care to manage side effects and maintain treatment continuity.
