Systemic sclerosis & Raynaud's
Nintedanib in systemic sclerosis-associated interstitial lung disease: real-world cohort study on tolerability and discontinuation
Authors' conclusion
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.
Study context
- Population
- SSc-ILD patients receiving nintedanib (mean age 56.5±13.8 years, 22% male; 76% on 150 mg twice daily, remainder 100 mg twice daily; 86% on mycophenolate)
- Participants
- 63 patients
- Outcome
- Tolerability and treatment-related interruptions of nintedanib
Methodological detailsmulticentre, real-world, multivariable logistic regression, Cox regression
- Multicentre
- Real-world
- Multivariable logistic regression
- Cox regression
Main finding
As reported in the abstract
Nintedanib interruptions · median 22.2-month follow-up (95% CI 18.1-26.2)
- Patients with nintedanib interruptions
- 51%
- Older age independently associated with interruption
- p< 0.03
- BMI <18.5 kg/m² independently associated with interruption
- p=0.024
Observational data: associations, not effects.
Further findings
- Permanent discontinuation
- 20.6%
- No significant predictors identified
Safety
Patient-reported reasons for treatment interruption
- Diarrhoea
- 33.3%
- Nausea/vomiting
- 20.6%
- Weight loss
- 9.5%
- Reflux
- 1.6%
Weight loss, 12±6 months after vs preceding 12±6 months before initiation
- Mean weight loss after initiation
- 2.05 kg
- Weight loss before initiation
- 1.09 kg
- Significantly greater after initiation
- P = 0.001
- Wilcoxon signed-rank test
Original publication
Nintedanib in systemic sclerosis-associated interstitial lung disease: real-world cohort study on tolerability and discontinuation. Clin Exp Rheumatol. Published 25 August 2025. doi:10.
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