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Nintedanib in systemic sclerosis-associated interstitial lung disease (ILD)
ILD is a common complication of systemic sclerosis, conveying a considerable impact on morbidity and mortality. Nintedanib is approved for clinical use in idiopathic pulmonary fibrosis (IPF), where it has been shown to significantly reduce forced vital capacity (FVC) decline. The Safety and Efficacy of Nintedanib in Systemic Sclerosis (SENSCIS) trial (NEJM 2019;380:2518) used a randomised, double-blind placebo-controlled trial design to assess the impact of nintedanib on the annual rate of decline of FVC in patients with systemic sclerosis-associated ILD . The trial randomised 580 patients with scleroderma and ILD on high-resolution CT, to either placebo or nintedanib treatment. The nintedanib-treated group demonstrated a significantly reduced rate of decline of FVC of −52.4 mL/year compared with −93.3 mL/year in the placebo group (Δ41 mL/year, 95% CI 3 to 79 mL/year, p=0.04). However, there was no benefit observed in patient-reported outcomes, the St. George’s Respiratory Questionnaire (SGRQ) or modified Rodnan skin scores. Reports of diarrhoea were higher in the nintedanib group (75.7% vs 31.6%), and although the adverse events profiles were similar discontinuation rates were higher in the nintedanib group (16% v 9%). The …
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Commissioned; internally peer reviewed.
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