Effect of nintedanib in patients with systemic sclerosis-associated interstitial lung disease and risk factors for rapid progression

ObjectiveTo investigate the rate of decline in forced vital capacity (FVC), and the effect of nintedanib on the rate of decline in FVC, in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) who had risk factors for rapid decline in FVC.MethodsThe SENSCIS trial enrolled subjects with SSc and fibrotic ILD of >= 10% extent on high-resolution CT. The rate of decline in FVC over 52 weeks was analysed in all subjects and in those with early SSc (<18 months since first non-Raynaud symptom), elevated inflammatory markers (C reactive protein >= 6 mg/L and/or platelets >= 330x10(9)/L) or significant skin fibrosis (modified Rodnan skin score (mRSS) 15-40 or mRSS >= 18) at baseline.ResultsIn the placebo group, the rate of decline in FVC was numerically greater in subjects with <18 months since first non-Raynaud symptom (-167.8 mL/year), elevated inflammatory markers (-100.7 mL/year), mRSS 15-40 (-121.7 mL/year) or mRSS >= 18 (-131.7 mL/year) than in all subjects (-93.3 mL/year). Nintedanib reduced the rate of FVC decline across subgroups, with a numerically greater effect in patients with these risk factors for rapid FVC decline.ConclusionIn the SENSCIS trial, subjects with SSc-ILD who had early SSc, elevated inflammatory markers or extensive skin fibrosis had a more rapid decline in FVC over 52 weeks than the overall trial population. Nintedanib had a numerically greater effect in patients with these risk factors for rapid ILD progression.

Automated summary

This study investigated the rate of decline in forced vital capacity (FVC) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) and the effect of nintedanib on this decline. The results showed that patients with early SSc, elevated inflammatory markers, or extensive skin fibrosis had a more rapid decline in FVC, but nintedanib could slow down this decline.