
Faculty, Staff and Student Publications
Publication Date
2-1-2023
Journal
RMD Open
Abstract
Objective: To 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.
Methods: The 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 ≥330×109/L) or significant skin fibrosis (modified Rodnan skin score (mRSS) 15-40 or mRSS ≥18) at baseline.
Results: In 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.
Conclusion: In 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.
Keywords
Humans, Fibrosis, Lung Diseases, Interstitial, Risk Factors, Scleroderma, Systemic, Autoimmune Diseases, Pulmonary Fibrosis, Scleroderma, Systemic, Therapeutics
DOI
10.1136/rmdopen-2022-002859
PMID
36796874
PMCID
PMC9936273
PubMedCentral® Posted Date
2-16-2023
PubMedCentral® Full Text Version
Post-print
Published Open-Access
yes
Included in
Internal Medicine Commons, Medical Sciences Commons, Musculoskeletal Diseases Commons, Rheumatology Commons