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

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 enrol...

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Main Authors: Khanna, Dinesh (Author) , Maher, Toby M. (Author) , Volkmann, Elizabeth R. (Author) , Allanore, Yannick (Author) , Smith, Vanessa (Author) , Assassi, Shervin (Author) , Kreuter, Michael (Author) , Hoffmann-Vold, Anna-Maria (Author) , Kuwana, Masataka (Author) , Stock, Christian (Author) , Alves, Margarida (Author) , Sambevski, Steven (Author) , Denton, Christopher P. (Author)
Format: Article (Journal)
Language:English
Published: February 16, 2023
In: RMD Open
Year: 2023, Volume: 9, Pages: 1-6
ISSN:2056-5933
DOI:10.1136/rmdopen-2022-002859
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1136/rmdopen-2022-002859
Verlag, lizenzpflichtig, Volltext: https://rmdopen.bmj.com/content/9/1/e002859
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Author Notes:Dinesh Khanna, Toby M. Maher, Elizabeth R. Volkmann, Yannick Allanore, Vanessa Smith, Shervin Assassi, Michael Kreuter, Anna-Maria Hoffmann-Vold, Masataka Kuwana, Christian Stock, Margarida Alves, Steven Sambevski, Christopher P. Denton
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Summary: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.
Item Description:Gesehen am 23.03.2023
Physical Description:Online Resource
ISSN:2056-5933
DOI:10.1136/rmdopen-2022-002859