TY  - JOUR
AV  - public
ID  - discovery10165424
VL  - 9
KW  - Autoimmune Diseases
KW  -  Pulmonary Fibrosis
KW  -  Scleroderma
KW  -  Systemic
KW  -  Therapeutics
IS  - 1
SN  - 2056-5933
A1  - Khanna, Dinesh
A1  - Maher, Toby M
A1  - Volkmann, Elizabeth R
A1  - Allanore, Yannick
A1  - Smith, Vanessa
A1  - Assassi, Shervin
A1  - Kreuter, Michael
A1  - Hoffmann-Vold, Anna-Maria
A1  - Kuwana, Masataka
A1  - Stock, Christian
A1  - Alves, Margarida
A1  - Sambevski, Steven
A1  - Denton, Christopher P
N2  - 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.
PB  - BMJ
Y1  - 2023/02/16/
UR  - https://doi.org/10.1136/rmdopen-2022-002859
N1  - © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/
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JF  - RMD Open
TI  - Effect of nintedanib in patients with systemic sclerosis-associated interstitial lung disease and risk factors for rapid progression
ER  -