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/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. JF - RMD Open TI - Effect of nintedanib in patients with systemic sclerosis-associated interstitial lung disease and risk factors for rapid progression ER -