PT  - JOURNAL ARTICLE
AU  - Dinesh Khanna
AU  - Toby M Maher
AU  - Elizabeth R Volkmann
AU  - Yannick Allanore
AU  - Vanessa Smith
AU  - Shervin Assassi
AU  - Michael Kreuter
AU  - Anna-Maria Hoffmann-Vold
AU  - Masataka Kuwana
AU  - Christian Stock
AU  - Margarida Alves
AU  - Steven Sambevski
AU  - Christopher P Denton
TI  - Effect of nintedanib in patients with systemic sclerosis-associated interstitial lung disease and risk factors for rapid progression
AID  - 10.1136/rmdopen-2022-002859
DP  - 2023 Feb 01
TA  - RMD Open
PG  - e002859
VI  - 9
IP  - 1
4099  - http://rmdopen.bmj.com/content/9/1/e002859.short
4100  - http://rmdopen.bmj.com/content/9/1/e002859.full
SO  - RMD Open2023 Feb 01; 9
AB  - 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.To ensure independent interpretation of clinical study results and enable authors to fulfill their role and obligations under the ICMJE criteria, Boehringer Ingelheim grants all external authors access to relevant clinical study data. In adherence with the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete and other criteria are met. Researchers should use https://vivli.org/ to request access to study data and visit https://www.mystudywindow.com/msw/datasharing for further information.