Division of Rheumatology, Scleroderma Program, University of Michigan, Ann Arbor, Michigan, USA
Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
RMD Open. 2023 Feb;9(1). doi: 10.1136/rmdopen-2022-002859.
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.
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 ≥330×10/L) or significant skin fibrosis (modified Rodnan skin score (mRSS) 15-40 or mRSS ≥18) at baseline.
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.
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.
研究系统性硬皮病相关间质性肺病（SSc-ILD）患者用力肺活量（FVC）下降率，以及尼达尼布对 FVC 下降率的影响，这些患者存在 FVC 快速下降的危险因素。
SENSCIS 试验纳入了有 SSc 和高分辨率 CT 显示纤维化间质性肺病≥10%的患者。分析了所有患者和基线时有早期 SSc（首发非雷诺现象后＜18 个月）、炎症标志物升高（C 反应蛋白≥6mg/L 和/或血小板≥330×10/L）或明显皮肤纤维化（改良 Rodnan 皮肤评分（mRSS）15-40 或 mRSS≥18）的患者 52 周时 FVC 下降率。
在安慰剂组中，首发非雷诺现象后＜18 个月的患者（-167.8mL/年）、炎症标志物升高的患者（-100.7mL/年）、mRSS 15-40 的患者（-121.7mL/年）或 mRSS≥18 的患者（-131.7mL/年）FVC 下降率均高于所有患者（-93.3mL/年），且呈数值性增加。尼达尼布降低了 FVC 下降率，在这些有快速 FVC 下降危险因素的患者中，效果呈数值性增加。
在 SENSCIS 试验中，与整个试验人群相比，有早期 SSc、炎症标志物升高或广泛皮肤纤维化的 SSc-ILD 患者在 52 周时 FVC 下降更快。尼达尼布对这些有快速 ILD 进展危险因素的患者效果更明显。
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