National Heart and Lung Institute, Imperial College London and NIHR Clinical Research Facility, Royal Brompton Hospital, London, UK, and Keck School of Medicine, University of Southern California, Los Angeles.
University of Texas McGovern Medical School, Houston.
Arthritis Rheumatol. 2021 Apr;73(4):671-676. doi: 10.1002/art.41576. Epub 2021 Mar 8.
In the SENSCIS trial in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo. This study was undertaken to investigate the effects of nintedanib on categorical changes in FVC and other measures of ILD progression.
In post hoc analyses, we assessed the proportions of subjects with categorical changes in FVC % predicted at week 52 and the time to absolute decline in FVC of ≥5% predicted or death and absolute decline in FVC of ≥10% predicted or death.
A total of 288 subjects received nintedanib and 288 subjects received placebo. At week 52, in subjects treated with nintedanib and placebo, respectively, 55.7% and 66.3% had any decline in FVC % predicted, 13.6% and 20.1% had a decline in FVC of >5% to ≤10% predicted, and 3.5% and 5.2% had a decline in FVC of >10% to ≤15% predicted; 34.5% and 43.8% had a decrease in FVC of ≥3.3% predicted (proposed minimal clinically important difference [MCID] for worsening of FVC), while 23.0% and 14.9% had an increase in FVC of ≥3.0% predicted (proposed MCID for improvement in FVC). Over 52 weeks, the hazard ratio (HR) for an absolute decline in FVC of ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% confidence interval [95% CI] 0.66-1.06) (P = 0.14), and the HR for an absolute decline in FVC of ≥10% predicted was 0.64 (95% CI 0.43-0.95) (P = 0.029).
These results suggest that nintedanib has a clinically relevant benefit on the progression of SSc-ILD.
在系统性硬化症相关间质性肺病（SSc-ILD）患者的 SENSCIS 试验中，尼达尼布可使用力肺活量（FVC）下降率在 52 周时相对于安慰剂组降低 44%。本研究旨在探讨尼达尼布对 FVC 及其他间质性肺病进展评估指标的分类变化的影响。
在事后分析中，我们评估了第 52 周时 FVC 预测值的分类变化以及 FVC 绝对值下降≥5%预测值或死亡和 FVC 绝对值下降≥10%预测值或死亡的时间的比例。
共有 288 例患者接受尼达尼布治疗，288 例患者接受安慰剂治疗。第 52 周时，尼达尼布组和安慰剂组分别有 55.7%和 66.3%的患者 FVC 预测值出现任何下降，13.6%和 20.1%的患者 FVC 下降>5%至≤10%预测值，3.5%和 5.2%的患者 FVC 下降>10%至≤15%预测值；34.5%和 43.8%的患者 FVC 预测值下降≥3.3%（FVC 恶化的提议最小临床重要差异 [MCID]），而 23.0%和 14.9%的患者 FVC 预测值增加≥3.0%（FVC 改善的提议 MCID）。尼达尼布组和安慰剂组 FVC 绝对值下降≥5%预测值或死亡的风险比（HR）分别为 0.83（95%置信区间 [95%CI] 0.66-1.06）（P = 0.14）和 0.64（95%CI 0.43-0.95）（P = 0.029）。
这些结果表明，尼达尼布对 SSc-ILD 的进展具有临床相关的获益。
