Department of Rheumatology, Paris Cité University, APHP, Cochin Hospital, Paris, France.
Department of Medicine, University of Michigan, Ann Arbor, MI, USA.
Rheumatology (Oxford). 2024 Mar 1;63(3):639-647. doi: 10.1093/rheumatology/kead280.
To investigate the course of interstitial lung disease (ILD) and the effects of nintedanib in patients with limited cutaneous systemic sclerosis (lcSSc).
In the SENSCIS trial, patients with SSc-ILD were randomized to receive nintedanib or placebo. Patients who completed the SENSCIS trial were eligible to enter SENSCIS-ON, in which all patients received open-label nintedanib.
Among 277 patients with lcSSc treated in the SENSCIS trial, the rate (s.e.) of decline in forced vital capacity (FVC; ml/year) over 52 weeks was -74.5 (19.2) in the placebo group and -49.1 (19.8) in the nintedanib group (difference: 25.3 [95% CI -28.9, 79.6]). Among 249 patients with data at week 52, mean (s.e.) change in FVC at week 52 was -86.4 (21.1) ml in the placebo group and -39.1 (22.2) ml in the nintedanib group. Among 183 patients with lcSSc who participated in SENSCIS-ON and had data at week 52, mean (s.e.) change in FVC from baseline to week 52 of SENSCIS-ON was -41.5 (24.0) ml in patients who took placebo in the SENSCIS trial and initiated nintedanib in SENSCIS-ON and -45.1 (19.1) ml in patients who took nintedanib in the SENSCIS trial and continued it in SENSCIS-ON.
Patients with lcSSc may develop progressive fibrosing ILD. By targeting pulmonary fibrosis, nintedanib slows decline in lung function in patients with lcSSc and ILD.
ClinicalTrials.gov (https://clinicaltrials.gov), NCT02597933 and NCT03313180.
研究局限性皮肤型系统性硬皮病（lcSSc）患者间质性肺病（ILD）的病程及尼达尼布的疗效。
在 SENSCIS 试验中，SSc-ILD 患者被随机分配接受尼达尼布或安慰剂。完成 SENSCIS 试验的患者有资格进入 SENSCIS-ON，所有患者均接受尼达尼布开放标签治疗。
在 SENSCIS 试验中，277 例 lcSSc 患者中，安慰剂组和尼达尼布组在 52 周时用力肺活量（FVC；ml/年）下降率分别为 -74.5（19.2）和 -49.1（19.8）（差异：25.3 [95%CI -28.9，79.6]）。在 52 周时有数据的 249 例患者中，安慰剂组和尼达尼布组第 52 周时 FVC 的平均（s.e.）变化分别为-86.4（21.1）ml 和-39.1（22.2）ml。在参与 SENSCIS-ON 且在第 52 周时有数据的 183 例 lcSSc 患者中，SENSCIS-ON 基线至第 52 周时 FVC 的平均（s.e.）变化在 SENSCIS 试验中接受安慰剂且在 SENSCIS-ON 中开始接受尼达尼布治疗的患者为-41.5（24.0）ml，在 SENSCIS 试验中接受尼达尼布且在 SENSCIS-ON 中继续接受尼达尼布治疗的患者为-45.1（19.1）ml。
局限性皮肤型系统性硬皮病患者可能会发生进行性纤维化间质性肺病。通过靶向肺纤维化，尼达尼布可减缓局限性皮肤型系统性硬皮病和间质性肺病患者的肺功能下降速度。
ClinicalTrials.gov（https://clinicaltrials.gov），NCT02597933 和 NCT03313180。
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