Division of Rheumatology, University of Texas McGovern Medical School, Houston, TX, USA.
Pacific Coast Dermatology and Wellness Center, Redwood City, CA, USA.
Clin Exp Rheumatol. 2023 Aug;41(8):1713-1719. doi: 10.55563/clinexprheumatol/trcv91. Epub 2023 Aug 3.
The SENSCIS trial of nintedanib versus placebo is the largest trial conducted to date in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). This trial enrolled 576 patients with an extent of fibrotic ILD on high-resolution computed tomography of >10%. Median time since first non-Raynaud symptom was 3.4 years. Almost half of the patients were receiving a stable dose of mycophenolate at baseline. Key findings of the trial included that at baseline, despite having significant lung fibrosis on HRCT and impairment in lung function, 20% of the patients did not have cough and 30% did not have dyspnoea. Over 52 weeks, a marked decline in forced vital capacity (FVC) was observed (-112.0 mL/year in patients with diffuse cutaneous SSc [dcSSc] and -74.5 mL/year in patients with limited cutaneous SSc [lcSSc] in the placebo group). Loss of FVC was associated with an increased risk of SSc-related hospitalisation or death. Although certain subgroups of patients were at higher risk of progression, it was not possible to make a robust prediction of FVC decline based on baseline characteristics. The relative effect of nintedanib versus placebo on reducing the rate of FVC decline was consistent across subgroups based on factors including anti-topoisomerase I antibody (ATA) status, dcSSc vs. lcSSc, and use of mycophenolate at baseline. The side-effects of nintedanib were mainly gastrointestinal events, particularly diarrhoea. Nintedanib did not have a significant effect on skin fibrosis or health-related quality of life. Overall, the results of the SENSCIS trial support the importance of prompt identification and treatment of SSc-ILD and the consideration of nintedanib as a treatment option.
尼达尼布治疗系统性硬化症相关间质性肺病（SSc-ILD）的 SENSCIS 试验是迄今为止在该疾病患者中进行的最大规模试验。该试验纳入了 576 名高分辨率计算机断层扫描（HRCT）显示存在 >10%纤维化间质性肺病的患者。从首发非雷诺现象至入组中位时间为 3.4 年。近半数患者在基线时接受麦考酚酯稳定剂量治疗。该试验的主要发现包括，尽管 HRCT 显示存在显著肺纤维化且肺功能受损，但基线时仍有 20%的患者无咳嗽，30%的患者无呼吸困难。52 周时，用力肺活量（FVC）明显下降（弥漫性皮肤型 SSc[dcSSc]患者为-112.0mL/年，局限性皮肤型 SSc[lcSSc]患者为-74.5mL/年）。FVC 下降与 SSc 相关住院或死亡风险增加相关。虽然某些亚组患者进展风险更高，但基于基线特征，无法对 FVC 下降进行可靠预测。尼达尼布与安慰剂相比，降低 FVC 下降率的效果在基于抗拓扑异构酶 I 抗体（ATA）状态、dcSSc 与 lcSSc、基线时是否使用麦考酚酯等因素的各亚组中一致。尼达尼布的副作用主要为胃肠道事件，尤其是腹泻。尼达尼布对皮肤纤维化或健康相关生活质量无显著影响。总体而言，SENSCIS 试验结果支持及早发现和治疗 SSc-ILD 的重要性，以及将尼达尼布作为治疗选择的考虑。
