Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Departments of Medicine and Dermatology, Division of Immunology and Rheumatology, Stanford University School of Medicine, Stanford, CA, USA.
Respir Investig. 2021 Mar;59(2):252-259. doi: 10.1016/j.resinv.2020.10.005. Epub 2020 Nov 19.
In the SENSCIS trial in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) (mL/year) over 52 weeks by 44% in comparison with placebo, with manageable adverse events in most patients. We analyzed the efficacy and safety of nintedanib in patients of Asian race.
Patients with SSc-ILD were randomized to receive nintedanib or placebo. The outcomes over 52 weeks were analyzed in Asian versus non-Asian patients.
Of the 288 patients in each treatment group, 62 (21.5%) in the nintedanib group and 81 (28.1%) in the placebo group were Asian; 90.2% of the Asian patients were enrolled in Asian countries. In the placebo group, the rate of FVC decline over 52 weeks was consistent between Asian and non-Asian patients (-99.9 and -90.6 mL/year, respectively). The effect of nintedanib on reducing the rate of FVC decline over 52 weeks was consistent between Asian (difference, 44.3 mL/year [95% CI: -32.8, 121.4]) and non-Asian patients (difference, 39.0 mL/year [95% CI: -5.1, 83.1]) (treatment-by-time-by-subgroup interaction, p = 0.91). Diarrhea was the most frequent adverse event and was reported in similar proportions of Asian and non-Asian patients in the nintedanib group (80.6% and 74.3%, respectively) and placebo group (28.4% and 32.9%, respectively).
In patients with SSc-ILD, nintedanib had a consistent benefit on slowing the progression of SSc-ILD in Asian and non-Asian patients, with a similar adverse event profile.
ClinicalTrials.gov NCT02597933.
在系统性硬化症相关性间质性肺病（SSc-ILD）患者的 SENSCIS 试验中，尼达尼布与安慰剂相比，可使用力肺活量（FVC）（mL/年）在 52 周内的下降率降低 44%，大多数患者的不良反应可耐受。我们分析了尼达尼布在亚洲人种患者中的疗效和安全性。
将 SSc-ILD 患者随机分为尼达尼布或安慰剂组。分析了 52 周时的治疗结果，并比较了亚洲与非亚洲患者的差异。
每组 288 例患者中，尼达尼布组有 62 例（21.5%）、安慰剂组有 81 例（28.1%）为亚洲人；90.2%的亚洲患者来自亚洲国家。安慰剂组中，亚洲患者与非亚洲患者的 FVC 下降率在 52 周内是一致的（分别为-99.9 和-90.6 mL/年）。尼达尼布对降低 FVC 下降率的作用在亚洲患者（差异为 44.3 mL/年[95%CI：-32.8，121.4]）和非亚洲患者（差异为 39.0 mL/年[95%CI：-5.1，83.1]）中是一致的（治疗-时间-亚组交互作用，p=0.91）。腹泻是最常见的不良反应，尼达尼布组亚洲患者和非亚洲患者的报告比例相似（分别为 80.6%和 74.3%），安慰剂组的报告比例也相似（分别为 28.4%和 32.9%）。
在 SSc-ILD 患者中，尼达尼布可一致延缓 SSc-ILD 的进展，在亚洲患者和非亚洲患者中的疗效一致，不良反应谱相似。
ClinicalTrials.gov NCT02597933。
