Background

The efficacy of nintedanib in progressive fibrosing interstitial lung diseases (ILDs) was demonstrated in the randomised, double-blind, placebo-controlled INBUILD trial. This subgroup analysis evaluated the efficacy and safety of nintedanib in the Japanese population.

Methods

Patients with progressive fibrosing ILDs (evaluated by physicians within 24 months of screening) were randomised (1:1) to twice-daily 150-mg nintedanib or placebo; treatment continued until the last patient completed 52 weeks. The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks. Time-to-first acute ILD exacerbation or death and time-to-death up until the last patient had completed the week 52 visit were evaluated. This subgroup analysis included 108 Japanese patients.

Results

The adjusted annual rates of FVC decline (mL/year) over 52 weeks for Japanese patients were –148.31 (nintedanib) and –240.36 (placebo), adjusted difference: 92.05 (95% CI: –10.69–194.80) and for non-Japanese patients were –67.41 (nintedanib) and –177.65 (placebo), adjusted difference: 110.24 (95% CI: 64.97–155.52). No heterogeneity in treatment effect between Japanese and non-Japanese subgroups was observed (treatment-by-subgroup interaction, p=0.75). The risks of “acute exacerbation or death” (hazard ratio, 0.30 [95% CI: 0.10−0.91]) and mortality (hazard ratio, 0.54 [95% CI: 0.14−2.11]) in Japanese patients were numerically lower for nintedanib than placebo. There were no new or unexpected safety findings.

Conclusions

In Japanese patients, nintedanib slowed ILD progression, evidenced by a reduction in the annual rate of decline in FVC vs placebo. The efficacy and safety of nintedanib in Japanese patients were consistent with the overall INBUILD population.

ClinicalTrials.gov

NCT02999178 (21-Dec-2016.

中文翻译：

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尼达尼布在日本进行性纤维化间质性肺病患者中的疗效和安全性：随机、双盲、安慰剂对照、3 期 INBUILD 试验的亚组分析

背景

随机、双盲、安慰剂对照的 INBUILD 试验证明了尼达尼布对进行性纤维化间质性肺病 (ILD) 的疗效。该亚组分析评估了尼达尼布在日本人群中的疗效和安全性。

方法

患有进行性纤维化 ILD 的患者（在筛查后 24 个月内由医生评估）被随机分配（1:1）至每天两次 150 毫克尼达尼布或安慰剂组；治疗一直持续到最后一名患者完成 52 周。主要终点是 52 周内用力肺活量 (FVC) 的年下降率。评估第一次急性 ILD 恶化或死亡的时间以及直到最后一名患者完成第 52 周就诊的死亡时间。该亚组分析包括 108 名日本患者。

结果

日本患者 52 周内调整后的 FVC 年下降率（mL/年）分别为 –148.31（尼达尼布）和 –240.36（安慰剂），调整后差异：92.05（95% CI：–10.69–194.80）和非日本患者患者为–67.41（尼达尼布）和–177.65（安慰剂），调整后的差异：110.24（95% CI：64.97–155.52）。在日本和非日本亚组之间没有观察到治疗效果的异质性（治疗与亚组的相互作用，p=0.75）。日本患者的“急性加重或死亡”风险（风险比，0.30 [95% CI：0.10-0.91]）和死亡率（风险比，0.54 [95% CI：0.14-2.11]）在数值上低于尼达尼布组安慰剂。没有新的或意外的安全发现。

结论

在日本患者中，尼达尼布减缓了 ILD 的进展，与安慰剂相比，FVC 的年下降率有所降低。尼达尼布在日本患者中的疗效和安全性与整个 INBUILD 人群一致。

临床试验.gov

NCT02999178（2016 年 12 月 21 日。