尼达尼布对IPF的疗效、安全性和耐受性受2016 ATS 报告认同

德国殷格翰2016年5月19日电 /美通社/ -- 在美国胸科协会2016年会（ATS 2016）上报告的新数据分析，进一步补充了尼达尼布治疗特发性肺纤维化（IPF）的疗效和安全性特征。^1-4在ATS上勃林格殷格翰总共报告了12项与 IPF 相关的研究摘要，包括 INPULSIS^®试验的进一步分析。这些数据为尼达尼布在广泛患者中的临床获益提供了更多证据：

• 通过评价肺功能下降（用力肺活量［FVC］，下降>10%）和死亡的复合终点，表明尼达尼布可以延缓疾病进展。¹
• 尼达尼布可以延缓肺功能下降，这种作用不受基线时根据 GAP 分期（患者的性别、年龄或疾病的生理机制）测量的疾病严重程度的影响。⁴
• 根据 INPULSIS 试验的汇总数据，与安慰剂组相比，尼达尼布可以显著降低研究者首次报告急性加重的风险（作为严重不良事件上报）达43%。²
• 上市后监测的1年期数据（包括6700位接受尼达尼布治疗的患者的真实临床实践数据）进一步确认了尼达尼布在临床研究中观察到的安全性和耐受性特征。³

“IPF 病情进展具有多样化和不可预测的特点，但是随着时间延长，患者的肺功能都会逐渐地不可逆地下降，”芝加哥大学的医学教授，间质性肺病项目主管 Imre Noth 医生说。“正在进行的、对III期 INPULSIS 试验的分析及真实世界数据，提供了更多的证据支持尼达尼布的安全性和疗效。延缓病情进展是一个重要的治疗目标，这些数据支持IPF患者可以从治疗中获益，无论其疾病严重程度如何。”

汇总的III期 INPULSIS^®试验新分析表明：

• 尼达尼布显著降低疾病进展风险达40%（尼达尼布27.1%，对比安慰剂41.4%，p<0.0001），测量的指标是52周内肺功能恶化（FVC 绝对下降>10%）或死亡的复合终点。此外，分析表明根据基线时 FVC 定义的一系列患者，都一致出现疾病进展减慢。¹
• 各亚组的尼达尼布临床获益均一致。无论基线时患者的 GAP 分期（性别、年龄和疾病的生理机制）如何，尼达尼布都可以延缓肺功能下降。⁴参阅完整的摘要。
• 尼达尼布可以显著降低受试者作为严重不良事件上报的首次急性加重的风险43%（尼达尼布3.6%对比安慰剂6.1%；p=0.0476），作为确认的或疑似严重不良事件上报的急性加重风险下降70%（尼达尼布1.6%，对比安慰剂5%；p=0.0019）。作为严重不良事件报告的急性加重患者，其死亡风险高于作为非严重不良事件报告的急性加重患者。²
• 在上市后监测中收集到的6700多位接受尼达尼布治疗的美国患者1年期不良事件数据，包括真实世界数据，与关键性临床试验的数据一致。没有观察到新的安全性问题或非预期安全性信号。³ 
  

 “我们致力于推动科技进展以解决治疗方法有限的罕见病患者尚未满足的医疗需求，” 勃林格殷格翰呼吸治疗领域医学负责人William Mezzanotte 说。“迄今全球已有超过1万名患者接受过尼达尼布治疗，我们一直在努力通过我们的临床试验项目以及在真实世界临床实践中对尼达尼布的持续研究，深化对 IPF 的理解。”

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