尼达尼布治疗特发性肺纤维化患者的长期疗效：来自 TOMORROW 试验及其开放标签扩展研究的结果。
Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension.
机构信息
National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK.
Center for Interstitial and Rare Lung Diseases, Department of Pneumology, Thoraxklinik, University of Heidelberg, and Translational Lung Research Center Heidelberg, German Center for Lung Research Germany, Heidelberg, Germany.
出版信息
Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.
The TOMORROW trial of nintedanib comprised a randomised, placebo-controlled, 52-week period followed by a further blinded treatment period and an open-label extension. We assessed outcomes across these periods in patients randomised to nintedanib 150 mg twice daily or placebo at the start of TOMORROW. The annual rate of decline in FVC was -125.4 mL/year (95% CI -168.1 to -82.7) in the nintedanib group and -189.7 mL/year (95% CI -229.8 to -149.6) in the comparator group. The adverse event profile of nintedanib remained consistent throughout the studies. These results support a benefit of nintedanib on slowing progression of idiopathic pulmonary fibrosis beyond 52 weeks.
尼达尼布的 TOMORROW 试验包括随机、安慰剂对照的 52 周治疗期，随后是进一步的双盲治疗期和开放标签扩展期。我们评估了在 TOMORROW 开始时随机分配到尼达尼布 150mg 每日两次或安慰剂的患者在这些时期的结局。尼达尼布组的 FVC 年下降率为-125.4mL/年（95%CI-168.1 至-82.7），而对照组为-189.7mL/年（95%CI-229.8 至-149.6）。尼达尼布的不良事件谱在整个研究中保持一致。这些结果支持尼达尼布在 52 周以上减缓特发性肺纤维化进展的益处。
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