Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
APHP, Service de Pneumologie A, Hôpital Bichat, DHU FIRE, INSERM, Unité 1152, Université Paris Diderot, Paris, France.
Respir Med. 2019 Sep;156:20-25. doi: 10.1016/j.rmed.2019.08.002. Epub 2019 Aug 6.
We explored the impact of FVC decline on subsequent FVC decline and mortality in the INPULSIS trials of nintedanib in patients with IPF and their open-label extension, INPULSIS-ON.
Changes in FVC and mortality between weeks 24 and 52 of the INPULSIS trials were assessed in patients with an increase/no decline in FVC % predicted and with declines in FVC <10% and ≥10% predicted from baseline to week 24. Changes in FVC and mortality in the first year of INPULSIS-ON were assessed in patients treated with nintedanib in the preceding INPULSIS trial who did and did not have a decline in FVC ≥10% predicted at week 52.
The proportion of placebo-treated patients with decline in FVC ≥10% predicted between weeks 24 and 52 of INPULSIS was similar in patients with increase/no decline in FVC and with decline in FVC ≥10% predicted between baseline and week 24 (20.5% and 18.9%, respectively). Mortality between weeks 24 and 52 of INPULSIS was higher in patients with FVC decline ≥10% predicted than <10% predicted between baseline and week 24 (13.2% vs 3.8%). Among nintedanib-treated patients in INPULSIS who had decline in FVC ≥10% versus <10% predicted at week 52, 34.0% versus 21.4%, respectively, had decline in FVC ≥10% predicted in the first year of INPULSIS-ON. Mortality in the first year of INPULSIS-ON was 21.3% vs 5.7% in these groups, respectively.
Decline in FVC did not predict FVC decline but was associated with mortality in patients with IPF.
我们研究了在特发性肺纤维化（IPF）患者的尼达尼布 INPULSIS 试验及其开放标签扩展 INPULSIS-ON 中，用力肺活量（FVC）下降对随后的 FVC 下降和死亡率的影响。
在 INPULSIS 试验中，我们评估了 FVC 从基线至第 24 周增加/无下降和 FVC 下降＜10%和≥10%预测值的患者，在第 24 至 52 周 FVC 变化和死亡率；在 INPULSIS-ON 的第一年，我们评估了在前一个 INPULSIS 试验中接受尼达尼布治疗且在第 52 周 FVC 预测值下降≥10%的患者，以及无 FVC 预测值下降≥10%的患者的 FVC 变化和死亡率。
在 INPULSIS 的第 24 至 52 周，与 FVC 从基线至第 24 周增加/无下降的患者相比，安慰剂治疗的 FVC 预测值下降≥10%的患者比例相似（分别为 20.5%和 18.9%）；与 FVC 从基线至第 24 周下降＜10%的患者相比，FVC 预测值下降≥10%的患者在 INPULSIS 的第 24 至 52 周死亡率更高（分别为 13.2%和 3.8%）。在 INPULSIS 中接受尼达尼布治疗且在第 52 周 FVC 预测值下降≥10%和＜10%的患者中，分别有 34.0%和 21.4%在 INPULSIS-ON 的第一年 FVC 预测值下降≥10%；在这两组患者中，INPULSIS-ON 的第一年死亡率分别为 21.3%和 5.7%。
FVC 下降并不能预测 FVC 下降，但与 IPF 患者的死亡率相关。
