Insights from the German Compassionate Use Program of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis
Insights from the German Compassionate Use Program of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis
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DOI：
10.1159/000448288
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发表时间：
2016-01-01
期刊：
影响因子：
3.7
通讯作者：
Prasse, Antje
中科院分区：
文献类型：
--
作者：
Bonella, Francesco;Kreuter, Michael;Prasse, Antje
背景：尼达尼布被批准用于治疗特发性肺纤维化（IPF），并已被证明通过减少每年肺功能下降来减缓疾病进展。目的：评估在德国（9个中心）的一个同情使用项目（CUP）中接受尼达尼布治疗的大型IPF患者队列的结果。方法：患者（>= 40岁）需要确诊IPF，强迫肺活量(FVC) >= 50%预测（pred）和一氧化碳弥散量（DLCO） 30-79%预测。也没有资格接受吡非尼酮治疗。记录截至2015年7月的临床数据、肺功能检查和不良事件。结果：62例中度IPF患者（男48例/女14例）（FVC 64 +/- 17%）。和DLCO 40 +/- 10%（发生率）)用尼达尼布治疗。77%的患者改用吡非尼酮（平均治疗持续时间14 +/- 2个月），主要是由于疾病进展（FVC平均下降7.4 +/- 3%）。服用尼达尼布前6个月)。尼达尼布治疗开始于IPF诊断后69 +/- 29个月，平均治疗时间为8 +/- 4个月。大多数患者（63%）在治疗开始6个月后病情稳定（疾病进展患者FVC平均下降3 +/- 1 vs -17 +/- 2%， p < 0.01）。最常见的不良事件是腹泻（63%）和体重减轻（50%）。34%的病例减少了剂量，10%的病例停止了治疗。结论：尼达尼布治疗通常耐受性良好，并且在大多数非首次治疗的CUP环境中，大多数IPF患者与FVC稳定相关。我们的数据与之前发表的数据一致。(C) 2016，作者：s . Karger AG，巴塞尔出版
Background: Nintedanib is approved for the treatment of idiopathic pulmonary fibrosis(IPF) and has been shown to slow disease progression by reducing annual lung function decline. Objective: To evaluate the results of a large cohort of IPF patients treated with nintedanib within a compassionate use program(CUP) in Germany(9 centers). Methods: Patients ( >= 40 years) were required to have a confirmed diagnosis of IPF, a forced vital capacity(FVC) >= 50% predicted ( pred.) and a carbon monoxide diffusing capacity(DLCO) 30-79% pred. and not to be eligible for pirfenidone treatment. Clinical data, pulmonary function tests and adverse events were recorded up to July 2015. Results: Sixty-two patients (48 male/14 female) with moderate IPF (FVC 64 +/- 17% pred. and DLCO 40 +/- 10% pred.) were treated with nintedanib. 77% of patients switched from pirfenidone (mean treatment duration 14 +/- 2 months) mostly due to disease progression (mean decline in FVC 7.4 +/- 3% pred. in the 6 months prior to nintedanib intake). Initiation of nintedanib treatment occurred 69 +/- 29 months after IPF diagnosis, and mean treatment duration was 8 +/- 4 months. Most patients (63%) stabilized 6 months after treatment start (mean FVC decline 3 +/- 1 vs. -17 +/- 2% in patients with disease progression; p < 0.01). The most common adverse events were diarrhea (63%) and weight loss (50%). Dose reduction occurred in 34% of cases and treatment discontinuation in 10%. Conclusion: Nintedanib treatment was generally well tolerated and was associated with FVC stabilization in the majority of IPF patients in this CUP setting where most patients were not treatment naive. Our data are in agreement with the previously published data. (C) 2016 The Author(s) Published by S. Karger AG, Basel