Centre for Interstitial and Rare Lung Diseases, Department of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.
Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany.
Respiration. 2018;95(5):301-309. doi: 10.1159/000485933. Epub 2018 Feb 28.
Nintedanib, an oral tyrosine kinase inhibitor, has been shown to slow down the progression of idiopathic pulmonary fibrosis (IPF) in two randomised placebo-controlled trials by reducing the annual decline in forced vital capacity (FVC). However, real-world experience is limited.
To assess the efficacy and safety of nintedanib in a large cohort of patients treated at a tertiary referral site for interstitial lung diseases.
The records of patients with a confirmed diagnosis of IPF were reviewed. Full medical history, pulmonary function, and adverse events (AEs) were recorded from each clinic visit. Disease progression was defined as a reduction in FVC ≥5% and/or in diffusing capacity of the lung for carbon monoxide ≥15% according to recent publications. Only patients with a treatment duration ≥3 months were included in the efficacy evaluation.
A total of 64 patients were treated. Mean ± standard deviation (SD) FVC was 71 ± 21% predicted, and the mean time from diagnosis to initiation of nintedanib treatment was 23.8 months. Nearly half of patients (n = 30, 47%) had received prior pirfenidone treatment. The mean duration of follow-up was 11 months. At 6 months following initiation of nintedanib, 67% of the patients were stable. The mean ± SD change in percent predicted FVC from baseline was 0.2 ± 7.8% at 3 months, -1.3 ± 7.9% at 6 months, and -2.1 ± 9% at 9 months. Diarrhoea was the most common AE experienced by 33% of patients and was generally manageable.
The results from this real-world clinical setting support findings from previously conducted clinical trials and show that nintedanib is effective for the management of IPF and is associated with disease stabilisation. Nintedanib is generally well tolerated.
尼达尼布是一种口服酪氨酸激酶抑制剂，在两项随机安慰剂对照试验中，通过降低用力肺活量（FVC）的年下降率，显示可减缓特发性肺纤维化（IPF）的进展。然而，实际经验有限。
评估尼达尼布在一家三级转诊间质性肺疾病治疗中心的大量患者中的疗效和安全性。
回顾了确诊为 IPF 的患者的记录。从每次就诊中记录完整的病史、肺功能和不良事件（AE）。根据最近的出版物，疾病进展定义为 FVC 下降≥5%和/或一氧化碳弥散量下降≥15%。仅将治疗时间≥3 个月的患者纳入疗效评估。
共 64 例患者接受治疗。平均±标准偏差（SD）FVC 为 71±21%预计值，从诊断到开始尼达尼布治疗的平均时间为 23.8 个月。近一半的患者（n=30，47%）曾接受过吡非尼酮治疗。平均随访时间为 11 个月。在开始尼达尼布治疗后的 6 个月，67%的患者稳定。从基线到 3 个月时，预计 FVC 的平均±SD 变化为 0.2±7.8%，6 个月时为-1.3±7.9%，9 个月时为-2.1±9%。腹泻是 33%的患者最常见的 AE，通常可管理。
来自这一真实世界临床环境的结果支持了先前进行的临床试验的结果，并表明尼达尼布对 IPF 的治疗有效，与疾病稳定相关。尼达尼布通常具有良好的耐受性。
