Antoniou Katerina, Markopoulou Katerina, Tzouvelekis Argyrios, Trachalaki Athina, Vasarmidi Eirini, Organtzis Jiannis, Tzilas Vasilios, Bouros Evangelos, Kounti Georgia, Rampiadou Christina, Kotoulas Serafeim-Chrysovalantis, Bardaka Fotini, Bibaki Eleni, Fouka Evangelia, Meletis Georgios, Tryfon Stavros, Daniil Zoe, Papakosta Despina, Bouros Demosthenes
Dept of Thoracic Medicine, Faculty of Medicine, University of Crete, Heraklion, Greece.
These authors contributed equally.
ERJ Open Res. 2020 Jan 27;6(1). doi: 10.1183/23120541.00172-2019. eCollection 2020 Jan.
Nintedanib is a tyrosine kinase inhibitor approved for the treatment of idiopathic pulmonary fibrosis (IPF). In a retrospective, real-world study across seven Greek hospitals, we evaluated the effectiveness and safety of nintedanib in routine clinical practice. Patients diagnosed with IPF, as per guideline criteria or multidisciplinary diagnosis, received nintedanib between January 2013 and January 2018. We evaluated 244 patients: mean±sd age 71.8±7.5 years, 79.1% male, 45.1% current smokers and 33.1% ex-smokers at treatment initiation. At baseline, predicted forced vital capacity (FVC) was 73.3±20.7% and predicted diffusing capacity of the lungs for carbon monoxide ( ) was 42.6±16.7%. On average, patients spent 23.6±15.0 months on nintedanib. At 3 years, 78 patients had died, equating to a 3-year survival rate of 59.4% (unaffected by treatment discontinuation or dose reduction). FVC% pred and % pred were largely stable at 3 years, with no significant difference from baseline (FVC 73.3±20.7% pred 78±20.1% pred, p=0.074; 42.6±16.7% pred 40.4±18.1% pred, p=0.334). Of the 244 patients, 55.7% reported an adverse event. Gastrointestinal events were the most common (173 (77.2%) out of 224 total events) and 45.0% of patients experienced diarrhoea. Only 32 (13.1%) patients had to permanently discontinue nintedanib due to an adverse event. This real-world study shows a 3-year survival rate of 59.4% and a low discontinuation rate due to adverse events. Our experience is consistent with previous findings in clinical trials of nintedanib in IPF.
尼达尼布是一种被批准用于治疗特发性肺纤维化（IPF）的酪氨酸激酶抑制剂。在一项针对希腊七家医院的回顾性真实世界研究中，我们评估了尼达尼布在常规临床实践中的有效性和安全性。根据指南标准或多学科诊断被诊断为IPF的患者，在2013年1月至2018年1月期间接受了尼达尼布治疗。我们评估了244例患者：治疗开始时的平均年龄±标准差为71.8±7.5岁，男性占79.1%，当前吸烟者占45.1%，既往吸烟者占33.1%。基线时，预计用力肺活量（FVC）为73.3±20.7%，预计肺一氧化碳弥散量（ ）为42.6±16.7%。患者平均服用尼达尼布23.6±15.0个月。3年后，78例患者死亡，3年生存率为59.4%（不受治疗中断或剂量减少影响）。3年时FVC%预计值和 %预计值基本稳定，与基线无显著差异（FVC 73.3±20.7%预计值 78±20.1%预计值，p = 0.074； 42.6±16.7%预计值 40.4±18.1%预计值，p = 0.334）。在244例患者中，55.7%报告了不良事件。胃肠道事件最为常见（224例总事件中有173例（77.2%）），45.0%的患者出现腹泻。只有32例（13.1%）患者因不良事件不得不永久停用尼达尼布。这项真实世界研究显示3年生存率为59.4%，因不良事件导致的停药率较低。我们的经验与尼达尼布治疗IPF的既往临床试验结果一致。
