Antifibrotic treatment adherence, efficacy and outcomes for patients with idiopathic pulmonary fibrosis in Spain: a real-world evidence study

IF 3.6 3区医学 Q1 RESPIRATORY SYSTEM

BMJ Open Respiratory Research Pub Date : 2024-04-01 DOI:10.1136/bmjresp-2023-001687

A. R. Romero Ortiz, B. Jiménez-Rodríguez, Cecilia López-Ramírez, Ángela López-Bauzá, María Pérez-Morales, José Antonio Delgado-Torralbo, Cristina Villalba Moral, B. Alcázar-Navarrete

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引用次数: 0

Abstract

Background Idiopathic pulmonary fibrosis (IPF) is a rare disorder associated with increased mortality and morbidity. There are currently two drugs approved for IPF but their safety and efficacy profile in real-world settings in Spain is not well understood. Methods An observational, multicentre, prospective study was carried out among patients with IPF who started treatment with pirfenidone or nintedanib from 2015 to 2021. Data regarding clinical characteristics, drug adherence, safety profiles and clinical outcomes between these two drugs were collected. Results 232 patients were included in the analysis. There were no meaningful differences between both groups at baseline. Patients who started pirfenidone showed a decreased risk for treatment withdrawal compared with those starting nintedanib (HR 0.65 (95% CI 0.46 to 0.94; p=0.002)). Time to first adverse event and all-cause mortality was similar between study groups. Risk factors for withdrawal were female sex, diarrhoea and photosensitivity. Conclusions in this real-world study, both pirfenidone and nintedanib showed similar efficacy profiles. Pirfenidone was associated with less treatment discontinuations due to side effects.

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西班牙特发性肺纤维化患者的抗纤维化治疗依从性、疗效和结果：真实世界证据研究

背景特发性肺纤维化（IPF）是一种罕见的疾病，死亡率和发病率均有上升。目前有两种药物获准用于治疗 IPF，但在西班牙，人们对这两种药物在实际环境中的安全性和疗效还不甚了解。方法对 2015 年至 2021 年期间开始接受吡非尼酮或宁替尼治疗的 IPF 患者进行了一项多中心前瞻性观察研究。研究收集了这两种药物的临床特征、用药依从性、安全性和临床疗效等方面的数据。结果 232 名患者被纳入分析。两组患者在基线上没有明显差异。与开始服用宁替达尼的患者相比，开始服用吡非尼酮的患者退出治疗的风险降低（HR 0.65 (95% CI 0.46 to 0.94; p=0.002)）。各研究组发生首次不良事件和全因死亡率的时间相似。女性、腹泻和光敏感是停药的风险因素。结论在这项真实世界研究中，吡非尼酮和宁替尼显示出相似的疗效。吡非尼酮因副作用而中断治疗的情况较少。

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来源期刊

BMJ Open Respiratory Research RESPIRATORY SYSTEM-

CiteScore

6.60

自引率

2.40%

发文量

审稿时长

12 weeks

期刊介绍： BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.