非 IPF 進行性肺線維症に対するニンテダニブ: 実世界の多施設観察研究からの 12 か月の結果データ

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[HTML] Nintedanib for non-IPF progressive pulmonary fibrosis: 12-month outcome data from a real-world multicentre observational study

L Raman, I Stewart, SL Barratt, F Chua… - ERJ Open …, 2023 - Eur Respiratory Soc

… non-IPF PPF, we have demonstrated that nintedanib was safe, … Nintedanib did not appear
to have excess deleterious effects … treatment of non-IPF ILD where progression has occurred …

Nintedanib for non-IPF progressive pulmonary fibrosis: 12-month outcome data from a real-world multicentre observational study:
Abstract
Background: Nintedanib slows lung function decline for patients with non-idiopathic pulmonary fibrosis progressive pulmonary fibrosis (PPF) in clinical trials, but the real-world safety and efficacy are not known.

Methods: In this retrospective cohort study, standardised data were collected from patients in whom nintedanib was initiated for PPF between 2019 and 2020 through an early-access programme across eight centres in the United Kingdom. Rate of lung function change in the 12 months pre- and post-nintedanib initiation was the primary analysis. Symptoms, drug safety, tolerability and stratification by interstitial lung disease subtype and computed tomography pattern were secondary analyses.

Results: 126 patients were included; 67 (53%) females; mean±sd age 60±13 years. At initiation of nintedanib, mean forced vital capacity (FVC) was 1.87 L (58% predicted) and diffusing capacity of the lung for carbon monoxide (D LCO) was 32.7% predicted. 68% of patients were prescribed prednisolone (median dose 10 mg) and 69% were prescribed a steroid-sparing agent. In the 12 months after nintedanib initiation, lung function decline was significantly lower than in the preceding 12 months: FVC -88.8 mL versus -239.9 mL (p=0.004), and absolute decline in D LCO -2.1% versus -6.1% (p=0.004). Response to nintedanib was consistent in sensitivity and secondary analyses. 89 (71%) out of 126 patients reported side-effects, but 86 (80%) of the surviving 108 patients were still taking nintedanib at 12 months with patients reporting a reduced perception of symptom decline. There were no serious adverse events.

Conclusion: In PPF, the real-world efficacy of nintedanib replicated that of clinical trials, significantly attenuating lung function decline. Despite the severity of disease, nintedanib was safe and well tolerated in this real-world multicentre study.
非 IPF 進行性肺線維症に対するニンテダニブ: 実世界の多施設観察研究からの 12 か月の結果データ:
概要
- 背景: ニンテダニブはPPF患者の肺機能低下を遅らせるが、実際の安全性・有効性不明
- 方法: レトロスペクティブコホート研究、2019-2020年のPPF患者データ
- 主要分析: ニンテダニブ開始前後12か月の肺機能変化率
- 二次分析: 症状、薬物安全性、忍容性、間質性肺疾患サブタイプ・CTパターン
- 結果: 126人の患者、平均年齢60歳、肺機能低下有意に低い
- 副作用: 71%が報告、重大有害事象なし
- 結論: ニンテダニブはPPFの実世界で有効、安全、忍容性良好