Efficacy and Safety of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis: An Update
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REVIEW ARTICLE
Efficacy and Safety of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis: An Update Jose´ Antonio Rodrı´guez-Portal1,2
Ó The Author(s) 2017. This article is an open access publication
Abstract Idiopathic pulmonary fibrosis is a fatal form of progressive fibrosing interstitial pneumonia with limited treatment options. In recent years, its management has been transformed with the approval of two new antifibrotic drugs: nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that efficiently slows idiopathic pulmonary fibrosis progression and has an acceptable tolerability profile. This article reviews new available evidence on the long-term efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis. Data from extension trials indicate that nintedanib continues to slow disease progression for up to 3 years and is similarly effective in patients with mild and severe impairment of lung function. Treatment with nintedanib reduces the risk of acute exacerbations, and a combined analysis of data from clinical trials of nintedanib shows a trend towards a reduction in mortality. Nintedanib is well tolerated and has been shown to be safe for up to 51 months. Gastrointestinal events, mainly diarrhoea, are the main adverse events caused by the treatment. Currently available data confirm its safety profile in real-life clinical settings, with no new safety concerns identified in patients with comorbidities.
Key Points Idiopathic pulmonary fibrosis is a progressive form of fibrosing interstitial pneumonia with a fatal prognosis and a significant impact on the quality of life of affected patients. Nintedanib was shown to be effective in reducing the decline in lung function of patients with idiopathic pulmonary fibrosis and was approved for treatment of idiopathic pulmonary fibrosis less than 3 years ago. New studies indicate that nintedanib effectively slows disease progression up to 3 years, and is efficacious in mild, moderate and severe stages of the disease. Nintedanib is well tolerated and safe up to 3 years, with diarrhoea being the most common adverse event.
1 Introduction
& Jose´ Antonio Rodrı´guez-Portal [email protected] 1
Centro de Investigacio´n Biome´dica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain
2
Servicio de Neumologı´a, Hospital Universitario Virgen del Rocı´o, Av. Manuel Siurot, s/n, 41013 Seville, Spain
Idiopathic pulmonary fibrosis (IPF) is a fatal form of progressive fibrosing interstitial pneumonia. Advances in the understanding of its pathogenesis together with positive results from multiple clinical trials have transformed the management of IPF in the last decade. In recent years, two antifibrotic drugs have proved to be effective in slowing IPF progression: pirfenidone and nintedanib. Nintedanib
J. A. Rodrı´guez-Portal
was approved by the US Food and Drug Administration in October 2014 and by the European Medicines Agency in January 2015.
and FVC over time are used as a measure of disease progression and have p
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