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A Real-Life Multicenter National Study on Nintedanib in Severe Idiopathic Pulmonary Fibrosis

2018; Karger Publishers; Volume: 95; Issue: 6 Linguagem: Inglês

10.1159/000487711

1423-0356

Sergio Harari, Antonella Caminati, Venerino Poletti, Marco Confalonieri, Stefano Gasparini, Donato Lacedonia, Fabrizio Luppi, Alberto Pesci, Alfredo Sebastiani, Paolo Spagnolo, Carlo Vancheri, Elisabetta Balestro, Martina Bonifazi, Stefania Cerri, Federica De Giacomi, Roberto Porta, Maria Pia Foschino Barbaro, Annalisa Fui, Patrizio Pasquinelli, Roberta Rosso, Sara Tomassetti, Claudia Specchia, Paola Rottoli,

Sarcoidosis and Beryllium Toxicity Research

<b><i>Background:</i></b> Two therapeutic options are currently available for patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF): pirfenidone and nintedanib. To date, there is still insufficient data on the efficacy of these 2 agents in patients with more severe disease. <b><i>Objectives:</i></b> This national, multicenter, retrospective real-life study was intended to determine the impact of nintedanib on the treatment of patients with severe IPF. <b><i>Methods:</i></b> All patients included had severe IPF and had to have at least 6 months of follow-up before and at least 6 months of follow-up after starting nintedanib. The aim of the study was to compare the decline in lung function before and after treatment. Patient survival after 6 months of therapy with nintedanib was assessed. <b><i>Results:</i></b> Forty-one patients with a forced vital capacity (FVC) ≤50% and/or a diffusing capacity of the lung for carbon monoxide (D_LCO) ≤35% predicted at the start of nintedanib treatment were enrolled. At the 6-month follow-up, the decline of D_LCO (both absolute and % predicted) was significantly reduced compared to the pretreatment period (absolute D_LCO at the –6-month, T₀, and +6-month time points (5.48, 4.50, and 5.03 mmol/min/kPa, respectively, <i>p</i> = 0.03; D_LCO% predicted was 32.73, 26.54, and 29.23%, respectively, <i>p</i> = 0.04). No significant beneficial effect was observed in the other functional parameters analyzed. The 1-year survival in this population was 79%, calculated from month 6 of therapy with nintedanib. <b><i>Conclusions:</i></b> This nationwide multicenter experience in patients with severe IPF shows that nintedanib slows down the rate of decline of absolute and % predicted D_LCO but does not have significant impact on FVC or other lung parameters.