Data di Pubblicazione:
2022
Citazione:
Nintedanib in IPF: Post hoc Analysis of the Italian FIBRONET Observational Study / S. Harari, A. Pesci, C. Albera, V. Poletti, C. Amici, G. Crespi, B. Campolo, C. Vancheri. - In: RESPIRATION. - ISSN 0025-7931. - 101:6(2022), pp. 577-584. [10.1159/000521138]
Abstract:
Background: The FIBRONET study was an observational study of patients with idiopathic pulmonary fibrosis (IPF) in Italy. Objectives: In this post hoc descriptive analysis, we describe changes in lung function, anxiety/depression, coughing, exacerbations, and adverse events (AEs) in patients receiving nintedanib treatment. Methods: Patients with IPF from 20 centers in Italy, aged >= 40 years who received nintedanib for >= 7 months, were followed up for 12 months from study enrollment, attending clinic visits every 3 months. Outcomes included change in forced vital capacity (FVC)% predicted from baseline to 12 months, anxiety/depression measured by the Hospital Anxiety and Depression Scale (HADS), and the proportion of patients with cough, AEs, and exacerbations. Results: In total, 52 patients received nintedanib (mean duration of 11.6 months). Ten patients had dose reductions from 150 mg to 100 mg twice daily, due to AEs. FVC% predicted was unchanged in the overall nintedanib population (78.7% at baseline; 79.8% at 12 months) and those with a reduced dose (77.7% at baseline; 81.0% at 12 months). HADS score was low at baseline and throughout the study. The proportion of patients with cough decreased from 50.0% to 21.2% over 12 months. Two patients experienced exacerbations, 2 patients discontinued treatment, and 27 (51.9%) reported AEs. The most common AE was diarrhea (34.6%). Conclusions: In patients with IPF who received nintedanib in the FIBRONET study, FVC% predicted was stable over 12 months, and the proportion of patients with cough decreased. The safety profile was consistent with the known safety profile for nintedanib in IPF.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Antifibrotic treatment; Idiopathic pulmonary fibrosis; Lung function; Nintedanib; Observational study
Elenco autori:
S. Harari, A. Pesci, C. Albera, V. Poletti, C. Amici, G. Crespi, B. Campolo, C. Vancheri
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