Nintedanib in Idiopathic Pulmonary Fibrosis: a single-centre real-life experience

Nintedanib is a tyrosine kinase inhibitor with anti-fibrotic and anti-inflammatory activity recently approved for the treatment of idiopathic pulmonary fibrosis (IPF). The object of the present study was to describe the characteristics and the outcome of a population of patients with IPF treated with Nintedanib at the Regional Referral Centre for Sarcoidosis and other Interstitial Lung Diseases of Siena from January 2015 to January 2016. 50 patients with IPF (38 male, age 73 ± 8.4) were enrolled. Pulmonary function tests were performed at baseline and follow-up (every 3 months). Nintedanib-related side effects were recorded in our database at every visit. Basal PFT showed FVC 65.5 ± 18.7 pred., FEV1 68.3 ±17.9, DLCO 38.8 ± 12.8 pred. At 6 months follow-up (21 patients) lung function was stable. At 12 months follow-up (12 patients) the decrement of FVC and FEV1 was respectively 5.8%± 12 and 10%±10. Survival analysis at 6 and 12 months showed mortality rates of 4% and 12%, respectively. At 3 months 16/46 (34.7%) patients experienced side effects: 10 had diarrhea (8 mild, 2 moderate), an increase of transaminases was detected in 6 pts. At 6 months, 5/37 (13%) pts showed diarrhea in 3 cases (2 persistent) and transaminases increase in 2 pts (1 persistent). At 12 months, 2/28 patients had persistent mild diarrhea. All side effects resolved with a brief suspension of the drug. Only 2 pts discontinued Nintedanib. Our real-life experience confirmed that in IPF patients adherence to therapy with Nintedanib and its safety profile are good. Side effects were generally mild not requiring dosage decrease over time. Discontinuation was a rare event.