Abstract
Introduction: Nintedanib, is an intracellular inhibitor that targets multiple tyrosine kinases, exerts its effect through the regulation of the PDGF, VEGF and FGF and has been recently approved for the treatment of IPF.
Objective: To describe our clinical experience of IPF patients treated with Nintedanib in our center within a NPU program from 11/2014 to 1/2016.
Methods: The diagnosis of IPF was assessed according to the 2011 ATS/ERS/JRS/ALAT guidelines. 80 IPF patients (58male), mean age of 72.4 years (range:50-90years), 97.2% ex-smokers,of all stages [14% severe IPF(FVC<50% and/or DLco<35%)] were included. Comorbidities included arterial hypertension (n=15, 18.75%), cardiac failure (n=11, 13.7%), diabetes mellitus (n=10, 12.5%).24 patients (30%) had previously received other pharmacological treatments [pirfenidone(n=16, 20%), NAC/azathioprine/cortisone (n=8, 10%)]. Adverse drug reactions (ADR), discontinuation, clinical, radiological and pulmonary function tests data were collected.
Results: 58 patients (72.5%) with a mean exposure of 5.12 months experienced ADR. The most important ADRs were diarrhea (n=37, 46.2%) [mild (n=16, 20%), moderate (n=14, 17.5%), severe (n=7, 8.7%)], nausea (n=16, 20%), anorexia (n=12, 15%), vomiting (n=10, 12.5%) and weight loss (n=12, 15%), 23 patients (28.7%) stopped the treatment (9 due to death and disease progression, 14 due to ADRs and intolerance of low dosage). Importantly 11 patients (13.7%) reported cough improvement. Mean relative decline of %FVC and DLCO decline for 23 patients was -7.8% and -5.2% respectively for a 6 months treatment period.
Conclusion: Nintedanib is a tolerable and safe treatment for IPF. The most common ADR is diarrhea.
- Copyright ©the authors 2016