Background Idiopathic pulmonary fibrosis (IPF) is a specific type of chronic fibrosing interstitial pneumonia. Nintedanib is a tyrosine kinase inhibitor which has been approved for the clinical treatment of IPF in adults.
Purpose To evaluate the efficacy and adverse effects of nintedanib in a tertiary care hospital.
Material and methods An observational retrospective study was conducted in patients receiving treatment with nintedanib from May 2015 to September 2016. Measured variables were: age, sex and smoking habits. Pulmonary function tests (PFT) such as forced expiratory volume (FEV), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) were analysed before and after the treatment was initiated, as was the presence of non-obstructive pattern (FEV1/CVF >0.7). As FVC is the most relevant mortality predictor factor in IPF, the rate of decline in FVC (>10%) was measured to asses efficacy. The presence of adverse reactions and alterations in hepatic enzymes were reviewed to asses safety.
Results 9 patients were receiving nintedanib 150 mg twice daily. 100% of patients were men with a mean age of 63 years. 83% had been smokers. All patients showed a non-obstructive respiratory pattern. 3 of 9 patients showed a decline in FVC >10%, 1 >5%, 3 remained stable and 2 an improvement in FVC (3–14%). 8 patients had deterioration in FEV with a mean of 2% compared with previously. DLCO also deteriorated in 7 patients, the mean compared with previously was 11%. All patients remained on a non-obstructive pattern during the study. 8 of 9 patients had adverse reactions. The most frequent was diarrhoea (38%) followed by vomiting (25%); others less frequent (≤ 12.5%) adverse effects were abdominal pain, pyrosis and hypotension. Only 1 patient suffered alterations in hepatic enzymes. 3 patients had to stop treatment due to adverse events.
Conclusion Nintedanib has shown benefit in decreasing (not stopping) progression of IPF; only 33% of patients had deterioration >10% in FVC. The adverse drug reaction rate was high (89%), and 3 of 9 patient had to stop treatment. Studies with a broader population of patients should be carried out to assess whether the balance between efficacy and safety is appropriate.
References and/or acknowledgements INFORME DE POSICIONAMIENTO TERAPÉUTICO PT-NINDETANIB-FIBR_PULM/V1/18122015
No conflict of interest
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