Initial clinical experience with nintedanib for treatment of idiopathic pulmonary fibrosis (IPF): About 20 cases

Introduction: Nintedanib is a potent inhibitor of intracellular receptors tirosinkinasas exerts its effect on the PDGF, VEGF and FGF. Nintedanib was recently approved by the EMA on January 15, 2015, for the treatment of IPF. We present the initial experience of 20 patients treated with nintedanib. Aims and Objectives: To describe the initial experience of 20 patients with IPF treated with Nintedanib in different hospitals in Spain. Methods: The diagnosis of IPF was established according to the criteria of the guidelines of 2011.Clinical, radiological, pulmonary function test(PFT) data were collected .Side effects related to nintedanib treatment, interruption and/or discontinuation. Results: 20 patients were included. Most were male. At diagnosis HRCT shows UIP patternt in 60%of patients. For the diagnosis of IPF 35% underwent a surgical lung biopsy. Treatments were started between august 2011 and december 2014, 7 patients(35%) had participate in INPULSIS trials. The started dose was 150 mg every 12 hours. Only 1 patient discontinued treatment due to side effects, there were dose reduction to 100 mg every 12 hours in 7 patients. Regarding side effects 9 patients had diarrhea, 2 had nausea and 8 showed weight loss. None had elevated transaminases No acute exacerbations were recorded. One patient died. Conclusion: Nintedanib is a new antifibrotic agent recently approved by the EMA and pending marketing in Spain, for the treatment of IPF The side effect profile in these 20 patients appears consistent with the data published so far in the clinical trial of the drug More patients and further monitoring is required to establish the efficacy and safety in clinical practice.