The predicted lung function of patients with idiopathic pulmonary fibrosis (IPF) treated with nintedanib as part of the FIBRONET study was stable over 1 year, according to results of a post hoc analysis published in Respiration. The proportion of patients with coughs also decreased, and the safety profile of the treatment was consistent with its known safety profile in IPF.
These results add “to the body of evidence showing the effectiveness of nintedanib in the real world,” the authors said. “Overall, our results show a high proportion of patients with stable disease over the 12 months of observation (ie, no disease progression), a safety profile consistent with what is already known about the tolerability of nintedanib, and a low rate of discontinuation.”
FIBRONET was a real-world, observational study conducted on 209 participants with IPF to evaluate the characteristics, management, and clinical course of patients treated in Italian pulmonary centers.
Here, researchers described the changes in lung function, anxiety and depression, coughing, exacerbations, and adverse events in patients receiving nintedanib. Nintedanib is a kinase inhibitor used to treat IPF and other interstitial lung diseases. It is 1 of 2 drugs currently approved for IPF.
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In 52 patients who received the treatment for an average of 11.6 months, the percent predicted forced vital capacity remained the same, even when the dose was reduced. The patients’ Hospital Anxiety and Depression Scale scores were low at baseline and throughout the study.
The proportion of patients with a cough decreased from 50% to 21.2% over the year. Two patients had exacerbations, 2 patients stopped treatment, and 27 had adverse events, the most common of which was diarrhea.
“These findings are consistent with the efficacy and safety of nintedanib that has been demonstrated in controlled clinical trials,” the researchers concluded.
Harari S, Pesci A, Albera C, et al. Nintedanib in IPF: post hoc analysis of the Italian FIBRONET observational study. Respiration. Published online January 25, 2022. doi:10.1159/000521138
IPF Italian observational study (FIBRONET) in idiopathic pulmonary fibrosis. ClinicalTrials.gov. June 17, 2016. Updated September 13, 2019. Accessed February 7, 2022.