Benefits of nintedanib extend to patients with advanced IPF
medwireNews: Results of a real-world study suggest that nintedanib delays lung function decline in patients with idiopathic pulmonary fibrosis (IPF) irrespective of disease severity.
“Recent randomised controlled trials of patients with mild-to-moderate IPF revealed that nintedanib reduced the rate of decline of forced vital capacity (FVC) and disease progression, and that adverse events (AEs) were well tolerated”, but data in patients with advanced IPF are limited, say the study authors.
Jin Woo Song and colleagues from the Asan Medical Centre in Seoul, South Korea, analysed data from 108 patients with IPF who received treatment with the tyrosine kinase inhibitor at their institution between 2014 and 2016. Of these patients, 47.2% had advanced disease, defined as FVC of less than 50% of predicted or diffusing capacity of less than 30% of predicted.
As reported in Respiratory Research, nintedanib-treated patients experienced a significant overall reduction in the average predicted monthly rate of FVC decline, from 0.55% at baseline to 0.32% after a median 44.1 weeks of treatment.
When patients were categorized based on IPF severity, those with advanced disease also experienced a significant reduction in the average predicted monthly rate of FVC decline over the study period, from 0.77% to 0.22%, whereas those with non-advanced IPF experienced a nonsignificant decrease, from 0.41% to 0.33%.
Similarly, rates of disease progression – defined as at least a 10% absolute decline in FVC over 12 months – were significantly lower after nintedanib treatment compared with baseline in the overall study population (33.3 vs 61.1%) and in those with advanced IPF (9.1 vs 78.9%), and were numerically lower in patients with non-advanced IPF (41.2 vs 51.4%).
The majority (97.2%) of patients experienced adverse events (AEs) over the course of the study, most commonly diarrhoea (50.0%), followed by anorexia (45.4%) and nausea/vomiting (24.1%). The overall incidence of AEs was comparable among patients with advanced compared with non-advanced disease (98.0 vs 95.5%), but a significantly higher proportion of patients in the advanced disease group discontinued treatment as a result of AEs (68.0 vs 40.0%).
Noting that the most frequent reason for treatment discontinuation was disease progression, the researchers say that the higher rate of discontinuation in the advanced IPF group “may be due to the advanced status itself.”
Song and team conclude that nintedanib could “represent a treatment option for patients with advanced IPF, especially those who are not candidates for lung transplantation”, but larger studies are needed to confirm the findings.
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