Antifibrotic agents may reduce mortality risk in IPF
Among patients with idiopathic pulmonary fibrosis, the antifibrotic medications pirfenidone and nintedanib were associated with significantly reduced risks for all-cause mortality and hospitalizations vs. those who received no treatment, according to data published in the American Journal of Respiratory and Critical Care Medicine.
Pirfenidone (Esbriet, Genentech) and nintedanib (Ofev, Boehringer Ingelheim) received FDA approval to treat IPF in 2014 based on clinical trials showing that they slowed decline in lung function and may improve survival.
“Despite the initial excitement surrounding the approval of the antifibrotics, several questions remained, including whether these medications actually work in general clinical practice to improve survival and decrease hospitalizations. To date, there has been no analysis of the available real-world data for patients with IPF on therapy to answer these clinically important questions,” the researchers wrote.
Therefore, the researchers conducted a retrospective cohort analysis using a U.S. insurance database to fill these gaps in knowledge. Of 8,098 patients with IPF, they identified 1,255 who filled prescriptions for pirfenidone or nintedanib from 2014 to 2018 (mean age, 72.2 years; 37.1% women) and propensity score-matched them with 1,255 who were not treated (mean age, 72.4 years; 36.9% women). Mean follow-up was 9.93 months.
Results linked treatment with pirfenidone or nintedanib to a significant reduction in risk for all-cause mortality (HR = 0.77; 95% CI, 0.62-0.98). However, this mortality benefit was only seen through the first 2 years of follow-up. This finding is “intriguing,” the researchers noted, but the reasons remain unclear.
“These medications are not curative, meaning that fibrosis continues to progress over time, as do clinical events such as acute exacerbations,” they wrote.
The researchers also found a decrease in the risk for acute hospitalizations in the treated group compared with the untreated group (HR = 0.7; 95% CI, 0.61-0.8), with respiratory failure as the most common reason for hospitalization.
Additionally, a subgroup analysis also showed that all-cause mortality did not differ significantly between patients treated with pirfenidone vs. nintedanib (HR = 1.14; 95% CI, 0.79-1.65).
Although this study presented a real-world picture of the effects of antifibrotic medications on mortality and acute hospitalizations in patients with IPF, the study was limited by its inclusion of patients with private insurance and those with Medicare Advantage plans only. Other limitations included potential confounders, the fact that filling prescriptions does not ensure patient adherence and the use of the Social Security Death Master file to determine mortality.
“Further research is needed to test the hypothesis that these treatments reduce early, but not long-term, mortality as demonstrated in our study,” the researchers wrote. – by Melissa Foster
Disclosures: The authors report no relevant financial disclosures.