Ofev, Esbriet Found to Significantly Reduce Risk of Death in IPF
Treatment with either Ofev (nintedanib) or Esbriet (pirfenidone) — both antifibrotic therapies, but with different mechanisms of action — “offers protection” and can slow lung function decline in people with pulmonary fibrosis (PF), according to a new analysis.
Moreover, the results showed that these medications can significantly reduce the risk of death in idiopathic pulmonary fibrosis (IPF), the most common form of pulmonary fibrosis, the researchers said.
The scientists wrote that “similar efficacy [was] shown between the two anti-fibrotic agents currently in clinical use.”
Further research is needed to clarify the effect of these medicines on mortality risk in non-IPF types of pulmonary fibrosis, the team said.
The study, “Efficacy of antifibrotic drugs, nintedanib and pirfenidone, in treatment of progressive pulmonary fibrosis in both idiopathic pulmonary fibrosis (IPF) and non-IPF: a systematic review and meta-analysis,” was published in the journal BMC Pulmonary Medicine.
Ofev and Esbriet are both oral medications that are widely approved to treat certain types of pulmonary fibrosis. Ofev is marketed by Boehringer Ingelheim while Esbriet is sold by Genentech; neither company was involved in the present study, which was conducted by researchers from the Countess of Chester Hospital NHS Trust, and their colleagues.
The U.K. team performed a meta-analysis to analyze the effects of these antifibrotic medications on forced vital capacity (FVC) — a common lung function parameter that measures how much air a person can forcefully exhale after a deep breath — and mortality risk. A meta-analysis is a type of review in which researchers collect and pool data from multiple studies.
In total, the team’s analysis included 11 studies covering 13 clinical trials that tested either Ofev or Esbriet. Most of the trials enrolled patients with IPF, while a few included people with non-IPF forms of pulmonary fibrosis, such as interstitial lung disease associated with systemic scleroderma.
“We believe that this meta-analysis is the first to attempt to pool data from [randomized controlled clinical trials] on both commonly used anti-fibrotic drugs in both IPF and non-IPF,” the researchers wrote.
The meta-analysis for FVC included 2,872 patients with IPF, as well as 1,292 non-IPF patients. Results showed that treatment with antifibrotic medications significantly slowed FVC decline, with an effect size of -0.306.
Additional analyses showed significant effects on FVC in both IPF and non-IPF patients, with no notable differences between the groups.
Analyses comparing Ofev against Esbriet, in terms of effect on FVC, found no significant difference between the two medications.
“Anti-fibrotic therapy offers protection against the rate of decline [in FVC], similar between the two anti-fibrotic agents currently in clinical use, with no obvious difference in efficacy whether the underlying condition was IPF or non-IPF with progressive fibrosis,” the researchers wrote.
Data on all-cause mortality were available for all but two of the 11 studies. Results of the mortality meta-analysis indicated that treatment with either Ofev or Esbriet reduced the risk of death by roughly 30%.
Sub-analyses found that antifibrotic treatment significantly reduced mortality risk for people with idiopathic PF, but that the effect in non-IPF patients was not statistically significant.
The team wrote that data on mortality in non-IPF “are insufficient to allow any firm conclusions,” but they noted that “changes in lung function provide the best predictor for mortality in these conditions.”
“Larger controlled studies in non-IPF are required to be confident about any general effect on mortality by anti-fibrotic therapy,” the scientists concluded.