Ofev prolongs IPF patient survival in real-world Czech registry study
However, drug did not show significant slowing of disease progression
When used in a real-world setting, Ofev (nintedanib) significantly prolonged the survival of idiopathic pulmonary fibrosis (IPF) patients, according to an analysis of Czech registry data.
Yet, Ofev was not associated with a significant slowing of lung function decline or with other estimations of disease progression.
Findings were reported in the study “The effect of nintedanib on lung functions and survival in idiopathic pulmonary fibrosis: real-life analysis of the Czech EMPIRE registry,” which was recently published in the journal BMC Pulmonary Medicine.
Ofev is an antifibrotic therapy approved for IPF in many countries worldwide. It works by inhibiting tyrosine kinases, a family of enzymes involved in signaling pathways that drive the buildup of scar tissue (fibrosis) in the lungs of IPF patients.
Clinical trial data have indicated the therapy can significantly slow disease progression by preventing lung function decline. The oral therapy has been available to patients in the Czech Republic since 2016.
Real-world efficacy of Ofev among patients was examined
In this study, scientists investigated the real-world efficacy of Ofev among patients included in the Czech arm of the European MultiPartner IPF Registry (EMPIRE), which includes long-term clinical data from IPF patients gathered across 11 Central European countries.
The analysis involved 611 patients, 72% of whom were men, with a mean age of 71 years. Of them, 430 (70%) were treated with Ofev and 181 (30%) were not treated with an antifibrotic medication.
Over the course of a median follow-up of 17 months, patients were monitored for survival, lung function, and other measures of disease severity.
Results showed patients treated with Ofev had a significantly longer median estimated survival time compared with those who were not on any antifibrotic treatment.
Specifically, the median survival in the untreated group was 47 months, or nearly four years, whereas the median survival in the Ofev group couldn’t be calculated with five years of follow-up since most patients were still alive.
While 37% of untreated patients were still alive after five years, 65% of those on Ofev were alive. Overall, the risk of death was reduced by 55% with Ofev treatment.
When Ofev-treated patients were stratified by GAP scores, a way of predicting mortality based on a person’s sex, age, and lung function, those in the GAP 3 category were at the highest risk of having a poor prognosis. A higher number in GAP category indicates a worse outcome for IPF patients, and thus, the finding is consistent with the function of the predictive model, the authors noted.
Ofev was not associated with a slowing of lung function decline during follow-up, with no significant differences observed between those on the therapy and those not on it.
Moreover, no differences were observed in the Ofev group when patients were stratified by GAP category. That finding is in contrast to results from pivotal clinical trials of Ofev, which found the therapy to significantly slow lung function decline relative to a placebo.
Changes in the composite physiological index, a way of predicting IPF patients’ disease progression using lung function and lung imaging tests, did not differ over the course of follow-up between the two groups.
“In the IPF real-world registry EMPIRE … the overall survival of the patients treated by [Ofev] is longer than of those with no antifibrotic treatment,” despite the lack of impact on lung function, the team concluded.
A previous analysis of data from the Czech arm of EMPIRE found that Esbriet (pirfenidone) — the other approved antifibrotic medication for IPF — significantly slowed lung function decline and prolonged patient survival.
About the Author
