Ofev (nintedanib) is effective at slowing idiopathic pulmonary fibrosis (IPF) progression in patients over time regardless of their degree of lung function at the beginning of treatment, according to new results from an extension of a Phase 3 clinical trial.
Ofev, by Boehringer Ingelheim, was approved by the U.S. Food and Drug Administration (FDA) in 2014 to treat IPF based on efficacy shown in slowing disease progression and lung scarring in a number of clinical studies. These included two global Phase 3 studies, INPULSIS 1 and 2 (NCT01335464 and NCT01335477), which assessed the oral treatment’s efficacy and safety — at 150 mg twice daily compared to placebo — over a 52-week period.
More than 730 patients who completed the earlier trials opted to continue with the treatment in an open-label extension study, called INPULSIS-ON (NCT01619085), assessing the safety and tolerability effects of this kinase inhibitor over up to six years (312 weeks).
Results from the interim analysis, conducted at 96 weeks and presented at the recent 2017 CHEST annual meeting, found that IPF patients being treated with Ofev showed a consistent slowing in their annual rate of decline in lung function, regardless of their lung capacity at baseline.
Researchers measured lung function at baseline and its changes during the first 96 weeks of the extension study using forced vital capacity (FVC), or the amount of air that can be forcibly exhaled after a breath.
Tesults showed that there was a consistent slowing in the annual rate decline of lung function in all patients, despite variations in disease severity at the study’s start or baseline.
Moreover, after analyzing all patients in INPULSIS-ON and comparing their annual rates of decline at 96 weeks to those recorded in the earlier INPULSIS trials at 52 weeks, researchers observed that these rates were maintained: -117.8 ml/year versus -113.6 ml/year, respectively.
“Baseline lung function and changes in FVC over time are both important predictors of long-term outcomes in IPF, so it is critical to maintain lung function across disease severities,” said Mitchell Kaye, president of Minnesota Lung Center/Minnesota Sleep Institute, Minneapolis, in a press release.
“These new results provide further supportive evidence for the long-term efficacy of Ofev, suggesting the value of initiating IPF treatment irrespective of a person’s disease severity at diagnosis,” Kaye added.
Results from a second study, also presented at the CHEST meeting, highlighted similarities between patients in a”real-world” settings and those enrolled in the Phase 3 INPULSIS and ASCEND (NCT01366209) clinical trials. The results analysed data from the IPF prospective outcomes registry (IPG-PRO; NCT01915511), which collects data on strategies used in the diagnosis, management and treatment of patients with IPF.