When 2 new treatments for idiopathic pulmonary fibrosis (IPF) were approved by FDA last year, there was not much data available on the drugs in patient populations.
However, that is all changing. In late October, Boehringer Ingelheim presented the findings from phase 3 clinical trials on Ofev (nintedanib) at the American College of Chest Physicians Annual Meeting (CHEST 2015) in Montreal, Canada. Interim results from another INPULSIS clinical trial on Ofev were presented at the European Respiratory Society (ERS) International Congress 2015.
Here are the top 3 findings from the Ofev trials:
The first analysis of the phase 3 trials showed treatment with Ofev has similar and consistent effects on disease progression (as measured by annual rate of forced vital capacity [FVC] decline) and the amount of time to the first acute exacerbation—regardless of whether people with IPF enrolled in the trials in the United States or internationally.
“In a rare lung disease like IPF, which has unique characteristics and affects people around the world, it is critical to help pulmonologists make informed treatment decisions by understanding the effectiveness of OFEV in these different patient populations,” said John Huggins, MD, associate professor with the Department of Medicine, Medical University of South Carolina. “This new analysis showed that Ofev is comparably effective in people with IPF regardless of where they were enrolled in the trial.”
Researchers found that the annual rate of decline in FVC in US patients was −94.7 mL/year with Ofev and −242.5 mL/year with placebo, while in non-US patients it was −117.0 mL/year with Ofev and −220.0 mL/year with placebo. The hazard ratio for time to first acute exacerbation was 0.37 in US patients and 0.68 in non-US patients, both in favor of Ofev.
The second analysis presented at CHEST 2015 showed comparable efficacy with Ofev treatment on slowing disease progression, regardless of the presence of extensive lung scarring (or honeycombing) on imaging tests at diagnosis.
In total, 567 patients (Ofev 326, placebo 241) had honeycombing at baseline and 494 (Ofev 312, placebo 182) did not. In patients with honeycombing, the adjusted annual rate of decline in FVC was −117.8 mL/year with Ofev and −212.8 mL/year with placebo.
An interim analysis of the INPULSIS-ON open-label extension trial of Ofev showed no relevant changes in the safety and tolerability of Ofev. The results also suggest that treatment has a long-term effect (approximately 2 years) on slowing disease progression across both pivotal and open-label trials (as measured by annual rate of forced vital capacity [FVC] decline). The interim analysis showed that the decline in FVC at 48 weeks in patients continuing treatment with OFEV in the extension trial was comparable to what was observed in the 52-week INPULSIS trials.
“These data are significant because they provide additional evidence that Ofev maintains its safety profile and efficacy at slowing IPF disease progression over approximately two years, reinforcing the previously-reported 1-year phase 3 data,” said Eric White, MD, associate professor of medicine, pulmonary and critical care with the University of Michigan Health System. “Studies like INPULSIS-ON are important because they inform us about the longer-term safety and efficacy of Ofev. IPF is a chronic disease that oftentimes requires long-term treatment. Evidence that Ofev maintains its clinical effect in the absence of any new safety signals provides me with more information to discuss with my patients considering treatment with Ofev.”