Results from a Phase 3b lung imaging study being presented at the Pulmonary Fibrosis Foundation (PFF) Summit in Nashville this week show that Ofev (nintedanib) is effective in slowing the fibrotic process when compared to placebo in patients with idiopathic pulmonary fibrosis (IPF).
Ofev was approved for the treatment of IPF in 2014, and is the only currently-approved kinase inhibitor to treat the condition. A second drug, the antifibrotic and anti-inflammatory agent Esbriet (pirfenidone), was also approved on that same day.
The origin of IPF is unknown, however, the disease can be life-threatening if not treated quickly. It is often characterized by shortness of breath, fatigue, dry, hacking cough, and shallow breathing, and until the approvals of Ofev and Esbriet, treatment was limited to oxygen therapy, pulmonary rehabilitation, and/or lung transplant.
The primary endpoint of the trial being presented at the PPF Summit was a change in relative Quantitative Lung Fibrosis (QLF) score from baseline to 6 months of treatment, and the secondary endpoint was absolute mean change in forced vital capacity (FVC). Results from the study showed a clear reduction in the development of lung fibrosis among people treated with Ofev.
The change in QLF score from baseline to 6 months was 11.4% in people treated with Ofev versus 14.6% in the placebo group. The adjusted mean absolute changes in FVC from baseline to the sixth month of treatment were −14.2 mL in the Ofev group and −83.2 mL in the placebo group (difference 69.0 mL).
"This study reaffirms the beneficial effect of Ofev for reducing lung function decline and slowing disease progression, and is the first to suggest that there may be a differential effect of Ofev treatment versus placebo in lung fibrosis change," said Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim in a press release
. "We look forward to presenting additional findings from this study at major medical congresses next year and confirmation of these results in future studies."
IPF, if not treated properly, can cause permanent scarring in the lungs. In the United States, it affects approximately 132,000 people, most commonly men over the age of 65 years.
"With the aid of high resolution CT scans, we have observed a reduction in the progression of lung fibrosis with Ofev versus placebo," said lead study investigator Lisa Lancaster, M.D., clinical director of the Interstitial Lung Disease Program at Vanderbilt University Medical Center. "These encouraging results demonstrate that through an imaging scan we identified differential responses in fibrotic changes between groups that will help doctors make informed treatment decisions."
Common side effects in patients with IPF given Ofev have included liver problems, diarrhea, nausea, vomiting, heart attack, stroke, and bleeding. More data needs to be compiled before it can be determined that the drug is or is not safe and effective in children.
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