Ofev Study Results Released of Fibrotic Progression in Patients with IPF

Boehringer Ingelheim announced results from a descriptive Phase IIIb lung imaging study providing evidence for the first time that Ofev (nintedanib) slowed the fibrotic process versus placebo in people with idiopathic pulmonary fibrosis (IPF).

The study showed a reduction in the development of lung fibrosis among people treated with Ofev, as measured by quantitative lung fibrosis score (QLF), which uses high resolution CT (HRCT) imaging to measure the extent of lung fibrosis (thickening and scarring of the lungs). Lower QLF scores indicate less fibrotic progression in the lung. In this study, the QLF score from baseline to 6 months was 11.4% in people treated with Ofev versus 14.6% in the placebo group (difference 3.2%, exploratory endpoint not statistically significant).

"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."

The primary endpoint of this randomized, double-blind, placebo-controlled, descriptive trial was change in relative QLF score from baseline to 6 months of treatment.

A secondary endpoint of the trial was absolute mean change in forced vital capacity (FVC), a measure of lung function. At baseline, mean FVC was 2997 (831) mL among people treated with Ofev and 2921 (834) mL among people on placebo. The adjusted mean absolute changes in FVC from baseline to month 6 were −14.2 mL and −83.2 mL in the Ofev and placebo groups, respectively (difference 69.0 mL).

IPF is a rare and serious lung disease that causes permanent scarring of the lungs. It affects as many as 132,000 Americans, typically men over the age of 65. Early diagnosis and proper care are critical to helping people treat their condition.

The FDA approved Ofev for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. Ofev is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.

The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW trial and the Phase III INPULSIS trials (INPULSIS-1 and INPULSIS-2). All these studies were randomized, double-blind, placebo-controlled trials comparing Ofev 150 mg twice daily to placebo for 52 weeks.