The company used an imaging technique to check on Ofev’s anti-fibrotic properties. It was the first time it had used high-resolution computerized tomography, or HRCT, to do this with IPF patients.
Boehringer presented the results at the Pulmonary Fibrosis Foundation Summit in Nashville, Nov. 9-11. The presentation was titled “Effect of nintedanib on disease progression: results from a Phase IIIb trial in patients with idiopathic pulmonary fibrosis (IPF).”
Researchers used HRCT to measure both lung scarring and tissue thickening — hallmarks of fibrosis.
The primary objective of the trial (NCT01979952) was to see if Ofev would improve patients’ scores on a lung fibrosis index after six months of treatment. Researchers randomly assigned patients to either 150 mg of Ofev twice a day or a placebo.
The average fibrosis score of the Ofev-treated patients was 11.4 percent after six months, versus 14.6 percent for the placebo group. The difference of 3.2 percentage points in the scores was not statistically significant but did show Ofev’s potential for halting fibrosis progression.
“With the aid of high-resolution CT scans, we have observed a reduction in the progression of lung fibrosis with Ofev versus placebo,” Dr. Lisa Lancaster, director of the Interstitial Lung Disease Program at Vanderbilt University Medical Center, said in a press release. She was the study’s lead investigator.
“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,” Lancaster added.
Researchers also looked at changes in patients’ lung function, using a measure known as forced vital capacity. FVC is the amount of air a person can exhale after a deep breath.
After six months, the placebo group’s FVC scores were much lower than the Ofev group’s — that is, the control group could exhale much less air than the treated group. This indicated that lung function decline was greater in the placebo group.
The results matched those from four previous trials — the Phase 2 TOMORROW (NCT00514683) study, the Phase 3 INPULSIS studies (NCT01335464 and NCT01335477), and the INPULSIS-ON extension study (NCT01619085). The trials also showed that Ofev-treated patients ended up with better lung function than placebo patients.
“This [latest] study reaffirms the beneficial effect of Ofev for reducing lung function decline and slowing disease progression,” said Dr. Thomas Leonard, executive director of Boehringer Ingelheim’s Clinical Development and Medical Affairs Specialty Care program. The trial was also “the first to suggest that there may be a differential effect of Ofev treatment versus placebo in lung fibrosis change,” he said.
“We look forward to presenting additional findings from this study at major medical congresses next year and confirmation of these results in future studies,” Leonard added.
Both the U.S. Food and Drug Administration and the European Union have approved Ofev as a treatment for idiopathic pulmonary fibrosis.