Almost 37 percent of idiopathic pulmonary fibrosis patients who took Ofev for a year had no decline in a key measure of lung function, double the 18 percent of those on a placebo, according to one of three recent Ofev presentations in Washington.
The results of that study applied to a lung function measure known as forced vital capacity, or FVC. This is the amount of air a person can force from their lungs after a breath that fills their lungs to capacity.
The one dealing with FVC was titled “Improvement in Forced Vital Capacity (FVC) with Nintedanib in Patients with Idiopathic Pulmonary Fibrosis (IPF): Results from The INPULSIS Trials,”
Ofev was one of the first IPF therapies to win U.S. regulatory approval. The Food and Drug Administration based its decision in 2014 on results of the Phase 2 TOMORROW (NCT00514683) and Phase 3 INPULSIS (NCT01335464 and NCT01335477) trials.
The three presentations that Boehringer made at the Washington conference were based on additional information it gleaned from trials.
“At Boehringer Ingelheim, we are committed to IPF and broader ILD [interstitial lung disease] research and advancements to better understand these devastating diseases,” Dr. Thomas Leonard, head of Boehringer’s specialty care unit, said in a press release. “Through ongoing research, we are able to provide the IPF community with the information they need to make informed treatment decisions.”
The key finding in the FVC presentation was that 36.8 percent of IPF patients who received Ofev for a year had no decline in forced vital capacity, compared with 18 percent in the placebo group.
Another presentation dealt with Ofev’s ability to prevent IPF from progressing over the long term. It involved a subgroup of patients in the open-label INPULSIS-ON (NCT01619085) trial, some of whom were followed for up to 96 weeks. It showed that Ofev was able to prevent disease progression over the long term.
A third presentation dealt with whether taking Ofev would lead to a heart attack. It showed that the risk of a major cardiovascular event was the same in patients taking Ofev as in those taking a placebo.
The analysis was based on pooled data from the TOMORROW and INPULSIS studies. The presentation was titled “Cardiovascular Safety of Nintedanib in Subgroups by Cardiovascular Risk at Baseline in The TOMORROW and INPULSIS Trials.”
“IPF is a progressive disease that requires ongoing treatment,” said Dr. Imre Noth, director of the Interstitial Lung Disease Program at the University of Chicago. “So, it is important to assess the long-term efficacy and safety of IPF treatments like Ofev to ensure we are maintaining lung function and reducing disease progression while not exacerbating co-existing conditions.
“These new data help to further strengthen the science supporting the efficacy and safety of Ofev for up to 96 weeks of treatment, and offer physicians additional evidence to support their treatment decisions,” Noth added.
Boehringer is in the midst of conducting even more studies to confirm Ofev’s effectiveness against IPF and other lung diseases. Results of the first Phase 4 clinical trial (NCT02579603) since Ofev’s approval are expected to add to the evidence that Ofev is safe and tolerable in combination with Esbriet (pirfenidone).