Idiopathic pulmonary fibrosis (IPF) patients treated with Ofev (nintedanib) are twice as likely to improve or see their disease stabilize than untreated patients, according to a pool of data from several clinical studies. Researchers also found Ofev to be safe for long-term treatment.
Results from an analysis of multiple Phase 2/3 clinical trials of Ofev sponsored by the drug’s developer, Boehringer Ingelheim Pharmaceuticals, were presented at the American Thoracic Society (ATS) 2017 International Conference.
The U.S. Food and Drug Administration approved Ofev as a therapy for IPF in 2014.
“IPF is a progressive disease that requires ongoing treatment,” Imre Noth, MD, professor of medicine and director of the Interstitial Lung Disease Program at the University of Chicago, said in a press release. “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.”
Two trials, called INPULSIS and INPULSIS-ON, were similar in design, dosage, inclusion criteria and endpoints, but the latter evaluated the safety and effectiveness of prolonged treatment with Ofev.
Data from Phase 3 trials (NCT01335464), called INPULSIS-1, and (NCT01335477), called INPULSIS-2, found that patients treated with Ofev had improved forced vital capacity (FVC), a standard measure of lung function, after 52 weeks of treatment. This was true for 36.8% of participants in the Ofev group compared to 18% in the placebo group.
The Phase 3 trial (NCT01619085), called INPULSIS-ON, showed a similar annual rate of FVC decline over 96 weeks among patients treated with Ofev.
Major adverse cardiovascular events (MACE) were tested with Ofev and a placebo in the Phase 2 study (NCT00514683), called TOMORROW. Most patients (90%) had increased risk of cardiovascular disease at baseline. The trial showed that the incidence of MACE was identical for both participant groups, and for patients with either a high or low risk of cardiovascular disease.
Boehringer also presented a separate analysis of data from the IPF-PRO patient registry at 18 pulmonary care sites of IPF patients with advanced lung function loss. In a six-minute walking distance test, these patients had greater physical impairment compared to those with mild to moderate IPF.
Patients with advanced IPF also had increased rates of low blood oxygenation at rest and while active, and higher incidence of high blood pressure in the lungs compared to those at less severe states of the disease. Health-related quality of life also was significantly worse in severe IPF patients.
“At Boehringer Ingelheim, we are committed to IPF and broader [lung disease] research and advancements to better understand these devastating diseases,” said Thomas Leonard, PhD, Boehringer’s executive director for Clinical Development and Medical Affairs. “Through ongoing research, we are able to provide the IPF community with the information they need to make informed treatment decisions.”