Boehringer Ingelheim Pharmaceuticals, Inc. today announced the presentation of new analyses of OFEV for the treatment of idiopathic pulmonary fibrosis (IPF) at the Pulmonary Fibrosis Foundation’s PFF Summit 2015 in Washington, D.C. In 2014, OFEV became one of the first FDA-approved drug treatments for IPF, a rare and serious lung disease that causes permanent scarring of the lungs.
In a post-marketing surveillance study in the United States, treatment with OFEV in the real-world clinical setting showed a safety profile consistent with that observed in clinical trials supporting its approval by the FDA.
“The approval of OFEV was supported by evidence from three well-designed studies part of a comprehensive clinical trial program, and it is key to continually analyze the real-world experiences of people on therapy given the limited data on IPF,” said Imre Noth, M.D., Professor of Medicine and Director of the Interstitial Lung Disease Program at The University of Chicago, and lead author of the analysis. “These first results from the post-marketing surveillance study, which showed a consistent safety profile of OFEV as described in the prescribing information, are important because they provide healthcare providers with additional information when considering OFEV for their patients with IPF.”
First data from U.S. surveillance study
Post-marketing surveillance of the safety and tolerability of OFEV in the United States has been collected in the Boehringer Ingelheim drug safety and reporting database since OFEV was first approved on October 15, 2014. Until May 31, 2015, 3,838 people were treated with OFEV for a length of time ranging from 14 to 265 days (on average 88 days).
The most frequently reported side effects were gastrointestinal in nature and included diarrhea, nausea, vomiting and decreased appetite. Diarrhea was the most frequently reported individual side effect, occurring at a similar frequency to that observed in the clinical trials supporting approval. No new safety concerns were identified.
Researchers also presented two post-hoc analyses from an open-label, extension of the one-year Phase III INPULSIS™ studies, known as INPULSIS™-ON. People with IPF who completed the 52-week treatment period and a four-week follow-up period in the identically-designed INPULSIS™ trials were invited to receive open-label treatment with OFEV to assess its long-term safety and tolerability. INPULSIS®-ON included 734 participants (more than 90 percent of those completing the INPULSIS™ trials), including 304 people who initiated OFEV after receiving placebo in the Phase III trials and 430 people who were on OFEV in the INPULSIS™ trials and continued to receive treatment.
New results in people with IPF with severe lung impairment (NCT01619085)
The first analysis evaluated treatment effect in people with IPF who had severe lung impairment (less than 50 percent forced vital capacity [FVC] predicted). The Phase III INPULSIS™ studies excluded people with severe lung impairment; however, they were allowed to enter the extension study even if their lung function declined to severe levels during the initial one-year treatment period. The new analysis reports that, in patients treated with OFEV, a similar decline in lung function was observed in people with severe lung impairment when compared to people with mild to moderate impairment (greater than or equal to 50 percent predicted).
New long-term efficacy data in people with IPF (NCT01619085)
The second analysis suggests OFEV had a long-term effect on slowing FVC decline, a measure of disease progression, for approximately two years, or 100 weeks.
Overall, the most common adverse events were diarrhea, nausea, cough, common cold (nasopharyngitis), bronchitis, difficult or labored breathing (dyspnea), IPF disease progression, decreased appetite, weight decreased and vomiting. The most frequent serious adverse event reported was IPF, which includes disease worsening and acute exacerbations.
“At Boehringer Ingelheim, we are committed to improving the understanding of IPF and the role that OFEV plays in the treatment of this disease,” said Danny McBryan, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “Collectively, these analyses support the suggestion that OFEV continues to be effective out to approximately two years and that the decline in lung function is similar in people receiving OFEV with severe or mild to moderate impairment of lung function. These results add to our understanding of OFEV by providing insight into the impact over a longer period of time and in patients that were not included in the studies supporting its approval.”