Boehringer Ingelheim presented new analyses showing OFEV® continued to be safe and tolerable for the treatment of idiopathic pulmonary fibrosis (IPF) in clinical use and in an extension study. The analyses were given at the Pulmonary Fibrosis Foundation’s PFF Summit 2015 in Washington, D.C., on Nov. 13.
OFEV approved by the FDA in October 2014 as one of the first therapies for IPF, an uncommon and severe lung disease that can result in permanent lung scarring.
“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, MD, professor of Medicine and director of the Interstitial Lung Disease Program at The University of Chicago, and first author of the study, in a news release. “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.”
The real-world clinical setting (post-marketing) report revealed that 3,838 patients received OFEV treatment as of May 31, 2015, for lengths of time ranging from 14 to 265 days (88-day average). Reported side effects were mainly of a gastrointestinal nature, such as diarrhea, nausea, vomiting and decreased appetite, with diarrhea being the most reported adverse effect. These accorded with the side effects observed during clinical trials, leading to no new identification of safety concerns.
The researchers also presented two analyses of the already concluded Phase 3 INPULSIS trial, under a trial extension known as INPULSIS–ON. This extension study, assessing long-term safety and tolerability, involved 734 patients (over 90% of those who completed INPULSIS ), with 304 placebo patients initiating OFEV and remaining 430 continuing with OFEV treatment.
A first analysis reported on the treatment’s effect in IPF patients with severe lung impairment (less than 50% forced vital capacity (FVC) expected), a patient group disqualified in the initial Phase 3 trials but allowed back into the extension study. This analysis found a similar decline was observed in patients with severe lung impairment when compared to those with a milder or medium impairment (>50% expected).
The second analysis led the team to suggest that OFEV had the long-term ability — shown at 100 weeks, or almost two years — to slow FVC deterioration, a measure of disease progression. Common side effects ranged from diarrhea, nausea, cough, common cold (nasopharyngitis), bronchitis, to loss of appetite and vomiting. The most frequent report was the worsening and acute exacerbation of IPF.
A combined analysis of INPULSIS data among IPF patients given decreased doses of OFEV — from 150 mg to 100 mg two times a day, or interrupted treatment to manage side effects — and those who maintained original dosing levels showed no change in efficacy. Particularly, the investigators said that OFEV had similar results on FVC decline in cases of reduction or interruption greater than or equal to one dose, and less than or equal to 90 percent dose intensity.
Said Danny McBryan. MD, vice president of Clinical Development and Medical Affairs, Respiratory, at Boehringer Ingelheim, “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.”