New data from the analysis of trial INPULSIS™-ON, describing the long-term efficacy and side-effects of OFEV in the treatment of idiopathic pulmonary fibrosis (IPF), was presented at the European Respiratory Society (ERS) International Congress 2015.
IPF is a type of interstitial lung disease, affecting the tissue that supports the alveoli in the lung. It is characterized by the inflammation or accumulation of scar tissue, denominated fibrosis, in the lung and leads to progressive loss of elasticity, failure of proper lung activity and consequently insufficient oxygenation of the bloodstream and organs. The term idiopathic relates to the disease cases where the cause is unknown. Due to the seriousness and rarity of this condition, early diagnosis and appropriate therapy are essential for patient care, and research in this field is very active. There is no cure for IPF and the fibrosis progress varies from patient to patient.
Existent medication includes OFEV (nintedanib, Boehringer Ingelheim), a kinase inhibitor taken in the form of capsules that was approved by the FDA in October 2014. In two phase III trials, INPULSIS™-1 and INPULSIS™-2, this drug was shown to be effective and safe, slowing down the rate of lung scarring and loss of function. Gastrointestinal side effects are the most frequent adverse events of this therapy.
INPULSIS™-ON, an open-label extension trial, showed consistent results regarding efficacy and safety with the two previous phase III trials. Eric White, M.D., Associate Professor of Medicine, Pulmonary and Critical Care, University of Michigan Health System, commented on the relevance of this extension trial and on the results presented, “These data are significant because they provide additional evidence that OFEV maintains its safety profile and efficacy at slowing IPF disease progression over approximately two years, reinforcing the previously-reported one-year Phase III data,” said Dr. White in a news release, “Studies like INPULSIS™-ON are important because they inform us about the longer-term safety and efficacy of OFEV. IPF is a chronic disease that oftentimes requires long-term treatment. Evidence that OFEV maintains its clinical effect in the absence of any new safety signals provides me with more information to discuss with my patients considering treatment with OFEV.”
The main results of this study, with participation of IPF patients from two previous trials, show that OFEV treatment has long-term efficacy in slowing down disease progression. This effect is measured by annual rate of forced vital capacity (FVC) decline, and results from INPULSIS™-ON at 48 weeks are comparable with those of the two previous trials at 52 weeks. Long-term treatment tolerability was also evaluated and no new adverse effects were reported in patients continuing the treatment with OFEV. It is important to notice that serious adverse events were reported in 41.9 per cent of the patients continuing the treatment with OFEV, as opposed to 39.5 per cent in patients initiating the treatment. On the other hand, drug discontinuation due to adverse events was reported to be around 5 per cent: 2.3 percent for patients continuing treatment and 9.5 percent for patients beginning treatment.
The effect of OFEV with other common treatments in patients with IPF was also evaluated, namely with corticosteroids and anti-acid medication used for gastroesophageal reflux disease (GERD) management. Results show that OFEV reduced the annual decline in lung function in patients with IPF, independently of corticosteroid use, and that anti-acid medication did not influence the treatment effect of OFEV, as described in the abstracts presented at the ERS 2015 congress.