INJOURNEY Trial Results Investigating Ofev with Add-On Pirfenidone Released

Results from the INJOURNEY trial, investigating the use of Ofev (nintedanib) in combination with pirfenidone in treating idiopathic pulmonary fibrosis (IPF), have now been published in the American Journal of Respiratory and Critical Care Medicine. Nintedanib is one of two antifibrotic drugs which have been shown to slow the progression of the disease in patients with IPF.

INJOURNEY was a 12-week, open-label, randomized trial evaluating the safety, tolerability and pharmacokinetics of nintedanib with add-on pirfenidone compared with nintedanib alone, in patients with IPF. Change in forced vital capacity (FVC), the established efficacy endpoint in IPF trials, was evaluated as an exploratory endpoint.

The scientific community has raised the question of whether a combination of both available drugs would be safe to use in IPF patients. The INJOURNEY trial evaluates these questions and is part of Boehringer Ingelheim's commitment to address this need. The data show that the safety and tolerability profile of nintedanib with add-on pirfenidone is consistent with the known profiles of the individual drugs in patients with IPF.

"Safety always comes first when considering the right medicine for the treatment of an individual IPF patient. The results from INJOURNEY help to close a gap on the questions of the safety, tolerability and possible interactions of adding pirfenidone to nintedanib background therapy in the treatment of IPF. Furthermore, the results are reassuring and supportive of future research on combination regimens with nintedanib in IPF," said Professor Carlo Vancheri, Professor of Respiratory Medicine, University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.

The primary endpoint of INJOURNEY was the percentage of patients with on-treatment gastrointestinal (GI) adverse events (AE) from baseline to week 12 of randomized treatment. Results show that the combination of nintedanib and pirfenidone resulted in a manageable safety and tolerability profile in the majority of patients. Diarrhea, nausea and vomiting were the most frequent adverse events, consistent with the safety profiles of the individual drugs, with a slightly higher incidence in the pirfenidone add-on group.  No new safety signals were observed in the combination treatment, and serious adverse events were uncommon in both treatment groups.

Results also indicate there may be a slower decline in FVC in patients treated with pirfenidone on the backbone of nintedanib compared with nintedanib alone, suggesting a potential benefit of the combination. However, further research will be necessary to fully evaluate the efficacy of the combination.

IPF is a rare and serious lung disease that causes permanent scarring of the lungs. It affects as many as 132,000 Americans, typically men over the age of 65. Early diagnosis and proper care are critical to helping people treat their condition.

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