Today in the American Journal of Respiratory and Critical Care Medicine
, new data from the INJOURNEY trial was published, highlighting the safety and efficacy profile of OFEV (nintedanib) in combination with Esbriet (pirfenidone) in idiopathic pulmonary fibrosis (IPF) patients.
The 12-week, open-label, randomized trial was intended to investigate the safety and tolerability, as well as pharmacokinetic and exploratory efficacy endpoints in patients treated with nintedanib and add-on pirfenidone compared to nintedanib alone. The goal of the study’s lead authors, Carlo Vancheri and colleagues, is to show that the safety and tolerability profile of nintedanib with add-on pirfenidone is in keeping with the known profiles of the individual drugs prescribed to patients with IPF.
Patients with IPF have difficulty breathing because of permanent scarring in the lungs. Dry and persistent coughing, chest discomfort, and fatigue and weakness are among the primary symptoms, and since they are more commonly associated with common diseases like chronic obstructive pulmonary disease (COPD), asthma, or congestive heart failure, IPF often goes misdiagnosed.
The prognosis of the condition is devastating with more than half of all patients dying within 3 years of diagnosis.
The primary endpoint of the study was the percentage of patients with on-treatment gastrointestinal adverse events (AEs) from baseline to week 12 of randomized treatment. More specificially, gastrointestinal AEs were reported in 70% treated with nintedanib with add-on pirfenidone and in 52.9% treated with nintedanib alone.
Change in forced vital capacity (FVC) was evaluated as an exploratory endpoint and at the end of the 12 week study. Mean changes from baseline in FVC were −13.3 mL and −40.9 mL in patients treated with nintedanib plus pirfenidone (n=48) and nintedanib alone (n=44), respectively.
The results of the study prove that the combination of nintedanib and pirfenidone result in a manageable safety and tolerability profile in most patients, and that there may be a slower decline in FVC in patients treated with pirfenidone and nintedanib, instead of nintedanib alone This suggests that combining the drugs could be beneficial to the patient.
“We are dedicated to our research in idiopathic pulmonary fibrosis, which is a progressive and deadly condition. Nintedanib’s long-term impact on slowing disease progression, combined with its role in reducing the risk of acute IPF exacerbations, make it a logical first choice IPF treatment,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Respiratory, Boehringer Ingelheim in a press release
. “These new data provide a rationale for further research into combination regimens with nintedanib as a backbone treatment.”
Nausea, vomiting and diarrhea were the most frequent AEs, consistent with the safety profiles of the individual drugs, with a slightly higher incidence in the pirfenidone add-on group.
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