MedicalResearch.com Interview with:
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.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The aim of Boehringer Ingelheim’s INJOURNEY trial was to investigate the safety profile of Ofev (nintedanib) in combination with pirfenidone in treating patients with idiopathic pulmonary fibrosis (IPF). Nintedanib and pirfenidone, the only two FDA-approved drugs for the treatment of IPF, are able to slow down the progression of the disease, reducing the forced vital capacity (FVC) decline of about 50%, but this is not a cure. The target for the future is to have even more effective treatments. In the meanwhile, it is necessary to optimize the use of the available drugs. The medical treatment of other pulmonary diseases such as COPD, asthma or pulmonary hypertension is already based on different combinations of drugs.
This 12-week, open-label, randomized study was designed to evaluate the safety, tolerability and pharmacokinetics of nintedanib with add-on pirfenidone, compared with nintedanib alone in patients with IPF. Change in FVC, the established efficacy endpoint in IPF trials, was evaluated as an exploratory endpoint.
The primary endpoint of the INJOURNEY trial was the percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12 of randomized treatment, and the results showed that the combination of nintedanib and add-on pirfenidone resulted in a manageable safety and tolerability profile, similar to the profile of each drug individually in the majority of patients. Results also indicated there may be a slower decline in FVC in patients treated with pirfenidone along with 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.
MedicalResearch.com: What should readers take away from your report?
Response: These results showed that the combination of nintedanib and pirfenidone resulted in a manageable safety and tolerability profile in the majority of patients. 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, potentially representing a future therapeutic strategy. With an appropriate and larger study specifically investigating the efficacy of the combination, this may be possible.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Continued research will be key to continuing to understand fibrosing lung diseases like IPF and advance patient care in this disease space. While these data 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, further large controlled studies are needed to confirm the benefit risk ratio of combination antifibrotic therapy in patients with IPF.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: Nintedanib with add-on pirfenidone had a manageable safety and tolerability profile in this study among patients with IPF, in line with the adverse event profiles of each drug individually, and these data support further research into combination regimens in the treatment of IPF.
When given as monotherapy to patients with IPF, nintedanib and pirfenidone reduced the rate of decline in lung function by approximately 50%. In the INJOURNEY trial, there was a smaller numerical decline in FVC over 12 weeks in patients treated with nintedanib with add-on pirfenidone than with nintedanib alone. However, as this trial was not powered for this endpoint and was too short for conclusions to be drawn about the efficacy of combination therapy, these findings should be further evaluated.
Clinical trial information is available here or by visiting www.clinicaltrials.gov, ID NCT02579603.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.