– Data from this 12-week study showed that the safety and tolerability profile of Ofev® (nintedanib) with add-on pirfenidone is in keeping with the known profiles of the individual drugs in patients with IPF
– Exploratory efficacy analyses suggest a potential benefit of the combination treatment of nintedanib with add-on pirfenidone
– Results from INJOURNEY add to the body of evidence from a comprehensive clinical trial program demonstrating nintedanib’s safety and efficacy in IPF.
RIDGEFIELD, Conn., Sept. 11, 2017 /PRNewswire/ — 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. The prognosis of IPF is devastating, with 50% of patients dying within 3 years of diagnosis. 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.
Results from INJOURNEY
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.
“These new results suggest a potential benefit of the combination treatment of nintedanib with add-on pirfenidone in people with IPF, but that will need to be further evaluated,” said Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim. “As a company dedicated to respiratory care, we remain focused on continually uncovering new insights into IPF and to help support physicians as they have more informed treatment discussions with their patients.”
Boehringer Ingelheim has a strong commitment to scientific research with the goal of improving the care of people living with serious respiratory diseases. Our vision is to change progressive fibrosing lung diseases, such as IPF, from fatal diseases to chronic, treatable conditions, and our research continues to evolve treatment knowledge to help transform care for patients.
As part of our commitment, Boehringer Ingelheim is currently enrolling patients to participate in two further clinical trials exploring the full extent of the potential benefit of nintedanib in a broader range of progressive fibrosing lung conditions, other than IPF – SENSCIS™ and PF-ILD. The SENSCIS study (Safety and Efficacy of Nintedanib in Systemic SClerosIS) is the largest trial to date treating patients with systemic sclerosis (also known as scleroderma) who have also developed interstitial lung disease (SSc-ILD). The PF-ILD (progressive fibrosing interstitial lung disease) trial builds on the positive real-world clinical experience in IPF to determine whether nintedanib can effectively treat patients suffering from other progressive fibrosing-ILDs. It is the first trial in the field of ILDs that groups patients based on commonalities in pathophysiology and clinical behavior of their disease, rather than the specific diagnoses.
About idiopathic pulmonary fibrosis (IPF)
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.
About Ofev® (nintedanib)
The U.S. Food and Drug Administration (FDA) approved Ofev for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. Ofev is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.
The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW™ trial and the Phase III INPULSIS® trials (INPULSIS®-1 and INPULSIS®-2. All these studies were randomized, double-blind, placebo-controlled trials comparing Ofev 150 mg twice daily to placebo for 52 weeks. Both INPULSIS® trials were identically designed while the TOMORROW™ study design was similar.
What is Ofev?
Ofev is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). It is not known if Ofev is safe and effective in children.