Safety and efficacy results from the INJOURNEYTM trial investigating OFEV® (nintedanib) with add-on pirfenidone provide new data to support nintedanib’s key role in IPF

Results from the INJOURNEY^TM trial, investigating the use of nintedanib in combination with pirfenidone in treating idiopathic pulmonary fibrosis (IPF), have just been published in the American Journal of Respiratory and Critical Care Medicine. ¹ The prognosis of IPF is devastating, with 50% of patients dying within 3 years of diagnosis.² Nintedanib is one of two antifibrotic drugs which have been shown to slow the progression of the disease in patients with IPF.³

INJOURNEY^TM was a 12-week, open-label, randomised trial evaluating the safety, tolerability, and pharmacokinetics of nintedanib with add-on pirfenidone compared with nintedanib alone, in patients with IPF.¹ Change in forced vital capacity (FVC), the most established efficacy endpoint in IPF trials, was evaluated as an exploratory endpoint.

Although more slowly, IPF continues to progress in the majority of patients despite effective treatment. Like other chronic diseases, pulmonologists consider combination therapy as an attractive strategy to further improve treatment outcomes. The scientific community has raised the question of whether a combination of both available drugs would be safe to use in IPF patients.² The INJOURNEY^TM trial provides answers to 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.¹

“Safety always comes first when considering the right medicine for the treatment of an individual IPF patient. The results from INJOURNEY^TM 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^TM was the percentage of patients with on-treatment gastrointestinal (GI) adverse events (AE) from baseline to week 12 of randomised treatment.¹ Results show that the combination of nintedanib and pirfenidone resulted in a manageable safety and tolerability profile in the majority of patients.¹ Diarrhoea, 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.¹ No new safety signals were observed in 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.¹ However, further research will be necessary to fully evaluate the efficacy of the combination.

“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. These new data provide a rationale for further research into combination regimens with nintedanib as a backbone treatment,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Respiratory, Boehringer Ingelheim.

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^TM and PF-ILD*. The SENSCIS^TM 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).⁴ 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.⁵ It is the first trial in the field of ILDs which groups patients based on commonalities in pathophysiology and clinical behaviour of their disease, rather than the specific diagnoses.

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* Nintedanib is currently not approved for use in SSc-ILD or PF-ILD (other than IPF) and its safety and efficacy has not yet been established.

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Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/press-release/injourney-results

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