Results from the INJOURNEY™ trial investigating Ofev® with add-on pirfenidone provide new insights into this combination treatment for IPF

Ridgefield, Conn., September 11, 2017 – 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.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Ofev (nintedanib)?

Ofev can cause harm, birth defects or death to an unborn baby. Women should not become pregnant while taking Ofev. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use birth control during and for at least 3 months after your last dose. If you become pregnant while taking Ofev, tell your doctor right away.

What should I tell my doctor before using Ofev?

Before you take Ofev, tell your doctor if you have:

• liver problems
• heart problems
• a history of blood clots
• a bleeding problem or a family history of a bleeding problem
• had recent surgery in your stomach (abdominal) area
• any other medical conditions.

Tell your doctor if you:

• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Ofev passes into your breast milk. You should not breastfeed while taking Ofev.
• are a smoker. You should stop smoking prior to taking Ofev and avoid smoking during treatment.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements such as St. John’s wort.

What are the possible side effects of Ofev?

Ofev may cause serious side effects. 

TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:

• Liver problems. Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal or feeling tired. Your doctor will do blood tests regularly to check how well your liver is working during your treatment with Ofev.
• Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements. 
• Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath. 
• Stroke. Symptoms of a stroke may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
• Bleeding problems. Ofev may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
• Tear in your stomach or intestinal wall (perforation). Ofev may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.

The most common side effects of Ofev are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

These are not all the possible side effects of Ofev. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information, including Patient Information.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.  

MPR-US-100081