Study analysis available during ATS 2021 supports long-term treatment with Ofev® in patients with systemic sclerosis-associated interstitial lung disease

Ridgefield, Conn., May 14, 2021 – Boehringer Ingelheim today announced results from an analysis of the SENSCIS®-ON trial. SENSCIS-ON is an open-label extension trial of the Phase III SENSCIS® study to assess the long-term tolerability and safety of Ofev® (nintedanib) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The study also evaluated the change from baseline in forced vital capacity (FVC), a measure of lung function, over 52 weeks. 

These findings, along with nearly 20 abstracts around interstitial lung diseases, were published online in conjunction with the ATS 2021 International Conference. The accepted abstracts are available at https://www.thoracic.org/.

“The depth and breadth of research findings from our interstitial lung disease program that we presented at this year’s ATS builds on our company’s legacy and commitment to respiratory medicine for the past 100 years,” said Craig Conoscenti, M.D., Medical Expert and Chronic Fibrotic Interstitial Lung Disease Program Lead, Clinical Development and Medical Affairs, at Boehringer Ingelheim Pharmaceuticals, Inc.

SENSCIS-ON
In an analysis of SENSCIS-ON, the safety profile of Ofev in participants who continued therapy for an additional 52 weeks was consistent with that observed during the SENSCIS trial. Approximately two-thirds of patients continuing Ofev either maintained stable FVC (~44%) or had an improvement in FVC (~20%) based on FVC changes from baseline to week 52.

“The SENSCIS-ON trial provides important new evidence about the longer-term use of nintedanib in people living with SSc-ILD, showing a sustained reduction in lung function decline with a manageable safety profile,” said Kristin B. Highland, M.D., director of the Rheumatic Lung Disease Program at the Cleveland Clinic, and a lead author of the SENSCIS-ON study. “These new data builds on the data already available on the use of nintedanib in SSc-ILD patients and should provide physicians with important information that will help them as they treat this serious, often life-threatening lung disease.”

New insights on IPF management
At ATS 2021, Boehringer Ingelheim also announced several abstracts from the Idiopathic Pulmonary Fibrosis – PROspective Outcomes (IPF-PRO) Registry. This is one of the largest patient registries in IPF designed to better understand the natural progression of, and treatment approaches to IPF. IPF-PRO is a unique collaboration between Boehringer Ingelheim and the Duke Clinical Research Institute that is building on the knowledge from multiple clinical sites in the US.

Analyses from three separate abstracts of the IPF-PRO Registry demonstrated the following:

• Treatment of IPF at specialized centers using ILD-related quality improvement projects was associated with a lower risk of hospitalization. Quality improvement projects are initiatives to enhance the care of patients through best practices and education of providers, patients and caregivers. 
• Across the registry, 6.3% of IPF patients received all the guideline-recommended services and interventions that they were eligible to receive. These were primarily patients with more severe disease. But when adjusted for disease severity, no association was found between the implementation of management guidelines and clinical outcomes.
• 56.7% of patients in IPF-PRO were hospitalized at least once during follow up. While median FVC was comparable in hospitalized (69.2% predicted) and non-hospitalized patients (71.4% predicted), a greater proportion of hospitalized vs. non-hospitalized patients were current or former smokers (70.6% vs. 61.9%), and used oxygen at rest (22.9% vs. 15.9%) and/or during activity at enrollment (38.9% vs. 28.4%).

“The IPF-PRO Registry continues to provides critical insights into the current management of IPF patients that will help clinicians improve the care of people living with this disease,” said Dr. Conoscenti.

About ILD
Interstitial lung diseases encompass more than 200 disorders that can lead to pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function.

Systemic sclerosis, also known as scleroderma, is a rare autoimmune disease characterized by thickening and scarring of connective tissue throughout the body. The disease is estimated to affect about 100,000 people in the U.S. and 2.5 million worldwide. Fibrosis, the hallmark of the disease, can affect the skin and internal organs, including the lungs. Interstitial lung disease (ILD), one of the most frequent disease manifestations, can be debilitating and may become life-threatening. Approximately 25 percent of patients develop significant lung involvement within three years of diagnosis. ILD is the leading cause of death among people with SSc.

IPF, a common type of ILD, is a serious lung condition that causes progressive scarring of the lungs, which over time makes it difficult to breathe. Symptoms of IPF include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness. Although considered “rare,” IPF affects up to 132,000 Americans, and about 50,000 people in the U.S. are diagnosed every year with IPF.

About Ofev
Ofev is already approved in the U.S. and more than 80 countries for the treatment of patients living with IPF. In September 2019, Ofev was approved in the U.S. to slow the rate of decline in pulmonary function in patients with SSc-ILD, and then in March 2020 to treat patients with chronic fibrosing ILDs with a progressive phenotype.

What is OFEV?

• OFEV is a prescription medicine used:
  • to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
    or
  • to treat people with a chronic (long lasting) interstitial lung disease in which lung fibrosis continues to worsen (progress).
    ​or
  • to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
• 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 highly effective birth control during and for at least 3 months after your last dose. Talk with your doctor about what birth control method is right for you during this time. Women using hormonal birth control should also use a barrier method of birth control (such as male condoms or spermicide). If you become pregnant or think you are 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 about all of your medical conditions, including 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.

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, and 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, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and 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 one 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, 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 http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, with around 52,000 employees, we create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2020, Boehringer Ingelheim achieved net sales of around 22.33 billion USD (19.57 billion EUR). Our significant investment of over 4.2 billion USD (3.7 billion EUR) in 2020 (18.9% of net sales) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

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