New analysis of patients with autoimmune-related ILDs in the INBUILD study shown as poster presentation at the 2019 ACR/ARP Annual Meeting

RIDGEFIELD, Conn., Nov. 7, 2019 /PRNewswire/ -- Boehringer Ingelheim presented results from a new subgroup analyses that support the primary endpoint results from the Phase III INBUILD^® trial that showed Ofev^® (nintedanib) reduced the rate of lung function decline in patients with autoimmune-related interstitial lung diseases (ILDs). This analysis is among 12 oral and poster presentations Boehringer Ingelheim shared from multiple nintedanib studies across systemic sclerosis-associated ILD (SSc-ILD) and fibrosing ILDs with a progressive phenotype at the 2019 ACR/ARP Annual Meeting, Nov. 8-13 in Atlanta.

"Interstitial lung diseases are a diverse group of conditions that can cause lung fibrosis and can have a devastating impact on patients," said Eric Matteson, M.D., author of poster and Emeritus Professor, division of rheumatology, Mayo Clinic College of Medicine and Science, Rochester, Minn. "Results from this analysis provide further insights into nintedanib's effect on the rate of lung function decline in patients with fibrotic interstitial lung diseases irrespective of their primary clinical diagnosis."

ILDs encompass a large group of more than 200 disorders that may involve the threat of pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function. The Phase III INBUILD trials evaluated patients with fibrosing ILDs with a progressive phenotype.

"The abstracts being presented at the 2019 ACR/ARP Annual Meeting offer a better understanding of nintedanib's effect across a variety of patients with fibrotic ILDs," said Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim. "As a leader in the field of ILD research, we are fully committed to better understand how to treat these devastating diseases."

INBUILD analysis
The Phase III INBUILD study is the first clinical trial in patients with ILDs to group patients based on the clinical characteristics of their disease, rather than the primary clinical diagnosis in patients with progressive fibrosing ILDs. The study met its primary endpoint of reducing the annual rate of decline in FVC (mL/year) over 52 weeks. The primary results were presented at the European Respiratory Society (ERS) congress in September.

This new analysis evaluated 171 patients who had ILDs related to an autoimmune disease, including rheumatoid arthritis (n=88), systemic sclerosis (n=40), and mixed connective tissue disease (n=20). Patients aged ≥ 18 years with a physician-diagnosed ILD other than idiopathic pulmonary fibrosis (IPF) and features of fibrosing lung disease of >10% extent on HRCT were randomized to receive 150 mg of nintedanib twice daily or matching placebo.

Results showed about half of patients had a relative decline in FVC ≥ 10% predicted in the 24 months before screening, and nearly three-quarters of patients (74.3%) had a UIP-like fibrotic pattern on HRCT. This pattern was most common in patients with rheumatoid arthritis-related ILD (87.5%). The most common adverse event reported was diarrhea, reported in 66.9% and 23.9% of patients treated with nintedanib and placebo, respectively.

Findings from the INBUILD study formed the basis of the supplemental new drug application (sNDA) that is currently under review by the FDA and which received Breakthrough Therapy Designation status from the U.S. FDA in October 2019.

About interstitial lung disease
Patients with ILDs can develop a progressive phenotype that causes pulmonary fibrosis, leading to lung function decline, deterioration in quality of life and early mortality similar to IPF, the most common form of interstitial lung disease. The course of the disease and the symptoms are similar in progressive fibrosing ILDs regardless of the underlying disease. Chronic hypersensitivity pneumonitis, connective tissue disease-related ILDs, sarcoidosis and idiopathic forms of interstitial pneumonia, are among these diseases.

About Ofev
Ofev is already approved in the U.S. and more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF) – the most common form of interstitial lung disease. In September 2019, Ofev was approved in the U.S. as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD. Submissions have been made to other major regulatory bodies across the globe.

What is Ofev?

• Ofev is a prescription medicine used:
  
• to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

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 add 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.

CL-OF-100024  09.06.19

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., 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 our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients' lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.

In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales.

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