New Analyses of Ofev® data in patients with chronic fibrosing ILDs available during American Thoracic Society Congress

Ridgefield, Conn., August 10, 2020 – Boehringer Ingelheim today announced new analyses of the Phase III INBUILD® trial that studied Ofev® (nintedanib) for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. These analyses were published online in conjunction with the American Thoracic Society (ATS) Virtual conference. The accepted abstracts are available here.

In an analysis of the INBUILD trial, the proportion of patients with 10% or greater declines in lung function were lower in the Ofev group relative to placebo. The analysis was based on changes between baseline and 52 weeks in the rate of decline in forced vital capacity (FVC) >5% and FVC >10% predicted. FVC is an established measurement of lung function and loss of FVC is an indicator of disease progression.

Ofev slowed decline in lung function (FVC % predicted) compared to placebo. Ofev reduced the percent of patients experiencing an absolute decline in FVC >5% predicted, 43.4% compared to 55% for placebo, at 52 weeks. Similarly, Ofev decreased the percent of patients demonstrating an absolute decline in FVC >10%, 28.3% compared to 36.6% for placebo, at 52 weeks.

“We are encouraged by these findings related to lung function decline seen with Ofev in patients with a progressive form of chronic fibrosing ILDs,” commented Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care IPF/ILD, Boehringer Ingelheim Pharmaceuticals, Inc. “These new results contribute to the growing scientific body of evidence supporting the use of Ofev.”

In a separate pre-specified analyses, the rate of decline in FVC (mL/year) over 52 weeks was assessed in subgroups based on the following baseline characteristics:

• Sex
• Age (<65, ≥65 years)
• Race (White, Asian, Black/African-American)
• FVC (≤70, >70% predicted)
• ILD diagnosis: hypersensitivity pneumonitis; autoimmune ILDs; idiopathic non-specific interstitial pneumonia (iNSIP); unclassifiable idiopathic interstitial pneumonia (IIP); other ILDs.

The analysis demonstrated that Ofev reduced the annual rate of decline in FVC in patients with chronic fibrosing ILDs, irrespective of demographic characteristics, lung function or ILD diagnosis at baseline.

“These results support the role of Ofev as a treatment for patients living with chronic fibrosing ILDs with worsening progression across varying demographic characteristics, lung function or diagnosis,” said Martin Kolb, M.D., Ph.D., professor, Division of Respirology, Department of Medicine, McMaster University in Hamilton, Ontario.

About the Phase III INBUILD trial
The INBUILD trial was a randomized, double-blind, placebo-controlled, parallel group trial conducted at 153 sites in 15 countries that evaluated the efficacy and safety of Ofev (150 mg, twice-daily) over 52 weeks in patients with chronic fibrosing ILDs with a progressive phenotype. A total of 663 patients were evaluated, of whom 412 (62.1 percent) had a usual interstitial pneumonia (UIP)-like pattern on high-resolution CT (HRCT). Randomization of patients was based on the fibrotic patterns as detected through HRCT. Lung function was assessed by the annual rate of decline in FVC.

Results showed that Ofev slowed the loss of pulmonary function by 57 percent (107 mL/year) across a range of patients relative to placebo. In patients with UIP-like fibrotic pattern on HRCT, results showed that treatment with Ofev-versus placebo slowed the loss of pulmonary function by 61 percent (128.2mL/year).

In the INBUILD trial, the safety and tolerability profile of Ofev was consistent with what was previously seen in IPF studies. The most common adverse reactions reported in greater than or equal to five percent in Ofev-treated patients compared to placebo were diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, weight decreased, headache, hypertension, nasopharygitis, upper respiratory tract infection, urinary tract infections, fatigue and back pain.

About chronic fibrosing ILDs with a progressive phenotype
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. Chronic fibrosing ILDs in which lung fibrosis continues to worsen are estimated to occur in 18 to 32 percent of patients with ILDs.

Unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, sjogren’s syndrome, coal workers pneumoconiosis and idiopathic forms of interstitial pneumonias such as idiopathic non-specific interstitial pneumonia are among the diseases that may develop a progressive form of chronic fibrosing ILD.

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. as the first and only therapy 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.

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