How effective is Ofev for pulmonary fibrosis?

Results from three, 52-week long clinical studies in 1,231 people with idiopathic pulmonary fibrosis (IPF) showed that Ofev 150 mg orally twice daily significantly reduced the decline in the Forced Vital Capacity (FVC) by about 50% and 68% over 52 weeks when compared to a group of people not taking Ofev. FVC measures the amount of air which you can forcibly exhale from your lungs after taking the deepest breath possible.

Study results for Ofev

Researchers conducted 3 studies over 52 weeks, INPULSIS-1, INPULSIS-2, and TOMORROW, to determine how well Ofev worked in patients with idiopathic pulmonary fibrosis (IPF). They measured the effectiveness of Ofev by measuring the annual rate of decline of Forced Vital Capacity (FVC) in milliliters (mL) compared to the decline in FVC in people taking inactive (placebo) pills.

In INPULSIS-1 and INPULSIS-2, Ofev was shown to slow the decline of lung function by about 50% when compared to a placebo pill (in those not taking Ofev).

• INPULSIS-1: -115 mL with Ofev (vs. -240 with placebo) = 125 mL/year less decline vs. placebo (95% confidence interval [CI] 77.7 to 172.8; P<0.001)
• INPULSIS-2: -114 mL with Ofev (vs. -207 with placebo) = 94 mL/year per less decline vs. placebo (95% CI, 44.8 to 142.7; P<0.001).

In the TOMORROW study, Ofev was shown to slow the decline of lung function by about 68% when compared to a placebo pill (in those not taking Ofev).

• TOMORROW: -60 mL with Ofev (vs. -191 with placebo) = 131 mL/year less decline vs. placebo.

Ofev appears to prevent acute IPF exacerbations, such as lung scarring that worsens the ability to breath and slows IPF progression (worsening), but is not considered a cure.

In the INPULSIS-2 trial, participants taking Ofev capsules were 80% less likely to have an acute exacerbation during a 1-year period than those not taking the drug (7.3% vs 1.5%, respectively).

Ofev is called an antifibrotic therapy, which is a drug that decreases the formation of scar tissue in the lungs, also called fibrosis. Other nondrug treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.

Related: How quickly does Ofev start working?

What is Ofev approved to treat?

Ofev (nintedanib) is an oral prescription medicine in a group of drugs known as tyrosine kinase inhibitors (TKIs). It is thought to block multiple pathways that may be involved in the scarring of lung tissue (called pulmonary fibrosis).

It is approved by the FDA to treat adults with:

• idiopathic pulmonary fibrosis (IPF), a lung disease.
• long-lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen
• systemic sclerosis-associated interstitial lung disease (SSc-ILD), also known as scleroderma-associated ILD, to help slow the rate of lung function decline.

Idiopathic pulmonary fibrosis (IPF) is an incurable lung disease in which the cause is not known and few treatment options exist. Idiopathic pulmonary fibrosis (IPF) occurs when the lungs become progressively scarred over time. As a result, patients with IPF may have shortness of breath, cough, and have difficulty participating in everyday physical activities.

It is not known if Ofev is safe and effective in children.

The most common side effects associated with Ofev include:

• Diarrhea
• Nausea
• Stomach-area (abdominal) pain
• Vomiting
• Liver toxicity (elevated liver enzymes)
• Decreased appetite
• Headache
• Weight loss
• High blood pressure

This is not a complete list of side effects or warnings. To learn more, read the Ofev medication information written for patients at Drugs.com.

This is not all the information you need to know about Ofev for safe and effective use and does not take the place of your doctor’s directions. Review the full Ofev information and discuss this information and any questions you have with your doctor or other health care provider.