BI’s INBUILD Study Results Reveal Potential for Ofev with Interstitial Lung Disease Fighting Lung Function Decline

Nov 13, 2019 | Interstitial Lung Diseases, Nintedanib, Pulmonary

FDA Approves Genentech’s Tecentriq for First-Line Non-Small Cell Lung Cancer

Boehringer Ingelheim’s Ofev (nintedanib) could help lower lung function rate of decline in those patients afflicted with interstitial lung diseases (ILDs) associated with autoimmune diseases, according to new analysis of the INBUILD® Phase III clinical trial.

The Study

The Phase III study sought to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD.

The study involved more than 600 participants with fibrosing ILDs—according to Marisa Wexler of Pulmonary Fibrosis News, is a group of over 200 conditions that may lead to scaring (fibrosis) in the lungs. The participants were treated with Ofev (150 mg twice per day) or a placebo for one year.

Previous data revealed that the trial showed that the primary objective—a slowing rate of lung function decline by more than 50% in those patients given Ofev—in fact was working.

No Efficacious Treatment

There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILB.

What is Ofev?

Made by German-based Boehringer Ingelheim, it is an anti-fibrotic therapy—a medication that lessens tissue scarring—that is already approved for the treatment of idiopathic pulmonary fibrosis (IPF) and scleroderma

Sponsor Presentations

Boehringer Ingelheim made 12 presentations regarding the new data on the use of Ofev as a treatment for ILDs at the American College of Rheumatology’s 2019 occurring in Atlanta November 8-13.

One of the posters is titled “The INBUILD Trial of Nintedanib in Patients with Progressive Fibrosing Interstitial Lung Diseases: Subgroup with Autoimmune Diseases,” in which investigators discuss 171 INBUILD trial participants with ILDs related to autoimmune diseases.

Lead Research/Investigator

Eric Matteson, MD, a co-author of the poster and professor at Mayo Clinic College of Medicine and Science


Pin It on Pinterest