Ofev (nintedanib) slows the rate of decline in lung function in people with interstitial lung diseases (ILDs) associated with autoimmune diseases, a new analysis of data from a Phase 3 clinical trial suggests.
The Phase 3 INBUILD trial (NCT02999178) involved more than 600 people with fibrosing ILDs — a group of over 200 conditions that may lead to scarring (fibrosis) in the lungs — who were treated with either Ofev (150 mg twice per day) or a placebo for one year. The trial was funded by Boehringer Ingelheim, Ofev’s manufacturer.
Previously reported data demonstrated that the trial met its overall primary objective, slowing the rate of lung function decline by more than 50% in those given Ofev.
Boehringer Ingelheim is making 12 presentations regarding new data on the use of Ofev as a treatment for ILDs at the American College of Rheumatology’s 2019 Annual Meeting, taking place Nov. 8–13 in Atlanta.
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Among them is a poster titled, “The INBUILD Trial of Nintedanib in Patients with Progressive Fibrosing Interstitial Lung Diseases: Subgroup with Autoimmune Diseases,” in which researchers focused on 171 INBUILD trial participants with ILDs related to autoimmune diseases — conditions in which the immune system attacks the body’s normal cells. Findings were also published in The New England Journal of Medicine, in the study “Nintedanib in Progressive Fibrosing Interstitial Lung Diseases.”
The most common autoimmune disease-associated ILDs in this group were rheumatoid arthritis-associated ILD (88 people), scleroderma-associated ILD (40 people), and mixed connective tissue disease ILD (20 people).
The average age of the group was 64.3 years at the start of the trial, about half of the participants were female, and almost all participants were either white (66.7%) or of Asian descent (29.8%).
A little more than half (51.5%) of this group experienced a decline in lung function, as measured by a drop in forced vital capacity (FVC) of 10% or more in the two years before the start of the trial.
Nearly three-quarters of the patients (74.3%) had an usual interstitial pneumonia-like pattern — a pattern associated with pulmonary fibrosis — on high-resolution computed tomography scans before the trial began. This pattern was particularly common among participants with rheumatoid arthritis-related ILD, appearing in 87.5% of them.
Data show that Ofev treatment can reduce the rate of decline in lung function in people with ILDs associated with autoimmune diseases; over 52 weeks of treatment, the annual adjusted rate of FVC decline was −80.8 ml in Ofev-treated patients and −187.8 ml in those given placebo.
“[W]e found that patients who received nintedanib had a slower rate of progression of interstitial lung disease than those who received placebo, independent of the fibrotic pattern on high-resolution CT [computed tomography],” the researchers wrote.
The most common side effect reported was diarrhea, affecting 66.9% of trial participants treated with Ofev and 23.9% of those given the placebo. More Ofev-treated patients either asked to lower their dose than did those in the placebo group (33.1% vs. 4.2%), or to stop their treatment (19.6% vs. 10.3%). But fewer people using Ofev died during the trial, 3.3% vs. 5.1%, than people on placebo.
“Interstitial lung diseases are a diverse group of conditions that can cause lung fibrosis and can have a devastating impact on patients,” Eric Matteson, MD, a co-author of the poster and professor at the Mayo Clinic College of Medicine and Science in Rochester, Minnesota, said in a press release.
“Results from this analysis provide further insights into nintedanib [Ofev]’s effect on the rate of lung function decline in patients with fibrotic interstitial lung diseases irrespective of their primary clinical diagnosis,” Matteson added.
Ofev recently received breakthrough therapy designation from the U.S. Food and Drug Administration as a potential therapy for progressive fibrosing ILD.
“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, PhD, executive director of clinical development and medical affairs, specialty care at Boehringer Ingelheim. “As a leader in the field of ILD research, we are fully committed to better understand how to treat these devastating diseases.”