image: Gerard J. Criner, M.D., FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University, Director of the Temple Lung Center at Temple University Hospital and corresponding author on the new paper. view more
Credit: Lewis Katz School of Medicine at Temple University
(Philadelphia, PA) - More than 15.3 million people in the U.S. suffer from chronic obstructive pulmonary disease (COPD), which is the third leading cause of death in this country, according to the American Lung Association. Patients often experience potentially life-threatening exacerbations, which can include days-long flare-ups of symptoms including shortness of breath that occur when the airways narrow from muscle tightness, swelling and mucus.
New research published online May 20 by the New England Journal of Medicine and co-led by Temple's Gerard J. Criner, MD, FACP, FACCP shows that the asthma drug benralizumab failed to decrease annual COPD exacerbation rates for patients with moderate to very severe COPD, a history of frequent moderate and/or severe exacerbations, and eosinophilic inflammation. Eosinophilic inflammation occurs when a type of white blood cells known as eosinophils, which help fight off infections and play a role in the body's immune response, build up in one location. Eosinophilic inflammation is associated with an increased exacerbation risk. The research was co-led by Bartolome R. Celli, MD, from the Pulmonary and Critical Care Division at Brigham and Women's Hospital, Harvard Medical School, Boston, MA, and was published in conjunction with a presentation at the American Thoracic Society International Conference 2019.
"COPD is a life-altering condition that causes serious long-term disability for patients," said Dr. Criner, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University, Director of the Temple Lung Center and corresponding author on the study. "Discovering treatments that prevent and/or limit exacerbations is a priority for clinicians and researchers as we seek to improve the quality of life for patients. Unfortunately benralizumab did not accomplish that objective in these studies, but the findings will inform current and future avenues of exploration for new treatments."
The Phase III, randomized, double-blind, placebo-controlled, parallel-group clinical trials GALATHEA and TERRANOVA evaluated the efficacy and safety of benralizumab for the prevention of exacerbations in patients with moderate to very severe COPD, eosinophilic inflammation, and increased risk of exacerbations. Benralizumab is a type of drug called an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody. It is approved by the FDA for the treatment of severe eosinophilic asthma.
An earlier, Phase II trial of benralizumab found a non-statistically significant reduction in COPD exacerbation rate for patients with eosinophilic inflammation in the airways. In this Phase III trial, the researchers sought to discover whether benralizumab's ability to deplete the airways of blood eosinophils in patients with eosinophilic inflammation would lead to a reduction in COPD exacerbations.
More than 3,000 patients aged 40-85 who met the inclusion criteria were randomized across the two studies at hundreds of sites around the globe. Patients received placebo or benralizumab via subcutaneous injection every 4 weeks for the first three doses, then every 8 weeks thereafter during the 56-week treatment period.
"The findings in these two trials suggest that eosinophil depletion may not completely ameliorate exacerbation outcomes for patients with COPD," added Dr. Criner. "However, as one of the nation's premier lung-disease research centers, the Temple Lung Center continues to investigate alternative treatment options and offer patients access to leading-edge clinical trials."
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GALATHEA and TERRANOVA were sponsored by AstraZeneca, which manufactures benralizumab and markets it under the name Fasenra. MedImmune, LLC was a collaborator on the studies. MedImmune is the global biologics research and development arm of AstraZeneca.
Editor's Note: Dr. Gerard Criner has received consulting monies from AstraZeneca.
About Temple Health
Temple University Health System (TUHS) is a $2.1 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. The Health System consists of Temple University Hospital (TUH), ranked among the "Best Hospitals" in the region by U.S. News & World Report; TUH-Episcopal Campus; TUH-Northeastern Campus; Fox Chase Cancer Center, an NCI-designated comprehensive cancer center; Jeanes Hospital, a community-based hospital offering medical, surgical and emergency services; Temple Transport Team, a ground and air-ambulance company; and Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices. TUHS is affiliated with the Lewis Katz School of Medicine at Temple University, and Temple University Physicians, which is Temple Health's physician practice plan comprised of more than 500 full-time and part-time academic physicians in 20 clinical departments.
The Lewis Katz School of Medicine (LKSOM), established in 1901, is one of the nation's leading medical schools. Each year, the School of Medicine educates more than 800 medical students and approximately 240 graduate students. Based on its level of funding from the National Institutes of Health, the Katz School of Medicine is the second-highest ranked medical school in Philadelphia and the third-highest in the Commonwealth of Pennsylvania. According to U.S. News & World Report, LKSOM is among the top 10 most applied-to medical schools in the nation.
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Journal
New England Journal of Medicine