MedicalResearch.com Interview with:
Gerard J. Criner, MD, FACP, FACCP
Chair and Professor, Thoracic Medicine and Surgery
Lewis Katz School of Medicine
MedicalResearch.com: What is the background for this study?
Response: 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.
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.
MedicalResearch.com: What are the main findings?
Response: 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.
MedicalResearch.com: What should readers take away from your report?
Response: The findings in these two trials suggest that eosinophil depletion may not completely ameliorate exacerbation outcomes for patients with COPD.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: in post hoc analysis; patients with a history of > 3 prior exacerbations or on triple inhaled therapy had greater effect on exacerbation reduction with treatment with 100 mg benra and a sensitivity analysis showed a > 40% reduction in severe exacerbations that required hosptilalization. Also baseline eosinophil levels > 300 cells were associated with a greater benra effect in those with treated with 100 mg dose. Future studies using these selection criteria may identify a patient group who may benefit from this therapy.
Exacerbations are a common problem in patients with COPD, but with hetergeneous mechnanisms involved that will need individualized treatments. Targeted therapies like benralizumab are an important step forward but more work is required to identify the patient population that will most benefit from this therapy.
MedicalResearch.com: Is there anything else you would like to add?
Response: Discovering treatments that prevent and/or limit exacerbations is a priority for clinicians and researchers to improve the quality of life for patients. WITH COPD Unfortunately benralizumab did not accomplish that objective in GALATHEA, but the findings will inform current and future avenues of exploration for new treatments
Study sponsored by AstraZeneca
Gerard J. Criner:
Received research grants from Boehringer Ingelheim, Novartis, AstraZeneca, Respironics, MedImmune, Actelion, Forest, Pearl, Ikaria, Aeris, Spiration, PneumRx, Chiesi, Mereo, GlaxoSmithKline, CSA Medical, Gala Therapeutics, Genentech, and Pulmonx
Received equity interest from HGE Health Care Solutions, Inc., and consultation fees from Almirall, Boehringer Ingelheim, Nuvaira, Novartis, AstraZeneca, Respironics, Pearl, Olympus, PneumRx, Chiesi, Mereo, GlaxoSmithKline, NGM Bio, CSA Medical, Zambon, Verona, Gala Therapeutics, and Pulmonx
Gerard J. Criner, Bartolome R. Celli, Christopher E. Brightling, Alvar Agusti, Alberto Papi, Dave Singh, Don D. Sin, Claus F. Vogelmeier, Frank C. Sciurba, Mona Bafadhel, Vibeke Backer, Motokazu Kato, Alejandra Ramírez-Venegas, Yu-Feng Wei, Leif Bjermer, Vivian H. Shih, Maria Jison, Sean O’Quinn, Natalya Makulova, Paul Newbold, Mitchell Goldman, Ubaldo J. Martin. Benralizumab for the Prevention of COPD Exacerbations. New England Journal of Medicine, 2019; DOI: 10.1056/NEJMoa1905248
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