A clinical trial involving more than 1,200 participants at 374 sites in 17 countries has found that a new drug called benralizumab has the potential to safely improve outcomes for people with severe asthma.
The study, called SIROCCO, is published in the Sept. 5 issue of The Lancet Respiratory Medicine.
“Our results showed that benralizumab significantly reduced exacerbations and improved lung function with an acceptable safety profile for patients with severe uncontrolled asthma with eosinophilia,” said the study’s lead author, Eugene R. Bleecker, M.D., director of the Center for Genomics and Personalized Medicine Research at Wake Forest Baptist Medical Center.
According to the Centers for Disease Control and Prevention, asthma affects approximately 25 million people in the United States, with approximately 10 percent having severe or uncontrolled cases of the respiratory disease. Eosinophilia – an elevated level of white blood cells called eosinophils that causes inflammation and hyper-sensitivity in airways -- is present in approximately half of all asthma patients. The condition is associated with increased asthma severity, greater frequency of exacerbations (episodes of progressively worsening symptoms such as shortness of breath and wheezing) and decreased lung function.
Patients with severe asthma rely on high-dosage inhaled corticosteroids in combination with long-acting beta-agonists to control their disease. But this therapy is not effective in all asthmatics, leaving many with uncontrolled and ever-worsening cases, and can produce serious side-effects with frequent use.
Benralizumab is an antibody compound produced from a single “parent” cell developed by Medimmune, a U.S. subsidiary of the London-based pharmaceutical company AstraZeneca, to be a complimentary therapy for adults and adolescents with severe asthma.
To test the safety and efficacy of the medication, the researchers enlisted asthma patients ages 12 to 75 who had experienced two or more exacerbations in the previous year while taking corticosteroids and beta-agonists. The participants were randomly placed in three equal-sized groups to receive over a 48-week period 30 mg of benralizumab every four weeks, 30 mg every four weeks for the first three doses then the same dosage every eight weeks, or a placebo. Approximately two-thirds of the participants in each group had elevated eosinophil levels.
The study found that benralizumab decreased the annual exacerbation rate by as much as 51 percent relative to placebo while reducing symptoms and improving lung function in those participants with severe, uncontrolled asthma with eosinophilia. The drug also resulted in direct, rapid and nearly complete depletion of eosinophils at four weeks, the first sampling point. Overall, the every-eight-weeks dosage schedule proved either as or more effective than the every-four-weeks regimen.
“These findings indicate that the clinical benefit obtained from benralizumab translates into better asthma control and improved quality of life,” Bleecker said, noting that the results were consistent with those from a similarly designed 56-week clinical trial of benralizumab called CALIMA.
Both phase 3 trials were funded by AstraZeneca and the Japanese pharmaceutical and biotechnology company Kyowa Hakko Kirin.
Co-authors of the SIROCCO study are Mark FitzGerald, M.D., University of British Columbia Institute for Heart and Lung Health (Canada); Pascal Chanez, M.D., Aix Marseille University (France); Alberto Papi, M.D., University of Ferrara (Italy); Steven F. Weinstein, M.D., Allergy & Asthma Specialists Medical Group, Huntingdon Beach, Calif.; Peter Barker, Ph.D., Stephanie Sproul, M.Math., Mitchell Goldman, M.D., AstraZeneca, Gaithersburg, Md.; Geoffrey Gilmartin, M.D., Astra Zeneca, Cambridge, Mass.; Magnus Aurivillius, M.D., and Viktoria Werkstrom, M.D., Astra Zeneca, Gothenburg, Sweden.
Disclosure: Bleecker serves as a consultant for AstraZeneca.
Media Relations
Marguerite Beck: marbeck@wakehealth.edu, 336-716-2415