Long-term benralizumab use is efficacious for patients with severe, uncontrolled asthma with elevated eosinophil counts, according to study results published in the Journal of Asthma and Allergy.
Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody that causes nearly complete depletion of eosinophils as a result of enhanced antibody-dependent cell-mediated cytotoxicity.
Researchers explored whether benralizumab efficacy was sustained after an additional year of treatment while maintaining an acceptable safety profile by integrating data from 2 clinical trials (SIROCCO; ClinicalTrials.gov Identifier: NCT01928771 and CALIMA; ClinicalTrials.gov Identifier: NCT01914757) with a predefined 56-week extension study (BORA; ClinicalTrials.gov Identifier: NCT02258542). Patients received benralizumab 30 mg subcutaneously either every 4 or every 8 weeks.
Reductions in the occurrence of asthma attacks and improvements in lung function and asthma symptoms were maintained during the second year of benralizumab treatment with an acceptable and stable safety profile. Specifically, in patients with eosinophil counts ≥300 cells/µL, the prebronchodilator forced expiratory volume in 1 second from baseline increased to 0.343 L and 0.364 L in the first and second years of benralizumab treatment, respectively. In addition, patients experienced improvements in Asthma Control Questionnaire and Asthma Quality of Life Questionnaire scores.
One of the limitations of the study was the lack of placebo control during the second year of analysis.
“[T]he 2-year integrated analysis of efficacy and safety results from the SIROCCO, CALIMA, and BORA Phase 3 studies further supports the use of benralizumab for the treatment of patients with severe, uncontrolled asthma,” the researchers concluded. “This analysis will be important in guiding clinician decisions on the long-term use of benralizumab.”
Disclosure: This clinical trial was supported by AstraZeneca and Kyowa Hakko Kirin. Please see the original reference for a full list of authors’ disclosures.
FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab in severe asthma. J Asthma Allergy. 2019;12:401-413.