Journal
JOURNAL OF ASTHMA AND ALLERGY
Volume 12, Issue -, Pages 21-33Publisher
DOVE MEDICAL PRESS LTD
DOI: 10.2147/JAA.S190221
Keywords
asthma; benralizumab; eosinophils; interleukin-5 receptor; monoclonal antibody; patient-reported outcomes
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Funding
- AstraZeneca
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Background: Patients with severe, uncontrolled asthma experience debilitating symptoms that result in meaningful reductions to health-related quality of life. Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody that reduces exacerbations and improves asthma symptoms for patients with severe, uncontrolled eosinophilic asthma. Objective: The objective of this study was to evaluate improvements in daily asthma-related health status outcomes following treatment with benralizumab. Methods: Pooled results from the SIROCCO (NCT01928771) and CALIMA (NCT01914757) Phase III studies were analyzed. Patients aged 12-75 years with severe, uncontrolled asthma, and blood eosinophil counts (BEC) >= 300 and >= 150 cells/mu L were evaluated. Patients received subcutaneous benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W, first three doses Q4W) or placebo and completed a daily diary reporting rescue medication use, night-time awakening requiring rescue medication use, perceived tiredness, and asthma-related activity impairment. Outcome measures were compared across treatment arms from baseline to end of treatment (EOT) using a mixed-effect model for repeated measures analyses. Results: Patients with BEC >= 300 cells/mu L receiving benralizumab Q8W had greater improvements in all patient-reported outcomes at EOT relative to baseline than patients receiving placebo (all nominal P <= 0.013). Effects were reported as early as 3 days following the initial dose and sustained throughout treatment for daily and night-time rescue medication use and night-time awakenings requiring rescue medication. For patients with BEC >= 300 and >= 150 cells/mu L, sustained improvements in activity impairment items (all nominal P<0.05) were achieved with benralizumab Q8W at week 2. Conclusion: Benralizumab produces sustained reductions by as early as 3 days in rescue medication use and activity impairment for patients with severe, uncontrolled eosinophilic asthma.
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