Daily patient-reported health status assessment improvements with benralizumab for patients with severe, uncontrolled eosinophilic asthma

Abstract

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/µL 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/µL 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/ µL, 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.

Keywords:

• asthma
• benralizumab
• eosinophils
• interleukin-5 receptor
• monoclonal antibody
• patient-reported outcomes

Data availability

Registry URL and database number: SIROCCO trial: NCT01928771 (URL: https://clinicaltrials.gov/ct2/show/NCT01928771)

CALIMA trial: NCT01914757 (URL: https://clinicaltrials.gov/ct2/show/NCT01914757)

Acknowledgments

Funding for this study was provided by AstraZeneca. Writing and editing support, including preparation of the draft manuscript under the direction and guidance of the authors, incorporating author feedback, and manuscript submission, was provided by Alan Saltzman, PhD, of JK Associates, Inc. (Conshohocken, PA, USA), and Michael A Nissen, ELS, of AstraZeneca (Gaithersburg, MD, USA). This support was funded by AstraZeneca.

Author contributions

Sean O’Quinn, Xiao Xu, and Ian Hirsch were involved in the conception and design, data acquisition, analysis, and interpretation for the study. All authors participated in the preparation of the manuscript and gave final approval of the version of the manuscript for publication. All authors agreed to be accountable for all aspects of the work.

Disclosure

Sean O’Quinn, Xiao Xu, and Ian Hirsch are employees of AstraZeneca.