Chest
Volume 159, Issue 2, February 2021, Pages 496-506
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Asthma: Original Research
Real-World Effectiveness of Benralizumab in Severe Eosinophilic Asthma

Some of these data were presented previously in abstract form (Kavanagh J, Roxas C, Thomson L, Fernandes M, Green L, d’Ancona G, et al. Thorax. 2019;74(Suppl 2):A138).
https://doi.org/10.1016/j.chest.2020.08.2083Get rights and content

Background

Benralizumab is an IL5-receptor monoclonal antibody licensed for the treatment of severe eosinophilic asthma (SEA). It has demonstrated efficacy in clinical trials in reducing asthma exacerbation rates and maintenance oral corticosteroids (mOCSs).

Research Question

What is the real-world effectiveness of benralizumab and what baseline characteristics are associated with response to therapy?

Study Design and Methods

We assessed outcomes in all SEA patients who began benralizumab treatment at our specialist center. At each dosing visit, exacerbation history, mOCS dose, spirometry, and Asthma Control Questionnaire (ACQ6) and Mini-Asthma Quality of Life Questionnaire (mAQLQ) scores were recorded. Response to treatment was defined as a reduction of ≥ 50% in annualized exacerbation rate (AER) or in mOCS dose after 48 weeks of treatment. Super response was defined as zero exacerbations and no mOCSs for asthma.

Results

One hundred thirty patients were included in the analysis. At 48 weeks, a 72.8% reduction in AER was noted, from 4.92 ± 3.35 per year in the year preceding biologic treatment to 1.34 ± 1.71 per year (P < .001), including 57 patients (43.8%) who were exacerbation-free with benralizumab. In those receiving mOCSs (n = 74 [56.9%]), the median daily prednisolone dose fell from 10 mg (interquartile range, 5-20 mg) to 0 mg (interquartile range, 0-5 mg; P < .001), and 38 of 74 patients (51.4%) were able to discontinue mOCS therapy. Clinically and statistically significant improvements were found in ACQ6 scores, mAQLQ scores, and FEV1. Overall, 51 patients (39%) met the super responder definition and 112 patients (86%) met the responder definition. The optimal regression model of super responders vs other responders included baseline characteristics associated with a strongly eosinophilic phenotype and less severe disease. Eighteen patients (13.8%) were nonresponders to benralizumab. Evidence of chronic airway infection was observed in 6 of 18 patients, and an increase in the blood eosinophil count consistent with the development of anti-drug antibodies was observed in 5 of 18 patients.

Interpretation

In a large real-world SEA cohort, benralizumab led to significant improvements in all clinical outcome measures. A lack of response was seen in a minority of patients and should be a focus for future investigation.

Section snippets

Study Design and Approval

We performed a retrospective analysis of all patients with SEA who commenced treatment with benralizumab between May 2018 and April 2019 at our tertiary referral asthma center in the United Kingdom. Ethical approval was gained from the London—Bloomsbury Research Ethics Committee (Identifier: 15/LO/0886).

Study Participants

All patients were reviewed by an asthma physician, fulfilled the ERS/ATS definition of severe asthma,15 and had confirmed adherence to background therapy (via ICS or long-acting β2 agonist

Results

A total of 136 patients began benralizumab therapy, with 6 patients excluded from the analysis because they stopped treatment before 24 weeks: 3 did not complete clinic follow-up; 2 stopped because of presumed medication-related adverse events; and 1 stopped because of pregnancy. A further 7 patients stopped between 24 and 48 weeks because of suboptimal response; these patients were included in the analysis. The baseline characteristics of the included patients (n = 130) reflected those of

Discussion

We report real-world experience of using the anti-IL5-receptor monoclonal antibody benralizumab in a large cohort of patients with SEA. We observed that benralizumab leads to clinically and statistically significant reductions in asthma exacerbations, with more than 40% of patients remaining exacerbation-free at 1 year. This was achieved despite a median reduction in mOCS dose of 100%, with 70% of patients able to stop mOCS therapy for asthma. Marked improvements in the patient-reported outcome

Acknowledgments

Author contributions: J. E. K. takes responsibility for the integrity of the data and analysis. G. d’A., C. R., M. F., L. G., and L. T. contributed to data collection. J. E. F., A. P. H., A. D., J. D., A. M. N., B. D. K., and D. J. J. contributed to the study design, data analysis and interpretation, and the writing of the manuscript.

Financial/nonfinancial disclosures: The authors have reported to CHEST the following: D. J., B. K., and G. d'A. report advisory board and speaker fees and congress

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FUNDING/SUPPORT: The authors have reported to CHEST that no funding was received for this study.

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