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Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort.

ABSTRACT: Background and objective:Benralizumab (Fasenra™) has recently been approved as add-on maintenance treatment for adult patients with severe eosinophilic asthma inadequately controlled despite high-dosage inhaled corticosteroids plus long-acting ?2-agonists. We aimed to identify and describe the clinical characteristics and disease burden of patients with severe, uncontrolled, eosinophilic asthma in France who may be eligible for treatment with benralizumab. Patients and methods:This was a retrospective analysis of a prospective, noninterventional, observational study of patients in France enrolled in the Asthma and Bronchial Obstruction Cohort (COBRA). First, we selected adult patients with severe asthma, a documented blood eosinophil count, 12 months of baseline data, and 12 months of follow-up data. Of these study-eligible patients, we next determined the prevalence and described the clinical characteristics and disease burden of patients who would be eligible to receive benralizumab, namely those with ?2 asthma exacerbations in the previous 12 months and a blood eosinophil count ?300/?L who were receiving high-dosage inhaled corticosteroids/long-acting ?2-agonists. Results:Of the 441 patients eligible for this study, 85 (19%) met the criteria for benralizumab therapy. At study inclusion, benralizumab-eligible patients had a smaller prebronchodilator forced expiratory volume in 1 second and less effective asthma control compared with benralizumab-ineligible patients. During the 12-month follow-up period, benralizumab-eligible patients had greater frequencies of asthma exacerbations and hospitalizations compared with benralizumab-ineligible patients. Conclusion:Of patients with severe asthma, approximately 20% were qualified for benralizumab treatment. Benralizumab-eligible patients had increased bronchial obstruction, worse asthma control, and a greater frequency of asthma exacerbations and hospitalizations during follow-up care compared with benralizumab-ineligible patients, demonstrating inadequate disease control for these patients.

SUBMITTER: Aubier M

PROVIDER: S-EPMC6124449 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort.

Aubier Michel M Thabut Gabriel G Fabry-Vendrand Caroline C

Journal of asthma and allergy 20180831

<h4>Background and objective</h4>Benralizumab (Fasenra<sup>™</sup>) has recently been approved as add-on maintenance treatment for adult patients with severe eosinophilic asthma inadequately controlled despite high-dosage inhaled corticosteroids plus long-acting β<sub>2</sub>-agonists. We aimed to identify and describe the clinical characteristics and disease burden of patients with severe, uncontrolled, eosinophilic asthma in France who may be eligible for treatment with benralizumab.<h4>Patien ...[more]

PMID: 30214249

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Project description:PurposeIn the Phase III SIROCCO trial (NCT01928771), benralizumab significantly reduced asthma exacerbations and improved lung function and symptoms for patients with severe, uncontrolled eosinophilic asthma. The aim of this subgroup analysis was to evaluate efficacy and safety of benralizumab for Korean patients in SIROCCO.MethodsSIROCCO was a randomized, double-blind, parallel-group, placebo-controlled trial of 1,204 patients aged 12-75 years with severe asthma uncontrolled by high-dosage inhaled corticosteroids/long-acting β₂-agonists (ICS/LABA). Patients received benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W; first 3 doses Q4W) or placebo Q4W for 48 weeks. The primary analysis population comprised patients with blood eosinophil counts ≥ 300 cells/μL. This subgroup analysis evaluated Korean patients from this group.ResultsOf 122 Korean patients randomized, 86 had blood eosinophil counts ≥ 300 cells/μL. Benralizumab reduced the annual asthma exacerbation rate by 70% (Q4W: rate estimate 0.79, rate ratio 0.30 [95% confidence interval {CI}, 0.13-0.65], nominal P = 0.003; n = 28) and 85% (Q8W: rate estimate 0.40, rate ratio 0.15 [95% CI, 0.06-0.36], nominal P < 0.001; n = 30) vs. placebo (rate estimate 2.67, n = 28). Prebronchodilator forced expiratory volume in 1 second was increased with benralizumab treatment by 0.270 L (Q4W: 95% CI, 0.039-0.500, nominal P = 0.023; n = 28) and 0.362 L (Q8W: 95% CI, 0.143-0.582, nominal P = 0.002; n = 30) vs. placebo (n = 27). Total asthma symptom score was similar for patients receiving either benralizumab Q4W (-0.27 [95% CI, -0.83 to 0.30], nominal P = 0.356; n = 27) or benralizumab Q8W (0.10 [95% CI, -0.44 to 0.65], nominal P = 0.708; n = 30) vs. placebo (n = 28). Drug-related adverse events were experienced by 2%, 8%, and 5% of patients in the placebo, benralizumab Q4W, and benralizumab Q8W arms.ConclusionsBenralizumab reduced annual asthma exacerbation rates, increased lung function, and was well-tolerated by Korean patients with severe, uncontrolled eosinophilic asthma.

Project description:BackgroundPatients 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.ObjectiveThe objective of this study was to evaluate improvements in daily asthma-related health status outcomes following treatment with benralizumab.MethodsPooled 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.ResultsPatients 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.ConclusionBenralizumab 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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Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort.

Publications

Characteristics of patients with severe, uncontrolled, eosinophilic asthma enrolled in a French cohort.

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