Study Identifies Benralizumab Responders Among COBRA Participants With Severe Asthma

September 12, 2018

A retrospective analysis of data from patients with severe asthma who participated in the COBRA trial identified key clinical characteristics that may help clinicians recognize patients who may benefit from additional targeted drug therapy, such as benralizumab.

A retrospective analysis in patients with severe asthma helped identify key clinical characteristics that may help clinicians recognize patients who may benefit from additional targeted drug therapy, such as benralizumab.

Patients with severe asthma, inadequately controlled by high-dosage inhaled corticosteroids (ICS) plus long-acting β2 agonists (LABA), have increased asthma symptoms, exacerbations, and hospitalizations, lowering their quality of life. When conventional treatments are ineffective, add-on therapies such as targeted therapeutics may be effective in cases of high blood eosinophil counts. Benralizumab is a IL-5 monoclonal antibody that depletes eosinophils through antibody-dependent cell-mediated cytotoxicity.

In previous phase 3 trials, SIROCCO and CALIMA, benralizumab combined with high-dose ICS/LABA significantly reduced exacerbation rates and improved lung function in patients with severe, uncontrolled asthma and high eosinophil counts. The purpose of a study conducted in France by Aubier et al was to analyze the clinical characteristics and disease burden in these patients with severe, uncontrolled asthma eligible for benralizumab treatment and compare it with the patients who are ineligible for treatment.

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The researchers conducted a retrospective analysis of results gathered from the COBRA trial; patients were included if they had severe asthma, high blood eosinophil counts, and 12 months of follow-up data. Patients were classified as being eligible to receive benralizumab if they were on high-dose ICS/LABA, had at least 2 asthma exacerbations in the year prior to data extraction, and a blood eosinophil count ≥300 cells/µL.

Only about 20% of the COBRA study population met this criteria of being eligible to receive benralizumab. Patients eligible for benralizumab at baseline had less effective asthma control (P <.001) and had a higher number of asthma exacerbations in the previous 12 months (P <.001) than patients not eligible for benralizumab. Additional drug use, including ICS/LABA/long-acting muscarinic antagonists (LAMA; 21% vs 12%; P = .03), antileukotriene agents (47% vs 31%; P = .01), LAMA (21% vs 13%; P = .06), and oral corticosteroids (27% vs 19%; P = .13) were all greater in patients who were eligible for benralizumab treatment compared with patients who were not eligible.

After a 12-month follow-up period, patients who were eligible to receive benralizumab had greater mean incidences of asthma exacerbations (3.9/year vs 2.2/year; P <.001), and asthma-related hospitalizations (0.19/year vs 0.09/year; P = .02) compared with patients who were not eligible for benralizumab. In addition, the percentage of patients who were eligible for treatment visited the emergency department more often than patients who were ineligible for treatment (40% vs 25%; P = .03).

A better understanding of the clinical characteristics of patients who are eligible for benralizumab can help clinicians better identify positive responders among patients with severe asthma and eosinophilia.

Reference

Aubier M, Thabut G, Fabry-Vendrant C. Characteristics of patients with severe uncontrolled eosinophilic asthma enrolled in a French cohort. J Asthma Allergy. 2018;11:217-224. doi: 10.2147/JAA.S170866.