For 10-20% of chronic obstructive pulmonary disease (COPD) patients, a certain type of specialized immune cells called eosinophils produce eosinophilic airway inflammation and lead to acute exacerbations of COPD. A new clinical study from MedImmune and AstraZeneca, with results detailed in the article, “Benralizumab for COPD and Sputum Eosinophilia: A Randomised, Double-blind, Placebo-controlled, Phase 2a Study” published in the Lancet, suggests the agent MEDI-563, otherwise known as benralizumab, may have some effect — albeit a marginal one — on attenuating eosinophilia.
Although there was no statistical significance between treatment with benralizumab and treatment with placebo in terms of acute exacerbation rate, there were numerical improvements in exacerbation rate, forced expiratory volume in one second (FEV1), and self-evaluated disease state.
To be eligible for the study, patients needed to be between the ages of 40 and 85 years, have moderate-to-severe COPD and eosinophilia, and one documented instance of an acute exacerbation from COPD. A total of 101 patients were studied, with 51 treated with benralizumab and 50 treated with placebo. Eight doses of treatment were administered subcutaneously, with 28 days between the first three doses and 56 days between the next five doses.
Annual acute exacerbation rate at the end of the study was 0.95 for benralizumab-treated patients and 0.92 for placebo-treated patients. FEV1 showed an insignificant improvement in benralizumab patients, who gained 0.13 L of expiratory volume, while placebo showed no effect on patients, who lost 0.06 L during the course of the study. When the results of the Saint George’s Respiratory Questionnaire and the Chronic Respiratory Questionnaire self-administered standardised format were considered, there was a marginal improvement among benralizumab patients.
Adverse events were similar among patients, with the majority of events respiratory-related. Serious treatment-emergent adverse events were more common in benralizumab patients, but none was considered to be related to treatment. Overall, although benralizumab is safe for patients, it may not be as effective at treating patients with COPD and eosinophilitis as it was for preclinical studies in the laboratory. The authors of the study state further investigation is warranted based on pre-specified subgroup analysis.