Benralizumab beneficial to Asians with severe eosinophilic asthma

The efficacy of benralizumab against severe eosinophilic asthma has been confirmed in an Asian population, with results consistent with the global data, as shown in the phase III MIRACLE trial.

MIRACLE was conducted in China, South Korea, and the Philippines. The study population comprised 695 patients with severe asthma who were between 12 and 75 years of age and receiving inhaled corticosteroid/long-acting β₂-agonists at medium to high doses.

The patients were randomly assigned to receive treatment with either benralizumab 30 mg or placebo. Annual asthma exacerbation rate was the primary endpoint. Secondary endpoints included change from baseline at week 48 in pre-bronchodilator (BD) forced expiratory volume in 1 second (pre-BD FEV₁) and total asthma symptom score (TASS). Safety at ≤week 56 was also assessed. The analyses were stratified by baseline blood eosinophil count (bEOS: ≥300/μL and <300/μL).

Of the patients, 473 had baseline bEOS ≥300/μL (benralizumab, n=236; placebo n=237) and 222 had baseline bEOS <300/μL.

In the bEOS ≥300/μL cohort, benralizumab was associated with a 74-percent lower annual asthma exacerbation rate compared with placebo (rate ratio, 0.26, 95 percent confidence interval [CI], 0.19–0.36; p<0.0001). Patients on benralizumab also showed significant improvements in pre-BD FEV₁ (least squares difference [LSD], 0.25 L, 95 percent CI, 0.17–0.34; p<0.0001) and total asthma symptom score (LSD, −0.25, 95 percent CI, −0.45 to −0.05; p=0.0126).

In the bEOS <300/μL cohort, treatment with benralizumab yielded only numerical improvements in annual asthma exacerbation rate, pre-BD FEV₁, and total asthma symptom score compared with placebo.

In terms of safety, there was no significant between-group difference in the frequency of adverse events in the overall population: 76 percent with benralizumab and 80 percent with placebo.