Benralizumab reduces asthma exacerbations in Asians

Treatment with benralizumab significantly reduces the annual asthma exacerbation rate (AAER) among Asian patients with severe uncontrolled asthma compared with placebo, according to a subgroup analysis of the MIRACLE trial presented at ERS 2023.

This analysis involved 473 Asian patients (mean age 51.4 years, 61.3 percent female) with severe uncontrolled asthma who had a baseline blood eosinophil count (bEOS) of ≥300/µL. Participants were randomized in a 1:1 ratio to receive either subcutaneous benralizumab 30 mg (n=236) or placebo (n=237) for 48 weeks. The dosing for benralizumab was every 4 weeks for the first three doses and every 8 weeks thereafter.

By week 48, the AAER was significantly reduced by 74 percent among patients treated with benralizumab compared with placebo (0.49 vs 1.88; rate ratio, 0.26; p<0.0001). [ERS 2023, abstract PA4130]

Similarly, a significant improvement in lung function, as measured by prebronchodilator FEV₁*, from baseline to week 48 was observed with benralizumab vs placebo (0.33 vs 0.10 L; least square [LS] mean difference, 0.25; p<0.0001).

Benralizumab also significantly improved asthma symptoms, as shown by a greater decrease in Total Asthma Symptom Score (-1.07 vs -0.80; LS mean difference, -0.25; p=0.0126), and health-related quality of life (HRQoL) measured using SGRQ** total score (-23.24 vs -14.75; LS mean difference, -9.19; p_nominal<0.0001) compared with placebo at week 48.

In addition, significantly more benralizumab-treated patients achieved an improvement of ≥4 units in the SGRQ total score after 48 weeks than the placebo-treated patients (73.3 percent vs 58.6 percent; odds ratio, 2.24; p_nominal=0.0001).

The rates of adverse events were similar between the benralizumab and placebo arms (74.4 percent vs 77.8 percent), with no deaths reported in either treatment arm.

There were also no new safety signals identified.

“Overall, benralizumab treatment resulted in significantly reduced AAER and improved lung function, asthma symptoms, and HRQoL in Asian patients with severe eosinophilic asthma, [particularly in a subgroup of patients with baseline bEOS ≥300/µL],” said the researchers. “These results were consistent with the known global profile.”

“These findings reinforce the efficacy and safety profile of benralizumab for asthma and support its use in patients from Asia, particularly China,” they noted.