Recently, the results of the MIRACLE Phase III trial were published in the Respiratory Medicine journal. The study revealed that among patients with severe eosinophilic asthma (SEA) in several Asian countries, including China, who had not achieved control with standard therapy, treatment with benralizumab significantly reduced the annual acute exacerbation rate (AAER) by 74% within 48 weeks compared to placebo, with both statistical and clinical significance.
Data indicates that in China, approximately 8%-10% of asthma patients (totaling around 46 million individuals) suffer from severe asthma, with a striking 76.8% of them having severe eosinophilic asthma. However, a considerable number of asthma patients in China remain undiagnosed and inadequately treated.
"The results of the MIRACLE trial confirm that for Chinese patients with severe eosinophilic asthma, anti-IL-5 receptor monoclonal antibody (benralizumab) can rapidly and durably control asthma symptoms, significantly reducing the annual acute exacerbation rate. Importantly, the study also demonstrates the significant efficacy of benralizumab in asthma patients with inadequate control on medium-dose ICS/LABA," stated Professor Zhong Nanshan, the international coordinating investigator of the MIRACLE study.
Professor Lai Kefang, the national principal investigator of the MIRACLE trial and chairman of the Chinese Cough Alliance, remarked that severe eosinophilic asthma is a debilitating condition severely impacting the quality of life. In China, many patients continue to experience uncontrolled symptoms despite using medium to high doses of inhaled therapy, leading to frequent exacerbations, worsening symptoms, and declining lung function. The results of the Chinese MIRACLE trial are encouraging, confirming the clinical efficacy of anti-IL-5 receptor monoclonal antibody (benralizumab) in inadequately controlled severe eosinophilic asthma patients.
Benralizumab is a monoclonal antibody that directly binds to IL-5Rα on eosinophils, attracting NK cells and inducing apoptosis, resulting in rapid depletion of eosinophils. It is currently approved in over 80 countries and regions worldwide. The MIRACLE III trial enrolled 695 Asian (predominantly Chinese) patients aged 12 to 75 years with uncontrolled severe eosinophilic asthma and compared the efficacy and safety of benralizumab treatment with placebo.
The MIRACLE study was a randomized, double-blind, placebo-controlled clinical trial involving patients with asthma who did not achieve effective control with medium to high doses of inhaled corticosteroids combined with long-acting β2-agonists (ICS-LABA) therapy. The trial included 695 Asian (mainly Chinese) patients aged 12 to 75 years, who were randomly assigned in a 1:1 ratio to receive either 30 mg of benralizumab or placebo every four weeks for the first three doses, followed by every eight weeks thereafter for a treatment period of 48 weeks.
