Benefits of CMAB007 in Chinese Patients Having Inadequately Controlled Moderate/Severe Asthma With Increased Total IgE: A Randomized Phase 3 Trial

PURPOSE: The objective of this trial was to evaluate the efficacy and safety of anti-IgE monoclonal antibody (CMAB007) in Chinese patients with inadequately controlled moderate or severe asthma with increased total IgE level despite medium or high dose inhaled corticosteroids (ICS)/long acting β₂-agonist (LABA) treatment. METHODS: This was a multicenter, randomized, placebo controlled, double blinded, phase 3 trial. Eligible patients with moderate or severe asthma with increased total IgE level (60-1,500 IU/mL) receiving optimal ICS-LABA were randomly assigned to receive CMAB007 or placebo treatment at a 2:1 ratio for 24 weeks. The primary efficacy endpoint was asthma exacerbation (AE) rate, the key second endpoints were asthma control test (ACT) score, pulmonary function and safety. RESULTS: = 0.002). The incidence of adverse events was similar between the CMAB007 (77.2%) and placebo groups (75.2%). CONCLUSIONS: CMAB007 reduces AE and improves asthma control, lung function and quality of life without additional safety concern in Chinese patients having moderate to severe asthma with increased total IgE level. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03468790.