Researchers conducted the randomized, active-controlled, parallel-group, 52-week, double-blind MANDARA trial (ClinicalTrials.gov Identifier: NCT04157348). They reported on the safety and efficacy profiles of benralizumab and mepolizumab for the treatment of patients with EGPA.

During the 52-week study duration, patients were administered either 30 mg monthly benralizumab or a 3-times-monthly dose of 100 mg mepolizumab through subcutaneous injections. Oral glucocorticoid dosage was reduced to a maximum of 4 mg per day if disease progression was under control.

The primary endpoint was defined as the percentage of patients achieving remission (Birmingham Vasculitis Activity Score = 0; OGC dose ≤4 mg/day) at weeks 36 and 48. 

Secondary endpoints encompassed evaluating sustained remission, OGC usage, clinical improvements, time to the first relapse, and safety monitoring. A total of 140 patients were included in the analysis and randomly assigned to the benralizumab (n=70) and mepolizumab (n=70) groups. The mean patient age was 52.3 years and 60% were women.

At both weeks 36 and 48, the benralizumab group exhibited an adjusted remission rate of 59.2%, while the mepolizumab group demonstrated a rate of 56.5% (difference, 2.71%; 95% CI, -12.54 to 17.96; P =.7278), thereby validating the noninferiority of benralizumab.

Both groups experienced a relapse rate of 30%. At baseline, the average OGC dose was 11.02±5.25 mg per day. By weeks 48 to 52, 86.1% of the benralizumab group had successfully reduced their OGC dose by at least 50% from baseline, with an additional 41.4% completely tapering off OGCs. 

Adverse events (AEs) were reported by 90% of patients treated with benralizumab and 95.7% of those treated with mepolizumab. The most commonly observed AEs included COVID-19 (21.4% vs 27.1%), headache (17.1% vs 15.7%), and arthralgia (17.1% vs 11.4%) among the benralizumab vs mepolizumab groups, respectively. 

Serious AEs occurred among 5.7% of patients taking benralizumab and 12.9% of patients taking mepolizumab. The study authors noted, “No benralizumab and 2 mepolizumab recipients experienced AEs leading to discontinuation of treatment.”

Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.