The following article was published on NEJM.org to coincide with the #AAAAI2024 Annual Meeting
Michael E. Wechsler, M.D., M.M.Sc., Parameswaran Nair, M.D., Ph.D., Benjamin Terrier, M.D., Ph.D., Bastian Walz, M.D., Arnaud Bourdin, M.D., Ph.D., David R.W. Jayne, M.D., David J. Jackson, F.R.C.P., Ph.D., Florence Roufosse, M.D., Ph.D., Lena Börjesson Sjö, Ph.D., Ying Fan, Ph.D., Maria Jison, M.D., Christopher McCrae, Ph.D., et al., for the MANDARA Study Group* NEJM February 23, 2024 DOI: 10.1056/NEJMoa2311155
Abstract
BACKGROUND
Eosinophilic granulomatosis with polyangiitis (EGPA) is a vasculitis characterized by eosinophilic inflammation. Benralizumab, a monoclonal antibody against the interleukin-5α receptor expressed on eosinophils, may be an option for treating EGPA.
METHODS
We conducted a multicenter, double-blind, phase 3, randomized, active-controlled noninferiority trial to evaluate the efficacy and safety of benralizumab as compared with mepolizumab. Adults with relapsing or refractory EGPA who were receiving standard care were randomly assigned in a 1:1 ratio to receive benralizumab (30 mg) or mepolizumab (300 mg) subcutaneously every 4 weeks for 52 weeks. The primary end point was remission at weeks 36 and 48 (prespecified noninferiority margin, –25 percentage points). Secondary end points included the accrued duration of remission, time to first relapse, oral glucocorticoid use, eosinophil count, and safety.
RESULTS
A total of 140 patients underwent randomization (70 assigned to each group). The adjusted percentage of patients with remission at weeks 36 and 48 was 59% in the benralizumab group and 56% in the mepolizumab group (difference, 3 percentage points; 95% confidence interval [CI], –13 to 18; P=0.73 for superiority), showing noninferiority but not superiority of benralizumab to mepolizumab. The accrued duration of remission and the time to first relapse were similar in the two groups. Complete withdrawal of oral glucocorticoids during weeks 48 through 52 was achieved in 41% of the patients who received benralizumab and 26% of those who received mepolizumab. The mean (±SD) blood eosinophil count at baseline was 306.0±225.0 per microliter in the benralizumab group and 384.9±563.6 per microliter in the mepolizumab group, decreasing to 32.4±40.8 and 71.8±54.4 per microliter, respectively, at week 52. Adverse events were reported in 90% of the patients in the benralizumab group and 96% of those in the mepolizumab group; serious adverse events were reported in 6% and 13%, respectively.
CONCLUSIONS
Benralizumab was noninferior to mepolizumab for the induction of remission in patients with relapsing or refractory EGPA. (Funded by AstraZeneca; MANDARA ClinicalTrials.gov number, NCT04157348. opens in new tab.)
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