Benralizumab noninferior to mepolizumab for eosinophilic granulomatosis with polyangiitis

1. In this randomized controlled trial, benralizumab was noninferior for beginning remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA) compared to mepolizumab.

2. Adverse events occurred in 90% and 96% of patients in the benralizumab and mepolizumab groups, respectively.

Evidence Rating Level: 1 (Excellent)

Study Rundown: EGPA is an inflammatory disorder with patients experiencing clinical features such as asthma, extravascular granulomas, and blood and tissue eosinophilia. The treatment for this rare disease has been glucocorticoids and immunosuppressants despite the adverse side effects it elicits. Mepolizumab is a monoclonal antibody that binds to interleukin-5 to inhibit eosinophil activation and has shown positive effects in reducing remission time. Benralizumab is a fucosylated monoclonal antibody that leads to eosinophil apoptosis and has a high affinity for the human interleukin-5 receptor ⍺ subunit. A randomized, double-blind study assigned participants to receive 300 mg subcutaneous mepolizumab through three injections or 30 mg benralizumab through one injection in a 1:1 ratio. EGPA showed noninferiority of benralizumab to mepolizumab in remission induction. Since the disease of interest is so rare, the study was limited by a small sample size, thus making conclusions difficult to arrive at. Overall, at weeks 36 and 48, benralizumab was noninferior to mepolizumab for remission induction in patients with EGPA.

Click to read the study in NEJM

In-Depth [randomized controlled trial]: The study included 140 randomized participants equally into the two different groups, with the demographics being equally balanced between the groups; 60% were women, and the mean age was 52.3±14.1 years. To be eligible to participate in the study, patients had to be age 18 or older, have an EGPA diagnosis, and have two features of EGPA and relapsing disease despite previous oral glucocorticoid therapy. Patients were excluded if they had a life-threatening EGPA within the three months before their first visit. At weeks 36 and 48, the percentage of patients that were in remission in the benralizumab and mepolizumab groups was 59% and 56%, respectively (difference, three percentage points; 95% confidence interval [CI], -13 to 18; p=0.73 for superiority) meaning that there was noninferiority of benralizumab to mepolizumab. The number of patients in remission at weeks 36 and 48 was 79% in the benralizumab group and 74% in the mepolizumab group. (difference, 5 percentage points; 95% CI, -7 to 18). Both groups had 30% of patients experience a relapse, with the time being similar in both groups (hazard ratio, 0.98; 95% CI, 0.53 to 1.82). In patients that received benralizumab, complete glucocorticoid withdrawal was achieved in 41% of patients, whereas in patients receiving mepolizumab, only 26% experienced complete withdrawal. At baseline, the mean (±SD) blood eosinophil count was 306.0±225.0 per microliter and 384.9±563.6 per microliter in the benralizumab and mepolizumab respectively. Adverse events were reported in 90% of the benralizumab patients and 96% of the mepolizumab patients, with only 6% and 13% of serious adverse events reported, respectively. In all, benralizumab was noninferior to mepolizumab.

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