Benralizumab non-inferior to mepolizumab for eosinophilic granulomatosis with polyangiitis
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Key takeaways:
- The safety of benralizumab showed no “meaningful difference” compared with mepolizumab.
- Benralizumab only requires one monthly injection, while mepolizumab requires three.
Benralizumab is noninferior to mepolizumab in achieving remission of relapsing or refractory eosinophilic granulomatosis with polyangiitis at 36 and 48 weeks, according to data published in The New England Journal of Medicine.
“This is great news for patients with eosinophilic granulomatosis with polyangiitis,” Michael E. Wechsler, MD, MMSc, of National Jewish Health, in Denver, told Healio. “The future is bright.”
The FDA approved mepolizumab (Nucala, GlaxoSmithKline), a monoclonal antibody targeting interleukin (IL)-5, to treat eosinophilic granulomatosis with polyangiitis (EGPA) in 2017. According to Wechsler, lead author of the study, it was “a logical choice” to also investigate benralizumab (Fasenra, AstraZeneca), an anti-IL-5 receptor antagonist, in patients with the disease.
To compare the efficacy and safety of benralizumab vs. mepolizumab, Wechsler and colleagues conducted a phase 3, double-blind, randomized, active-controlled noninferiority trial across 50 sites in nine countries. Participants were randomly assigned to receive one of two treatments every 4 weeks for 52 weeks — a single injection of benralizumab 30 mg or three injections of mepolizumab 100 mg.
The primary endpoint was remission at weeks 36 and 48, defined as a Birmingham Vasculitis Activity Score of zero and an oral glucocorticoid dosage of 4 mg per day or less. Marginal standardization was used to generate confidence intervals adjusted for treatment group, region, baseline oral glucocorticoid dose and baseline Birmingham Vasculitis Activity Score.
The study included 140 adults, split evenly between benralizumab and mepolizumab groups. To be eligible, participants had to have an EGPA diagnosis in their medical history, or asthma and blood eosinophilia with at least two other features of EGPA, and non-response to oral glucocorticoids.
According to the researchers, benralizumab demonstrated “noninferiority, but not superiority” to mepolizumab, with an adjusted 59% of patients treated with benralizumab achieving remission at weeks 36 and 48, vs. 56% in the mepolizumab group (difference = 3 percentage points; 95% CI, –13 to 18). In addition, the treatment groups had similar duration of remission and time to first relapse. Among those treated with benralizumab, 41% achieved complete withdrawal of oral glucocorticoids from weeks 48 through 52, compared with 26% of those receiving mepolizumab.
Adverse events were reported by 90% of patients in the benralizumab group and 96% of patients in the mepolizumab group, with the most common being COVID-19, headache and arthralgia. Serious adverse events were reported by 6% of patients treated with benralizumab and 13% of those treated with mepolizumab, with the most common being COVID-19 in 1% of each group and prostate cancer in 3% of the mepolizumab group.
“This study gives patients and providers data supporting an additional choice for EGPA,” Wechsler said. “Benralizumab is another effective option and only requires one monthly injection.”
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