Benralizumab Associated with Fewer Exacerbations in Severe Asthma with Eosinophilia

By Kelly Young

Edited by David G. Fairchild, MD, MPH

Benralizumab, an anti-interleukin-5 pathway monoclonal antibody, is associated with 28% to 51% fewer exacerbations of severe eosinophilic asthma, according to two industry-conducted, phase III studies presented at the European Respiratory Society meeting and published in the Lancet.

In the SIROCCO trial, 1200 patients with asthma who were taking inhaled corticosteroids and long-acting beta2-agonists were randomized to receive add-on subcutaneous benralizumab (every 4 or 8 weeks) or placebo. Among patients with baseline blood eosinophil counts at or above 300 cells per µL, benralizumab was associated with significantly reduced annual asthma exacerbations relative to placebo (rate ratio for dosing every 4 weeks, 0.55; RR for dosing for every 8 weeks, 0.49).

In the CALIMA trial, 1300 patients were randomized to add-on benralizumab or placebo. After 56 weeks, the rate ratios were 0.64 for dosing every 4 weeks and 0.72 for dosing every 8 weeks among patients with eosinophilia.

In both trials, adverse event rates were similar between benralizumab and placebo, and benralizumab quickly depleted blood eosinophil levels.

NEJM Journal Watch General Medicine’s David Amrol comments: “Patients best suited for anti-IL-5 drugs are those with severe uncontrolled asthma with greater than 300 peripheral eosinophils/µL and three or more exacerbations in the previous year despite high-dose inhaled steroids and long acting bronchodilators. However, they currently come with an over $30,000 per year price tag which would hopefully be reduced if benralizumab could be dosed every 8 rather than 4 weeks.”