Lung Function in Severe Asthma Improved With Benralizumab

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Peak expiratory flow increases were greater with benralizumab than placebo in patients with severe eosinophilic asthma.

This article is part of Pulmonology Advisor‘s coverage of the American Thoracic Society’s International Conference, taking place in San Diego, California. Our staff will report on medical research related to asthma and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from ATS 2018.

SAN DIEGO — Improved lung function, demonstrated by an increased morning peak expiratory flow, was shown in participants with severe eosinophilic asthma when treated with benralizumab, a monoclonal antibody that targets antileukin-5 receptors to rapidly deplete eosinophils. Additionally, benralizumab significantly reduced the need for oral corticosteroid treatment, which is associated with several adverse side effects. This research was presented at the American Thoracic Society 2018 International Conference in San Diego, California.

Researchers performed a randomized, parallel group, placebo-controlled trial that included 220 participants with severe, uncontrolled asthma (eosinophil counts ≥150 cells/µL) who were treated with high-dose combination corticosteroid and long-acting beta-agonist inhalers. The ZONDA trial (ClinicalTrials.gov Identifier: NCT02075255) participants had a 4-week induction phase that established the minimum effective dose of oral corticosteroid to maintain asthma control, followed by 20 weeks of reducing oral corticosteroid and a 4-week maintenance phase.

The trial cohort received 30 mg benralizumab every 4 weeks, every 8 weeks, or placebo treatments every 4 weeks. The treatment efficacy was evaluated by measuring the morning and evening peak expiratory flow of each participant during the course of the trial (from baseline to week 28). Increases in peak expiratory flow were greatest in the group receiving benralizumab every 8 weeks. The group who received benralizumab every 4 weeks showed a greater increase in peak expiratory flow compared with the placebo group, but a smaller increase than the 8-week group. Specifically by day 28 (end of induction), increases in peak expiratory flow from baseline was 32.23 L/min for patients taking benralizumab every 8 weeks vs 16.89 L/min for placebo (mean difference 15.34 L/min, 95% CI, -6.84 to 37.51; P =.174). 

At the study’s end point, mean changes from baseline in the morning peak expiratory flow were also greater with patients who received benralizumab every 8 weeks vs placebo (38.95 L/min vs 10.44 L/min; mean difference 28.52, 95% CI, 3.50-53.53; P =.026). Njira L. Lugogo, from the University of Michigan Medical Center in Ann Arbor, Michigan, concluded that treatment with benralizumab resulted in clinically meaningful improvement in lung function for these patients “even when the mean daily OCS [oral corticosteroid] dosage wasreduced.”

The authors of the study concluded that the trial results are in support of benralizumab as an oral corticosteroid-sparing therapy that can improve lung function in individuals with uncontrolled eosinophilic asthma.

Disclosures: This trial was designed by AstraZeneca in collaboration with the primary study author.

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Reference

Lugogo N, Kline JN, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Benralizumab improves morning peak expiratory flow while reducing oral corticosteroid dosages for patients with severe, uncontrolled asthma in the ZONDA phase III trial. Presented at: American Thoracic Society 2018 International Conference; May 18-23, 2018; San Diego, CA. Abstract 7712.