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Onset of effect, changes in airflow obstruction and lung volume, and health-related quality of life improvements with benralizumab for patients with severe eosinophilic asthma: Phase IIIb randomized, controlled trial (SOLANA)

Journal of Asthma and Allergy Feb 24, 2020

Panettieri RA, Welte T, Shenoy KV, et al. - Researchers intended to physiologically define benralizumab’s onset of effect as well as maintenance of that effect for patients suffering from severe eosinophilic asthma, in a multicenter, randomized, double-blind, parallel-group, placebo-controlled, Phase IIIb study, named the SOLANA trial. This investigation was performed at 49 centers in six countries (Chile, Germany, Hungary, the Philippines, South Korea, and the United States). Randomization of eligible patients exhibiting baseline blood eosinophil counts ≥ 300 cells/μL to receive subcutaneous benralizumab (30 mg) or placebo at Days 0, 28, and 56 was done. The average shift from baseline in prebronchodilator forced expiratory volume in 1 s (pre-BD FEV1) during the Day 28–Day 84 period for benralizumab vs placebo was considered as the primary endpoint. They found benralizumab 30 mg vs placebo did not afford statistically significant improvement from baseline in pre-BD FEV1. Early (Day 7) nonstatistically significant improvements in whole-body plethysmography evaluations of hyperinflation and clinically meaningful improvements in patient-reported outcome (PRO) measures (Asthma Control Questionnaire 6 at Day 14 and St. George’s Respiratory Questionnaire at Day 28) were evident with benralizumab vs placebo, and these effects were maintained over the treatment duration. The documented early alterations in lung volume despite relatively small improvements in airflow obstruction indicate that benralizumab’s anti-inflammatory effect likely be manifested as deflation over time for patients exhibiting hyperinflation, who potentially have a greater degree of airway remodeling. The rapid PRO improvements noted for certain patients could be explained, in part, by this early effect.
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