Benralizumab Achieves Clinically Meaningful Improvements in Asthma and Nasal Polyposis

The majority of patients with asthma and nasal polyposis (NP) who were treated with benralizumab were considered comprehensive responders, according to the results of a post hoc subanalysis of the phase 3B ANDHI clinical trial (ClinicalTrials.gov Identifier: NCT03170271), presented at the America College of Allergy, Asthma & Immunology (ACAAI) 2020 Annual Scientific Meeting, held virtually from November 13 to 15, 2020. Participants attained clinically meaningful improvement in the Sino-Nasal Outcome Test-22 (SNOT-22) with multiple asthma outcomes, including exacerbations, health-related quality of life, lung function, and asthma control. Comprehensive response was defined as attaining a clinically meaningful improvement in SNOT-22 of -8.9 units, along with clinically meaningful results for 4 additional criteria: (1) asthma exacerbation rate (AER; 0 exacerbations), (2) St. George’s Respiratory Questionnaire (SGRQ; change ≤ -4 units), (3) forced expiratory volume in 1 second (FEV₁; improvement ≥200 mL, and (4) Asthma Control Questionnaire 6 (ACQ-6; change ≤ -0.5).

Investigators sought to evaluate patients’ comprehensive response to benralizumab therapy, based on NP and measures of asthma. Adults with severe eosinophilic asthma were randomly assigned for 24 weeks to treatment with benralizumab or placebo. All individuals who had physician-diagnosed NP at baseline were included in the current subanalysis.

A total of 153 adult patients were randomly assigned to treatment with benralizumab (n=96) or placebo (n=57). Median participant age was 53 years. At baseline, the following values were reported among the participants: median peripheral blood eosinophil count=510 cells/µL; mean prior-year AER=3.3; mean prebronchodilator FEV₁=55% predicted; mean SNOT-22=50.2; mean SGRQ total score=53.1; and mean ACQ-6=2.9.

At week 24, a higher percentage of patients demonstrated clinically meaningful improvements in SNOT-22 with benralizumab compared with placebo (69.8% vs 43.9%, respectively). Additionally, comprehensive responders were more common in the benralizumab group than in the placebo group (42.7% vs 5.3%, respectively). The percentages of comprehensive responders increased among participants who met 3, 2, or 1 additional criteria (up to 53.1% vs 12.3%. 60.4% vs 24.6%, and 64.6% vs 29.8%, with benralizumab vs placebo, respectively).

The investigators concluded that most patients with asthma and NP who were treated with benralizumab were comprehensive responders, having achieved clinically meaningful improvement in SNOT_22 with multiple asthma outcomes (exacerbations, health-related quality of life, lung function, or asthma control).

Reference

Kreindler J, Chanez P, Bourdin A, Burden A, Garcia Gil A. Comprehensive response to benralizumab by patients with nasal polyposis and severe eosinophilic asthma. Presented virtually at: the American College of Allergy, Asthma & Immunology (ACAAI) 2020 Annual Scientific Meeting (Virtual Experience); November 13-15, 2020. Abstract P208.