Pneumologie 2019; 73(S 01)
DOI: 10.1055/s-0039-1678229
Posterbegehung (P18) – Sektion Klinische Pneumologie
Klinische Studien bei COPD, Asthma, Palliativmedizin & more
Georg Thieme Verlag KG Stuttgart · New York

Demographics, Clinical Characteristics, and Response to Benralizumab Treatment for Patients with Severe, Eosinophilic Asthma and Fixed Airflow Obstruction

JG Zangrilli
1   Astrazeneca
,
BE Chipps
2   Capital Allergy and Respiratory Disease Center
,
I Hirsch
1   Astrazeneca
,
F Trudo
1   Astrazeneca
,
M Alacqua
1   Astrazeneca
› Author Affiliations
Further Information

Publication History

Publication Date:
19 February 2019 (online)

 

Introduction Fixed airflow obstruction (FAO) is frequently associated with the severe eosinophilic asthma phenotype. Benralizumab, a humanized, afucosylated, anti–interleukin-5 receptor alpha monoclonal antibody, reduces exacerbations and improves lung function and daily symptoms in patients (pts) with severe, uncontrolled eosinophilic asthma. We assessed FAOʼs influence on benralizumab response.

MethodsPost-hoc analysis of pooled data from the Phase III SIROCCO (48 wks; Lancet. 2016;388 : 2115 – 27) and CALIMA (56 wks; Lancet. 2016; 388 : 2128 – 41) trials. Pts with severe, uncontrolled asthma aged ≥ 12 yrs with baseline (BL) blood eosinophils ≥ 300 cells/µL taking high-dosage ICS/LABA received benralizumab 30 mg SC every 4 (Q4W; n = 503) or 8 wks (Q8W; first 3 doses Q4W; n = 490) or placebo (PBO; n = 496). FAO was defined as postbronchodilator FEV1: FVC < 70%. Patients with (FAO+) and without FAO (FAO–) were identified at screening. Demographics, BL clinical characteristics, and treatment responses were evaluated by FAO status.

Results FAO prevalence was 63% (935/1,493 pts). At BL, pts who were FAO+ vs. FAO– were older (mean age [SD]: 51.3 [12.5] vs. 44.7 [14.9] yrs), had a longer median (range) time since asthma diagnosis (16.8 [1.1 – 69.9] vs. 13.3 [1.1 – 64.0] yrs), had a greater percentage of current OCS use (16.0% vs. 9.3%). More FAO+ than FAO– pts were former smokers (24.4% vs. 14.5%). Blood eosinophil counts (median [range]: 510 [300 – 4,494] vs. 490 [300 – 3,100] cells/µL) and prior hospitalizations for asthma (23.3% vs. 18.5%) were slightly greater for FAO+ vs. FAO– pts. The background exacerbation rate in PBO-treated pts was 1.32 vs. 0.86 for FAO+ vs. FAO− pts. For Q8W, reduction in overall annual asthma exacerbation rate vs. PBO was similar between FAO+ and FAO– groups (table). Greater reductions for FAO+ vs. FAO– were observed for those events associated with hospitalization or emergency room visit. Improvements in prebronchodilator FEV1, patient-reported outcomes, and symptoms were consistently greater for FAO+ vs. FAO– pts. A similar efficacy pattern was evident for Q4W.

Conclusion FAO was common in pts with severe eosinophilic asthma. Pts with FAO were older and had more severe BL disease. Add-on benralizumab improved asthma control across several measures for pts with severe eosinophilic asthma and FAO.