Clinical Features and Efficacy of Benralizumab in Patients with Blood Eosinophil Count Between 300 and 450 Cells/mm³: A Post Hoc Analysis from the ANANKE Study

Figures & data

Table 1 Demographics, Clinical and Laboratory Features of the Patient Population

Characteristics at Index Date			Total Population (N=164)	BEC 300–450 (N=34)
Female (%)	Number (percentage)		101 (55.8%)	22 (64.7%)
Age (years)	Mean (SD)		56.5 (12.6)	56.1 (13.0)
Age at diagnosis of asthma (years)	Mean (SD)		38.9 (16.1)	39.1 (15.4)
Duration of asthma (years) (N=203)	Median (IQR)		13.4 (8.0–24.9)	12.4 (8.0–24.0)
Blood eosinophil count (cells/mm^3)	Median (IQR)		575 (415–848)	400 (350–440)
Total serum IgE (IU/mL) (N=95, 19)	Median (IQR)		236 (73.3–545)	138 (67–362)
Atopy (%)	Number (percentage)		67 (40.9%)	13 (38.2%)
BMI	Class, number (percentage)	Under/Normal	57 (34.7%)	11 (32.3%)
		Overweight	65 (39.6%)	17 (50.0%)
		Obese	27 (16.5%)	4 (11.8%)
		Data unknown	15 (9.1%)	2 (5.9%)
Smoking status	Class, number (percentage)	Non-smoker	106 (64.6%)	25 (73.5%)
		Previous smoker	44 (26.8%)	7 (20.6%)
		Current smoker	6 (3.7%)	0 (0.0%)
		Data unknown	8 (4.9%)	2 (5.9%)
Pre-bronchodilator FEV1 (liters) (N=124, 25)	Mean (SD)		1.9 (0.8)	1.9 (0.9)
Pre-bronchodilator FEV1 (% predicted) (N=127, 25)	Mean (SD)		70.0 (20.9)	73.4 (25.2)
Post-bronchodilator FEV1 (liters) (N=79, 17)	Mean (SD)		2.1 (0.8)	2.1 (0.9)
Post-bronchodilator FEV1 (% predicted) (N=77, 16)	Mean (SD)		77.3 (21.7)	75.1 (25.9)
Pre-bronchodilator FVC (liters) (N=118, 23)	Mean (SD)		2.9 (1.0)	2.8 (1.0)
Pre-bronchodilator FEV1/FVC (ratio) (N=118, 23)	Mean (SD)		0.7 (0.2)	0.7 (0.2)
ACT score (N=115, 25)	Median (IQR)		14 (12–18)	15 (12–17)
OCS use	Number (percentage)		43 (26.2%)	8 (23.5%)
OCS dose at index date (N=39, 7)	Median (IQR)		10 (5–25)	5 (5–25)
Annualized exacerbation rate (N=157, 32)			3.87	3.66
Annualized severe exacerbation rate (N=157, 32)			1.01	0.69

Abbreviations: BEC, blood eosinophil count, measured in cells/mm³; BMI, body mass index; FEV₁, forced expiratory volume in the first second; FVC, forced vital capacity; ACT, asthma control test; OCS, oral corticosteroids; SD, standard deviation; IQR, interquartile range (25%–75%).

Table 2 List and Percentage of Comorbidities Within the Study Population

	Total Population (N=164)	BEC 300–450 (N=34)
≥1 relevant comorbidity	144 (87.8%)	30 (88.2%)
≥1 current asthma-related condition	90 (54.9%)	18 (52.9%)
Nasal polyposis	89 (54.3%)	19 (55.9%)
GERD	40 (24.4%)	9 (26.5%)
Allergic conjunctivitis	24 (14.6%)	4 (11.8%)
Allergic rhinitis	36 (22%)	6 (17.6%)
≥1 current OCS-related condition	60 (40.2%)	17 (50%)
Hypertension	41 (25%)	6 (17.6%)
Osteoporosis	20 (12.2%)	7 (20.6%)
Cataracts	11 (6.7%)	5 (14.7%)
Anxiety/Depression	7 (4.2%)	4 (11.7%)
Type 2 diabetes mellitus	9 (5.5%)	2 (5.9%)
Obstructive sleep apnea	8 (4.9%)	3 (8.8%)
Cardiovascular disease	7 (4.3%)	3 (8.8%)
≥1 other ongoing comorbidities	28 (17.1%)	7 (20.6%)
Thyroid disorders	8 (4.9%)	2 (5.9%)
Bronchiectasis	6 (3.7%)	2 (5.9%)

Abbreviations: GERD, gastroesophageal reflux disease; OCS, oral corticosteroids; BEC, blood eosinophil count, measured in cells/mm^3.

Figure 1 Annualized exacerbation rates (AER) of any severity (A) and for severe exacerbations (B) during benralizumab treatment in severe eosinophilic asthma (SEA) patients with BEC 300–450 cells/mm³ and in the total population (N=157 at baseline, N=135 at 48 weeks in the total population; N=32 at baseline, N=28 at 48 weeks in the BEC 300–450 subset); (C) Asthma control test (ACT) improvement at different timepoints in total population and BEC 300–450 subset; (D) Pre-BD FEV₁ (pre-bronchodilator forced expiratory volume in the first second) change over time in total population and BEC 300–450 subgroup.

Table 3 OCS Reduction at End of Observation in the Patient Population

Variable	Total Population (N=29)	BEC 300–450 (N=5)
Reduction from baseline (%)
100	16 (55.2%)	5 (100%)
≥90	16 (55.2%)	5 (100%)
≥75	16 (55.2%)	5 (100%)
≥25	16 (55.2%)	5 (100%)
Any reduction	16 (55.2%)	5 (100%)
No reduction	13 (44.8%)	0 (0%)

Abbreviations: BEC, blood eosinophil count, measured in cells/mm³; OCS, oral corticosteroids.

Figure 2 Oral corticosteroids (OCS) sparing effect of benralizumab in severe eosinophilic asthma (SEA) patients with BEC 300–450 cells/mm³ and in the total population. The dose is reported in milligrams of prednisone-equivalent.