Sustained Effectiveness of Benralizumab in Naïve and Biologics-Experienced Severe Eosinophilic Asthma Patients: Results from the ANANKE Study

Figures & data

Table 1 Socio-Demographic and Clinical Characteristics of Naïve and Bio-Experienced Patients, Including Omalizumab and Mepolizumab Subsets, Collected Before Initiating Benralizumab Treatment

Characteristics at Index Date	Naïve (N=124)	Bio-Experienced (N=38)	Omalizumab (N=21)	Mepolizumab (N=17) (Including Four Patients Switched from Omalizumab)
Age (years)	56.6 ± 12.3	54.3 ± 13.7	59.1 ± 10.5	48.3 ± 15.0
Gender (female)	82 (66.1)	17 (44.7)	8 (38.1)	9 (52.9)
BMI classes
Underweight/Normal	47 (37.9)	11 (28.9)	4 (19.0)	7 (41.2)
Overweight	46 (37.1)	16 (42.1)	11 (52.4)	5 (29.4)
Obese	19 (15.3)	7 (18.4)	5 (23.8)	2 (11.8)
Unknown	12 (9.7)	4 (10.5)	1 (4.8)	3 (17.6)
Smoking status
Current smokers	4 (3.2)	1 (2.6)	0 (0.0)	1 (5.9)
Past smokers	31 (25.0)	13 (34.2)	8 (38.1)	5 (29.4)
Unknown	4 (3.2)	3 (7.9)	1 (4.8)	2 (11.8)
Asthma duration (years) (N=123, 38, 21, 17)	13.5 (8.1–26.4)	14.0 (8.5–20.5)	20.3 (9.4–30.1)	10.2 (6.5–14.8)
SEA duration (years) (N=120, 38, 21, 17)	1.6 (1.0–3.0)	3.5 (1.6–6.5)	2.1 (1.1–4.5)	4.6 (2.5–9.2)
Patients positive to ≥ 1 allergen	56 (45.2)	21 (55.3)	12 (57.1)	9 (52.9)
BEC (cells/mm^3)	605 (440–915)	550 (300–756)	550 (400–770)	550 (230–700)
Total serum IgE (IU/mL) (N=69, 22, 13, 9)	161 (73–474)	308 (128–620)	326 (78–520)	215 (172–774)
Duration of previous biologic treatment (months)	N/A	21.0 (10.6–52.9)	35.3 (15.9–92.0)	15.4 (10.6–27.4)
Any comorbidities	107 (86.3)	34 (89.5)	17 (81.0)	17 (100.0)
≥1 any asthma-related	71 (57.3)	20 (52.6)	9 (42.9)	11 (64.7)
CRSwNP (current or past)	68 (54.8)	18 (47.4)	5 (23.8)	13 (76.5)
CRSsNP	32 (25.8)	11 (28.9)	6 (28.6)	5 (29.4)
≥1 current OCS-related	44 (35.5)	20 (52.6)	11 (52.4)	9 (52.9)
≥1 other ongoing	20 (16.1)	7 (18.4)	4 (19.0)	3 (17.6)
OCS users (for asthma treatment)	30 (24.2)	11 (28.9)	4 (19.0)	7 (41.2)
OCS daily dose (mg) (N=28, 11, 4, 7)	8.1 (5.0–21.3)	10.0 (5.0–25.0)	5.0 (5.0–7.5)	25.0 (10.0–25.0)
Exacerbations
Patients with ≥1, any (N=117, 37, 20, 17)	109 (93.2)	35 (94.6)	20 (100.0)	15 (88.2)
Patients with ≥1, severe (N=117, 37, 20, 17)	39 (33.3)	18 (48.6)	11 (55.0)	7 (41.2)
AER, any (N=117, 37, 20, 17)	4.15	3.95	3.80	4.12
AER, severe (N=117, 37, 20, 17)	0.81	1.51	1.70	1.29
Lung function
Pre-BD FEV1 (L) (N=82, 29, 18, 11)	1.8 (1.4–2.5)	2.1 (1.4–2.4)	2.0 (1.4–2.4)	2.2 (1.0–2.7)
Pre-BD FEV1 predicted (%) (N=83, 30, 18, 12)	72.0 (54.0–85.0)	71.0 (48.0–84.0)	71.0 (48.0–81.0)	71.5 (39.5–89.0)
Post-BD FEV1 (L) (N=58, 14, 7, 7)	2.0 (1.4–2.7)	2.1 (1.4–3.0)	2.8 (1.3–3.4)	1.9 (1.4–3.0)
Post-BD FEV1 predicted (%) (N=56, 14, 7, 7)	73.0 (60.0–91.5)	66.5 (47.0–110)	90.0 (50.0–117)	49.0 (42.0–97.0)
Pre-BD FVC (L) (N=80, 28, 18, 10)	2.7 (2.2–3.4)	3.0 (2.5–3.7)	3.2 (2.7–3.9)	2.9 (2.4–3.3)
Post-BD FVC (L) (N=56, 12, 7, 5)	3.0 (2.3–3.8)	3.3 (2.4–4.4)	3.7 (2.4–5.0)	2.9 (2.3–3.2)
ACT score (N=90, 30, 16, 14)	14.0 (12.0–18.0)	14.0 (12.0–17.0)	15.0 (12.5–17.0)	12.5 (10.0–15.0)

Notes: Data were collected at index date and are expressed as N (%), mean ± SD, or median (IQR). Unless otherwise specified, N=124 patients were evaluated in the naïve group, N=38 patients in the bio-experienced group, N=21 patients in the omalizumab group, and N=17 patients in the mepolizumab group.

Abbreviations: N, number of patients; SEA, severe eosinophilic asthma; BEC, blood eosinophil count; IgE, immunoglobulin E; CRSwNP, chronic rhinosinusitis with nasal polyposis; CRSsNP, chronic rhinosinusitis without nasal polyps; OCS, oral corticosteroids; AER, annual exacerbation rate; Pre-BD FEV₁, pre-bronchodilator forced expiratory volume in 1 second; Pre-BD FVC, pre-bronchodilator forced vital capacity; Post-BD FEV₁, post-bronchodilator forced expiratory volume in 1 second; Post-BD FVC, post-bronchodilator forced vital capacity; ACT, asthma control test.

Table 2 Proportion of Patients Free from Severe Exacerbations Before and During Benralizumab Treatment in Naïve, Bio-Experienced, Omalizumab, and Mepolizumab Groups

	Naïve (N=117, 110, 86)	Bio-Experienced (N=37, 35, 27)	Omalizumab (N=20, 20, 17)	Mepolizumab (N=17, 15, 10)
Patients without severe exacerbations at index date, N (%)	78 (66.7)	19 (51.4)	9 (45.0)	10 (58.8)
Patients without severe exacerbations at 48 weeks, N (%)	106 (96.4)	30 (85.7)	16 (80.0)	14 (93.3)
Patients without severe exacerbations at 96 weeks, N (%)	84 (97.7)	23 (85.2)	14 (82.4)	9 (90.0)

Notes: Data were collected at index date and at 48 and 96 weeks of benralizumab treatment; data are expressed as N (%).

Abbreviation: N, number of patients.

Figure 1 AER reduction during benralizumab treatment in naïve, bio-experienced, omalizumab, and mepolizumab groups. Any (A) and severe (B) AER are shown at index date and after 48 and 96 weeks of treatment with benralizumab.

Figure 2 Change in pre-BD respiratory parameters during benralizumab treatment in naïve, bio-experienced, omalizumab, and mepolizumab groups. Median pre-BD FEV₁ (A) and pre-BD FVC (B) are shown at various time points (index date and 4, 16, 24, 48, and 96 weeks of treatment with benralizumab).

Figure 3 Long-term OCS reduction during benralizumab treatment in naïve, bio-experienced, omalizumab, and mepolizumab groups. OCS daily dose (mg of prednisone equivalent), expressed as median (IQR), is shown at index date and after 48 and 96 weeks of treatment with benralizumab.

Table 3 Proportion of Patients Achieving OCS Dose Reduction and/or Interruption During Benralizumab Treatment in Naïve, Bio-Experienced, Omalizumab, and Mepolizumab Groups After 48 and 96 Weeks

OCS Reduction from Index Date	Naive at 48 Weeks N (%) (N=25)	Naive at 96 Weeks N (%) (N=22)	Bio-Experienced at 48 Weeks N (%) (N=9)	Bio-Experienced at 96 Weeks N (%) (N=8)	Omalizumab at 48 Weeks N (%) (N=3)	Omalizumab at 96 Weeks N (%) (N=3)	Mepolizumab at 48 Weeks N (%) (N=6)	Mepolizumab at 96 Weeks N (%) (N=5)
Interruption	13 (52.0)	14 (63.6)	5 (55.6)	4 (50.0)	1 (33.3)	1 (33.3)	4 (66.7)	3 (60.0)
Any reduction (including interruption)	15 (60.0)	15 (68.2)	6 (66.7)	5 (62.5)	2 (66.7)	2 (66.7)	4 (66.7)	3 (60.0)
≥90% dose reduction	13 (52.0)	14 (63.6)	5 (55.6)	4 (50.0)	1 (33.3)	1 (33.3)	4 (66.7)	3 (60.0)
≥75% dose reduction	13 (52.0)	14 (63.6)	5 (55.6)	4 (50.0)	1 (33.3)	1 (33.3)	4 (66.7)	3 (60.0)
≥25% dose reduction	15 (60.0)	15 (68.2)	5 (55.6)	4 (50.0)	1 (33.3)	1 (33.3)	4 (66.7)	3 (60.0)
No reduction	10 (40.0)	7 (31.8)	3 (33.3)	3 (37.5)	1 (33.3)	1 (33.3)	2 (33.3)	2 (40.0)

Notes: OCS dosage is expressed as daily mg (prednisone equivalent). Data are expressed as N (%).

Abbreviations: N, number of patients; OCS, oral corticosteroids.

Figure 4 Improvement in asthma control during benralizumab treatment in naïve, bio-experienced, omalizumab, and mepolizumab groups. Median change in ACT score (A) and percentage of patients achieving a well-controlled asthma (ACT score ≥20) (B) are shown at various time points (index date and 4, 16, 24, 48, and 96 weeks of treatment with benralizumab).