Table 1.
Demographics And Baseline Clinical Characteristics Of Benralizumab 2-Year Integrated Analysis Patients (FAS)a
| SIROCCO/CALIMA Blood Eosinophil Counts ≥300 Cells/μL | ||
|---|---|---|
| Benralizumab 30 mg Q4W (n=323) | Benralizumab 30 mg Q8W (n=318) | |
| Age (years), mean (SD) | 49.4 (13.1) | 48.0 (14.5) |
| Age group (years), n (%) | ||
| ≥12–<18 | 11 (3) | 17 (5) |
| ≥18–75 | 312 (97) | 301 (95) |
| Sex, n (%) | ||
| Male | 118 (37) | 129 (41) |
| Female | 205 (64) | 189 (59) |
| Race, n (%) | ||
| White | 245 (76) | 237 (75) |
| Black or African-American | 5 (2) | 7 (2) |
| Asian | 56 (17) | 53 (17) |
| Otherb | 17 (5) | 21 (7) |
| Ethnic group, n (%) | ||
| Hispanic or Latino | 71 (22) | 64 (20) |
| Not Hispanic or Latino | 252 (78) | 254 (80) |
| BMI (kg/m2), mean (SD) | 28.9 (7.4) | 27.8 (6.0) |
| Eosinophil count (cells/µL), median (range) | 470 (0–2800) | 460 (10–3110) |
| Prebronchodilator FEV1 (L), mean (SD) | 1.7 (0.55) | 1.7 (0.62) |
| Prebronchodilator FEV1 (% predicted normal), mean (SD) | 57.8% (13.8) | 57.4% (14.5) |
| Reversibility (%), median (range) | 24.9% (24.5) | 24.1% (22.2) |
| Prebronchodilator FEV1/FVC, mean (SD) | 61.6 (11.4) | 60.4 (12.5) |
| ACQ-6 score, mean (SD) | 2.7 (0.9) | 2.7 (0.9) |
| Time since asthma diagnosis (years), median (range) | 14.7 (1.3–66.2) | 15.4 (1.1–58.3) |
| Number of exacerbations in the past 12 months | 2.9 (1.8) | 2.7 (1.4) |
| 2 exacerbations, n (%) | 199 (62) | 200 (63) |
| ≥3 exacerbations, n (%) | 124 (38) | 118 (37) |
| Patients with ≥1 exacerbation in the past 12 months resulting in hospitalizations or ED visits, n (%) | 93 (29) | 98 (31) |
| AQLQ(S)+12 score, mean (SD) | 4.0 (1.0) | 3.9 (1.0) |
Notes: aBaseline data from preceding pivotal studies. bNative Hawaiian or “other” Pacific Islander, American Indian or Alaska Native and other.
Abbreviations: ACQ-6, Asthma Control Questionnaire 6; AQLQ(S)+12, Asthma Quality of Life Questionnaire (standardized) for 12 years and older; BMI, body mass index; ED, emergency department; FAS, full analysis set; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; Q4W, every 4 weeks; Q8W, every 8 weeks (first three doses Q4W); SD, standard deviation.