Table 1.
Patient demographics and baseline characteristics (safety analysis set)
| Parameter | Volume Cohort (N = 15) | Flow Rate Cohort (N = 18) |
|---|---|---|
| Age, years | ||
| Mean (SD) | 49.1 (14.2) | 26.7 (24.5) |
| Median (min, max) | 50.0 (19, 75) | 15.0 (2, 75) |
| Age category, years | ||
| ≤ 17 | 0a | 10 (55.6) |
| < 16 | 0a | 9 (50.0) |
| > 17 | 15 (100.0) | 8 (44.4) |
| Sex, n (%) | ||
| Male | 6 (40.0) | 8 (44.4) |
| Female | 9 (60.0) | 10 (55.6) |
| Race, n (%) | ||
| White | 14 (93.3) | 16 (88.9) |
| American Indian or Alaska Native | 0 | 1 (5.6) |
| Black or African American | 0 | 1 (5.6) |
| Multiple | 1 (6.7) | 0 |
| Weight, kg | ||
| Mean (SD) | 80.1 (21.0) | 52.6 (26.1) |
| Median (min, max) | 71.4 (55.8, 143.1) | 59.0 (11.3, 88.8) |
| BMI, kg/m2 | ||
| Median (min, max) | 27.7 (23.2, 58.1) | 22.3 (13.4, 31.4) |
| BMI category, n (%) | ||
| < 30 kg/m2 | 11 (73.3) | 15 (83.3) |
| ≥ 30 kg/m2 | 4 (26.7) | 3 (16.7) |
| Concomitant diseases (≥ 4 patients in each cohort), n (%) | ||
| Any concomitant disease | 15 (100) | 18 (100) |
| Asthma | 9 (60.0) | 7 (38.9) |
| Rhinitis allergic | 7 (46.7) | 7 (38.9) |
| Immunodeficiency disease, n (%) | ||
| Common variable immunodeficiency | 11 (73.3) | 8 (44.4) |
| Congenital agammaglobulinemia | 1 (6.7) | 1 (5.6) |
| Other immunodeficiencyb | 3 (20.0) | 9 (50.0) |
| Time since first PID diagnosis, years | ||
| Mean (SD) | 11.1 (13.0) | 5.2 (6.0) |
| Median (min, max) | 5.0 (0.8, 45.0) | 2.3 (0.2, 23.0) |
| IgG levels at time of first PID diagnosis, g/L | ||
| n | 11 | 14 |
| Mean (SD) | 4.3 (2.4) | 4.1 (2.8) |
| Median (min, max) | 5.5 (1.0, 7.0) | 4.7 (0.1, 9.2) |
| Pre-study IgG trough levels, g/L | ||
| n | 15 | 18 |
| Mean (SD) | 11.2 (2.8) | 9.6 (3.0) |
| Median (min, max) | 11.6 (6.9, 16.1) | 9.9 (1.5, 14.2) |
aPatients were required to have a total weekly IgPro20 dose of ≥ 50 mL to be eligible for enrollment in this cohort. This dose is not pertinent for pediatric patients because IgPro20 doses need to be adjusted based on patient body weight
bOther immunodeficiency category includes combined immunodeficiency, specific antibody deficiency, hypogammaglobulinemia, IgG deficiency, Bruton’s agammaglobulinemia, polysaccharide non-response immunodeficiency, and ZAP70 immunodeficiency
BMI body mass index, IgG immunoglobulin G, PID primary immunodeficiency, SD standard deviation