Table 1 Subject Demographics by Treatment Sequence (ITT Population)
Prolastin/Prolastin-C (n = 12) | Prolastin-C/Prolastin (n = 12) | All Subjects (n = 24) | |
|---|---|---|---|
Mean age, y (SD) | 57.0 (9.33) | 58.4 (6.86) | 57.7 (8.04) |
Mean body weight, kg (SD) | 81.4 (15.37) | 89.7 (19.49) | 85.5 (17.67) |
Male gender, n (%) | 4 (33.3) | 6 (50.0) | 10 (41.7) |
Female gender, n (%) | 8 (66.7) | 6 (50.0) | 14 (58.3) |
Time since AAT deficiency diagnosis, y (SD) | 8.69 (6.96) | 9.10 (6.02) | 8.89 (6.37) |
Mean pre-augmentation alpha1-PI plasma level, μM (SD) | 5.29 (1.90) | 4.92 (2.01) | 5.11 (1.92) |
Mean baseline alpha1-PI serum level, μM (SD)* | 17.7 (3.26) | 19.8 (4.38) | 18.7 (3.91) |
Mean FEV1 predicted, % (SD) | 43.8 (13.2) | 41.8 (13.8) | 42.8 (13.3) |
Deficiency genotype, n (%) | |||
PiZZ | 12 (100) | 11 (91.7) | 23 (95.8) |
PiSZ | 0 | 1 (8.3) | 1 (4.2) |
Prior Prolastin therapy, n (%) | 12 (100) | 12 (100) | 24 (100) |
Medical history, n (%)† | |||
Obstructive pulmonary diseases‡ | |||
COPD | 8 (66.7) | 7 (58.3) | 15 (62.5) |
Emphysema | 6 (50.0) | 7 (58.3) | 13 (54.2) |
Bronchiectasis | 3 (25.0) | 2 (16.7) | 5 (20.8) |
Asthma | 3 (25.0) | 3 (25.0) | 6 (25.0) |
Other conditions | |||
Headache | 3 (25.0) | 4 (33.3) | 7 (29.2) |
Pneumonia | 2 (16.7) | 3 (25.0) | 5 (20.8) |
Depression | 2 (16.7) | 3 (25.0) | 5 (20.8) |
Hypertension | 2 (16.7) | 3 (25.0) | 5 (20.8) |