Table 1.
A summary of efficacy results from recent intravenous immunoglobulin (IVIG) clinical trials performed in the United States
| Parameter | Gamunex 10 % | Gamimune N 10 % | Octagam 5 % | Gammagard liquid 10 % | Flebogamma 5 % DIF | Privigen 10 % | Flebogamma 10 % DIF | Gammaplex 5 % | Biotest 10 % IVIG |
|---|---|---|---|---|---|---|---|---|---|
| Subjects (N) | PP = 73 | PP = 73 | 46 | 61 | 50 | 80 | 46 | 50 | 63 |
| Age (years), mean (range) | 35.1 | 29.5 | 31 (6–74) | 34 (6–72) | 38.9 (15–75) | 28 (3–69) | 36.8 (6–65) | 44.0 (9–78) | 41.2 (6–75) |
| Treatment groups | 21 days = 9 | 21 days = 14 | 21 days = 19 | NR | 21 days = 13 | 21 days = 16 | 21 days = 16 | 21 days = 22 | 21 days = 17 |
| 28 days = 64 | 28 days = 59 | 28 days = 27 | 28 days = 33 | 28 days = 64 | 28 days = 30 | 28 days = 28 | 28 days = 46 | ||
| Diagnosis | ITT = 87 | ITT = 85 | |||||||
| CVID | 46 (53 %) | 44 (52 %) | 28 (61) % | NR | 35 (76.1 %) | 59 (73.8 %) | 37 (80.4 %) | 46 (92 %) | 51 (81 %) |
| XLA | 13 (28 %) | 10 (21.7 % | 21 (26.2 %) | 8 (17.4 %) | 4 (8 %) | 6 (9.5 %) | |||
| Hypogam | 39 (45 %) | 35 (41 %) | |||||||
| Combined ID | 1 (1 %) | 5 (6 %) | |||||||
| Other | 1 (1 %) | 1 (1 %) | 5 (11 %) | 1 (2.2 %) | 1 (2.1 %) | 2 (905 %) | |||
| Serious infections, no. of patients (%) | 9 (12.3%)a | 17 (23.3%)a | 3 | 0 | 1 | 6 | 1 | 0 | 2 |
| Serious infections, no. of patients (%) | 0.18 | 0.43 | 0.12 (upper 98 % CI = 0.279) | 0 (upper 95 % CI = 0.060) | 0.012 (upper 98 % CI = 0.112) | 0.08 (upper 97.5 % CI = 0.182) | 0.025 (upper 98 % CI = 0.133) | 0 (upper 99 % CI = 0.101) | 0.037 (upper 99 % CI = 0.101) |
| Other infection rate (no./patient/year) | 3.4 | 1.96 | 3.55 | 2.2 | 3.28 | 2.6 | |||
| Missed work/school, days/patient/year (range) | 5 (0–22) | 13 (0–257) | 7.94 | 3 | 8.7 ± 34.4 | 2.28 | |||
| Hospitalizations, days/patient/year (range) | 0.3 (0–6) | 0.77 | 2.31 | 0.6 | 0.75 | 0.21 | |||
| Unscheduled physician/ER visits, mean/patient/year (range) | 2 (0–11) | 4.3 (0–34) | 2.1 | 5.55 (0–42.1) | |||||
| Therapeutic antibiotics (days/patient/year) | 55.6 | 57.7 | 47.2 | ||||||
| Prophylactic antibiotics (days/patient/year) | 81.1 | 46.1 | 7 subjects continuous; 33 courses in 16 patients | ||||||
| Total antibiotics (days/patient/year) | 136.7 | 87.4 | 103.8 | 82 | |||||
| IgG half-life (days) | 35 | 34 | 41 ± 17 | 35 (95 % CI = 31–42) |
21 days = 30 ± 9 28 days = 32 ± 5 |
21 days = 34 ± 10 28 days = 37 ± 13 |
41.1 |
21 days = 20 ± 4 28 days = 34 ± 11 |
|
| Trough IgG (mg/dL) | NR | NR |
21 days = 986 28 days = 883 |
960–1,120 |
21 days = 951 ± 132 28 days = 900 ± 92 |
884–1,027 | NR |
21 days = 936–1,240b 28 days = 833–1,140b |
21 days = 1,076 ± 254 28 days = 943 ± 215 |
NR not reported
aSerious infections were defined as “validated” infections and included acute sinusitis, acute exacerbation of chronic sinusitis, or pneumonia according to diagnostic criteria defined prospectively
bMedian values