Table 1.
Efficacy Outcomes in Pediatric Subjects (Age ≤17 Years) Treated Long Term with Subcutaneous C1 Inhibitor
| Subject | Age at study entry (years) | C1INH (SC) treatment status | C1INH (SC) dose at randomization (IU/kg) | Duration of C1INH (SC) exposure in efficacy evaluation (weeks)a | Attack rate with C1INH (SC) prophylaxis (attacks/month) | % reduction in attacks/month relative to prestudy period |
|---|---|---|---|---|---|---|
| 1 | 8 | Naïve | 40 | 50 | 0.09 | 97 |
| 2 | 10 | Naïve | 60 | 51 | 0 | 100 |
| 3 | 10 | Naïve | 40 | 120 | 0.04 | 96 |
| 4 | 13 | Naïve | 60 | 50 | 0.26 | 96 |
| 5 | 14 | Previously treated | 40 | 126 | 0.24 | 93 |
| 6 | 15 | Previously treated | 60 | 49 | 0.79 | 76 |
| 7 | 15 | Previously treated | 40 | 128 | 0.14 | 97 |
| 8 | 16 | Previously treated | 40 | 52 | 0.92 | 77 |
| 9 | 16 | Previously treated | 60 | 131 | 0.03 | 98 |
| 10 | 16 | Naive | 60 | 114 | 0.04 | 99 |
a
The first 2 weeks of treatment were excluded from the efficacy analyses.
C1INH (SC), subcutaneous C1 inhibitor.