Table 2. . Baseline demographic and disease characteristics studies in the evidence network.
| Regimen | HELP [13,35] | APeX-2 [17] | CHANGE [20,23] | |||||
|---|---|---|---|---|---|---|---|---|
| Lanadelumab 300 mg Q2W (n = 27) | Lanadelumab 300 mg Q4W (n = 29) | Placebo (n = 41) | Berotralstat 150 mg q.d. (n = 40) | Berotralstat 110 mg q.d. (n = 41) | Placebo (n = 40) | C1-INH first (n = 11) | Placebo first (n = 11) | |
| Mean (SD) age, years | 40.3 (13.3) | 39.5 (12.8) | 40.1 (16.8) | 40.0 (14.0) | 40.4 (17.5) | 44.5 (14.1) | 41.7 (19.3) | 34.5 (14.8) |
| Mean (SD) body weight, kg | 90.6 (25.2) | 78.5 (16.6) | 76.3 (22.7) | 87.6 (20.4) | 78.8 (21.5) | 84.9 (21.4) | 70.5 (9.3) | 76.3 (25.7) |
| Mean (SD) BMI, kg/m2 | 31.0 (7.8) | 28.1 (5.1) | 27.5 (7.7) | 30.4 (6.7) | 27.5 (7.3) | 29.3 (6.8) | NR | NR |
| Female, n (%) | 15 (55.6) | 19 (65.5) | 34 (82.9) | 23 (57.5) | 30 (73.2) | 27 (67.5) | 9 (81.8) | 11 (100) |
| White, n (%) | 26 (96.3) | 23 (79.3) | 39 (95.1) | 38 (95.0) | 38 (92.7) | 37 (92.5) | 10 (90.9) | 11 (100) |
| HAE type, n (%) | ||||||||
| Type I | 23 (85.2) | 27 (93.1) | 38 (92.7) | NR | NR | NR | 9 (81.8) | 9 (81.8) |
| Type II | 4 (14.8) | 2 (6.9) | 3 (7.3) | NR | NR | NR | 2 (18.2) | 2 (18.2) |
| Mean (SD) run-in/baseline attack rate, attacks/month | 3.5 (2.3) | 3.7 (2.5) | 4.0 (3.3) | 3.1 (1.6) | 3.0 (1.4) | 2.9 (1.1) | 3.8 (2.0)† | |
| Prior use of prophylaxis, n (%) | 14 (51.9) | 20 (69.0) | 24 (58.5) | 30 (75.0) | 32 (78.0) | 29 (72.5) | NR | NR |
†
Because the CHANGE study has a crossover design, published literature only reports baseline attack rate for C1-INH first and placebo first arms combined.
C1-INH: C1 inhibitor; HAE: Hereditary angioedema; NR: Not reported; Q2W: Every 2 weeks; Q4W: Every 4 weeks; q.d.: Once daily; SD: Standard deviation.