From: 13th C1-inhibitor deficiency and angioedema workshop—2023
Placebo N = 51 | PHVS416 10 mg N = 37 | PHVS416 20 mg N = 28 | PHVS416 30 mg N = 31 | Combined PHVS416* N = 96 | |
---|---|---|---|---|---|
Mean VAS-3 at pre-treatment | 27.76 | 26.16 | 25.46 | 29.73 | 27.11 |
Change in VAS-3 at 4 h | |||||
Least-squares mean difference: | |||||
PHVS416—placebo | − 16.75 | − 15.02 | − 16.28 | − 16.08 | |
p-value | < 0.0001 | < 0.0001 | < 0.0001 | ||
Time to onset of symptom relief by VAS-3 ≥ 30% reductiona | |||||
Median time in hours (95% CI) | 8.0 (7.6, 46.9) | 2.1 (1.5, 2.9) | 2.7 (1.9, 3.5) | 2.5 (1.9, 3.8) | 2.4 (2.0, 2.9) |
Hazard ratio | 3.81 | 3.08 | 3.61 | ||
p-value | < 0.0001 | 0.0021 | < 0.0001 | ||
Time to VAS-3 ≥ 50% reductiona | |||||
Median time in hours (95% CI) | 22.8 (20.0, 24.1) | 3.3 (2.4, 3.9) | 4.0 (2.9, 6.0) | 4.0 (3.3, 5.8) | 3.9 (3.0, 4.8) |
Hazard ratio | 4.55 | 3.65 | 3.87 | ||
p-value | < 0.0001 | 0.0003 | < 0.0001 | ||
Time to almost complete or complete symptom relief by VAS-3a | |||||
Median time in hours (95% CI) | 42.0 (22.0, 48.1) | 5.8 (3.6, 7.5) | 20.0 (4.5, 20.0) | 20.0 (6.0, 20.1) | 7.5 (5.9, 20.0) |
Hazard ratio | 5.09 | 2.25 | 2.65 | ||
p-value | < 0.0001 | 0.0127 | 0.0001 | ||
Change in MSCS score at 4 hoursb | |||||
Least-squares mean difference: | |||||
PHVS416—placebo | − 0.79 | − 0.61 | − 0.39 | − 0.61 | |
p-value | < 0.0001 | 0.0008 | 0.0291 | ||
TOS at 4 hoursb | |||||
Least-squares mean difference: | |||||
PHVS416—placebo | 64.13 | 62.69 | 71.06 | 66.05 | |
p-value | < 0.0001 | < 0.0001 | < 0.0001 |