Indication CINRYZE® (C1 esterase inhibitor [human]) is indicated for routine prophylaxis against angioedema attacks in adults, adolescents and pediatric patients (6 years of age and older) with Hereditary Angioedema (HAE).
In pediatric patients (age 7 to 11), CINRYZE was shown to reduce the number of HAE attacks, lessen the severity of attacks, and reduce the use of acute treatment compared to baseline.1
CINRYZE was shown to reduce the frequency of HAE attacks in 12 pediatric patients (7-11 years old).2
Reduction in frequency of attacks in pediatric patients
Time-normalized mean number of HAE attacks per month
4
3.5
3
2.5
2
1.5
1
.5
0
Observation Period3.7
CINRYZE 500 U1.2
CINRYZE 1,000 U0.7
CINRYZE demonstrated a reduction in the number HAE attacks from baseline
71.1% and 84.5% mean reduction in attacks (500 U and 1,000 U, respectively)
Mean absolute reduction in number of attacks: -2.6 (500 U), -3.0 (1,000 U)
Study design:
A randomized, single-blind, multi-center, dose-ranging cross-over study in 12 pediatric patients with HAE (7 to 11 years old). After an observation period of 12 weeks, patients were randomized to receive either CINRYZE 500 U or CINRYZE 1,000 U every 3 to 4 days for 12 weeks. Patients were then crossed-over to the alternative dose for an additional 12-week period. Efficacy endpoints that were met included reduction in the number of attacks, along with lessened severity of attacks and reduction in the use of acute treatment compared with baseline.1
CINRYZE was proven to reduce the severity of HAE attacks and reduce the use of acute treatment in pediatric patients2
Results from a clinical study in 12 children (7-11 years old) receiving CINRYZE (500 U and 1,000 U)
Average change in the severity of attacks per month vs baseline observationa
-5.2 and -5.8 with 500 U and 1,000 U, respectively
Change in the number of attacks requiring acute treatment per month vs baseline observation
-1.6 and -1.9 with 500 U and 1,000 U, respectively
aSeverity of attacks were measured on a 3-point scale (1=mild, 2=moderate, and 3=severe). Results are the decrease in the total of the symptom severity score for each attack.