Efficacy of CINRYZE in Pediatric Patients (6+)

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
Period
3.7
CINRYZE
500 U
1.2
CINRYZE
1,000 U
0.7

  • 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.

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Reference

  1. CINRYZE® (C1 esterase inhibitor [human]) Prescribing Information. Shire.
  2. Aygoren-Pursun et al., Pediatr Allergy Immunol. 2019;00: 1–9.

Definition: