ABOUT CINRYZE

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Effectiveness of CINRYZE

Any time you're considering a new medication, the best thing you can do is talk with your doctor. It's also a good idea to learn about the safety and effectiveness of the medicine you're thinking about trying. The effect of CINRYZE has been studied in adults, teenagers and children (7-11 years old).


Proven Preventive Therapy for Children

In a clinical study, CINRYZE® (C1 esterase inhibitor [human]) helped prevent HAE attacks in children (aged 7+)

Children (aged 7-11 years old)

Number of HAE attacks per month during 12-week observation period and 12-week treatment period
Mean (average)
CINRYZE 500 U
(12 Patients)
1.2
CINRYZE 1,000 U
(12 Patients)
0.7
Baseline observation
(12 Patients)
3.7

  • CINRYZE demonstrated a reduction in the number of HAE attacks (71.1% and 84.5% mean reduction with 500 U and 1,000 U, respectively) vs. baseline observation attack rate per month.
  • Both doses of CINRYZE also reduced the severity of attacks and use of acute treatment vs baseline

In children, CINRYZE was proven to reduce the severity of HAE attacks and reduce the use of acute treatment

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.

Pediatric Patient Study Design

The safety and effectiveness of CINRYZE were evaluated in a 36-week clinical trial in 12 children (7 to 11 years old) with HAE. Children were observed for 12 weeks to establish the baseline observation attack rate and then were given 1 dose of CINRYZE (500 U or 1,000 U) every 3 or 4 days for 12 weeks and then switched to the other dose for the last 12 weeks. Effectiveness was measured as reduction in the number of attacks at 12 weeks for each treatment dose compared with the baseline observation attack rate.



Proven Preventive Therapy for Adults and Teenagers

In a clinical study, CINRYZE® (C1 esterase inhibitor [human]) helped prevent HAE attacks

Number of HAE attacks per month during 12-week observation period and 12-week treatment period
Mean (average)
CINRYZE
(22 Patients)
6.1
PLACEBO
(22 Patients)
12.7

  • The majority of people had fewer attacks while on CINRYZE than while on placebo
  • The response to CINRYZE varied:
    • 20 people had fewer attacks, ranging from 100% to 1% fewer attacks
      — 4 people had no attacks
    • 2 people had more attacks, ranging from 8% to 85% more attacks

CINRYZE was proven to reduce the severity of HAE attacks in adults and teenagers.

Results from a clinical study with CINRYZE in adults and teenagers
Decrease in the average duration of attacks
Attacks lasted 2.1 days while taking CINRYZE vs 3.4 days while taking placebo
Fewer days of swelling
66% reduction in days of swelling, from an average of 10.1 days of swelling over 12 weeks while taking CINRYZE, to 29.6 days while taking placebo
Decrease in the average severity of attacks
On a 3-point scale (1=mild, 2=moderate, 3=severe), attacks while taking CINRYZE were ranked as less severe than were attacks while taking placebo (1.3 vs 1.9)

Adults and Teenager Study Design

The safety and effectiveness of CINRYZE were evaluated in a 24-week clinical trial in 24 patients (9 to 73 years old) diagnosed with HAE. People in the study were divided into 2 groups: Group 1 received CINRYZE 1,000 U for the first 12 weeks and were switched to placebo for the last 12 weeks. Group 2 received placebo for the first 12 weeks and were switched to CINRYZE 1,000 U for the last 12 weeks. Effectiveness was measured as a reduction in the number of attacks while taking CINRYZE compared with placebo.

What could fewer HAE attacks mean for you or your child?

Talk to your doctor to see if preventive therapy with CINRYZE might be right for you or a loved one.

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