GAMMAGARD LIQUID Clinical Trials: Primary Immunodeficiency (PI)
- Sustained efficacy for IVIG
- Sustained efficacy for SCIG
- Study designs
Sustained efficacy with intravenous immune globulin (IVIG) treatment
In the IV administration clinical trial, GAMMAGARD LIQUID provided sustained protection against infection with1,2:
0
zero validated acute serious bacterial infections (ASBIs)*†
0
zero hospitalizations secondary to validated bacterial infections
4
four validated other bacterial infections‡
*The rate of validated ASBIs (95% CI 0.000, 0.064; P<0.0001) was significantly lower than the rate of <1 per patient per year which was set by the FDA.
†Validated ASBIs include bacteremia∕sepsis, bacterial meningitis, osteomyelitis∕septic arthritis, bacterial pneumonia, and visceral abscess.
‡Validated other bacterial infections included 1 urinary tract infection, 1 gastroenteritis, and 2 otitis media. The rate of all clinically-defined but nonvalidated infections was 3.4 infections per patient per year (n=61).
Sustained efficacy with subcutaneous IG (SCIG) treatment
In the SC administration clinical trial, GAMMAGARD LIQUID provided sustained protection against infection with1,3:
0.067
annual rate of ASBIs per patient per year was 0.067§
Three serious validated bacterial pneumonia cases.
0
zero infection-related hospitalizations per patient per year
4
four days of missed work/
school or days unable to
perform normal activities per patient per year∥
Total number of subject years was 44.
§The rate of validated ASBIs (0.067, upper 99% confidence limit of 0.133; P<0.0001) was significantly lower than the rate of <1 per patient per year which was set by the FDA.
∥ 95% CI 2.5 to 6.1.
Study designs
GAMMAGARD LIQUID was studied for IVIG use during a phase 3, multicenter clinical trial of 61 patients with PI. Patients in this trial received a total of 1,812 infusions. Infusions were administered at a dose of 300 to 600 mg/kg every 21 to 28 days for 12 months.1,2
GAMMAGARD LIQUID was studied for weekly subcutaneous IG (SCIG) use for treatment of PI in a prospective, open-label, non-controlled, multicenter study of 47 patients who received a total of 2,294 infusions. Patients who were receiving a minimum of 300 mg/kg of IG for at least 3 months were eligible for the study.1,3
- Patients in this trial received IVIG 10% every 3 or 4 weeks for 13 weeks before transitioning to SCIG.1,3
- Patients received infusions of GAMMAGARD LIQUID SC 1 week after their last IVIG treatment. The SCIG treatment was dosed at 130% of the IVIG weekly equivalent dose for 12 weeks, followed by infusions at 137% of the IVIG weekly equivalent dose for 6 weeks.1,3
The primary outcome measure for both the IVIG and the SCIG trial was annual rate of acute serious bacterial infections (ASBIs); the annual rate definition was the mean number of ASBIs per patient per year.1-3
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