GammaplexImmune Globulin Intravenous
(Human), 5% Liquid

Efficacy of
Gammaplex

 

Proven efficacy in PI (primary immunodeficiency disease) - Study design

A prospective, open-label, single-arm, multicenter, phase III study¹

  • 50 patients who had been receiving IGIV replacement therapy for at least 3 months prior to the start of the study were recruited
  • Patients received Gammaplex at individually adjusted doses ranging from 279 mg/kg to 799 mg/kg for 12 months
    • Infusions were delivered every 3 to 4 weeks
  • Infusions were started at a rate of 0.1 mL/kg/min and could be gradually increased up to a defined maximum rate of 0.08 mL/kg/min every fifteen minutes1
  • The primary objective was to demonstrate that the rate of serious acute bacterial infections (SABIs) was less than 1 per patient per year

Study results

  • The annual rate of SABIs per patient was 0.0, with an upper one-sided 99% confidence interval of 0.101
    • This was clearly below the predefined threshold of 1.0 mandated by the FDA
  • When all infections were considered, the annual rate of infection per subject was 3.07
    • This is consistent with published reports of other IGIV products

Proven efficacy in chronic ITP (immune thrombocytopenic purpura) - Study design

A prospective, open-label, single-arm, multicenter study assessed the efficacy of Gammaplex in chronic ITP2.

  • The study was performed in 35 patients with chronic ITP
    • Each subject had a platelet count of ≤20 x 109/L
    • 9 of subjects were male and 26 were female
  • Patients received a cumulative 2 g/kg dose of Gammaplex administered as 1 g/kg/day for two consecutive days
  • Patients were monitored for 90 days
  • The primary endpoint was the percentage of patients with an increase in platelet counts to at least 50 x 109/L within 9 days after the first infusion (responders)

Study results

Of the 35 patients in the efficacy analysis:

  • 29 (82.9%) responded to Gammaplex with a rise in platelet counts to at least 50 x 109/L
  • The one-sided 97.5% lower confidence interval for the response rate (66.4%) was above the predefined response rate of 60%

For additional product-related medical information, contact Bio Products Laboratory Medical Affairs at 1-800-504-5434

*Defined as pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.

Please see Important Safety Information and full prescribing information.

 

1. Moy J N, Scharenberg AM, Stein MR, et al. Efficacy and safety of a new immunodeficiency disease. Clin Exp Immunol 2010; 162: 510-515.
2. Gammaplex Prescribing Information, 2014 VSUS5PI

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