Gammaked Background

Clinical PI Information

IN A PI STUDY (IV ADMINISTRATION) GAMMAKEDTM DEMONSTRATED PROVEN EFFICACY VS A 10% LIQUID IGIV-S/D COMPARATOR1*

Double-blind, parallel group, multicenter, therapeutic equivalence trials of 172 patients with PI (95% with common variable immunodeficiency [CVID] or hypogammaglobulinemia) randomized to receive Gammaked or Gamimune N, 10% [Immune Globulin Intravenous (Human)].

  • No validated cases of pneumonia1
  • Significantly fewer cases of validated and clinically defined acute sinusitis (P = 0.012)1
  • The number of patients with at least 1 validated infection during the 9-month study period was 9 (12%) for Gammaked and 17 (23%) for Gamimune N, 10% (P = 0.06 [NS])1
*Gammaked vs Gamimune N, 10% [Immune Globulin Intravenous (Human)].

Reference1. Roifman CM, Schroeder H, Berger M, et al, and the IGIV-C in PID Study Group. Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency: a randomized double-blind trial. Int Immunopharmacol. 2003;3:1325-1333.