A comparison of native and modified intravenous immunoglobulin for the management of hypogammaglobulinemia.

Ten patients with severe hypogammaglobulinemia received 6 monthly infusions of either native or modified intravenous immunoglobulin (IVIG) followed by 6 monthly infusions of the other product in a double-blind, crossover protocol. Clinical parameters were monitored on a daily basis and serum was obtained at 24 hours, 3 weeks, and 4 weeks after each infusion for measurement of total IgG, specific antibodies, and opsonizing antibodies against Streptococcus pneumoniae types 5, 12F, and 14. No differences between the products were seen for total IgG or antibodies against herpes simplex virus types 1 and 2, rubella, toxoplasma cytomegalovirus, diphtheria, or tetanus. Greater opsonizing antibody to the three strains of pneumococci were apparent for native IVIG until the third infusion, after which time products were equal. Clinical parameters (febrile or symptomatic days, missed work/school, time on antibiotics, culture positive infection, and hospitalizations) were equivalent during the treatment period with each preparation. This study showed equivalent efficacy of native IVIG as compared with reduced and alkylated IVIG during maintenance therapy for hypogammaglobulinemia.