Clinical trial of sulfonated immunoglobulin preparation for intravenous administration. I. Replacement therapy for primary immunodeficiency syndromes.

S-sulfonated gamma-globulin (GGS), derived from human gamma-globulin by selective sulfonation, retains the dimensional structure and antibody activity of 7S gamma-globulin. GGS does not bind with complement, and is therefore suitable for intravenous administration. Fc activity is recovered through in vivo conversion to intact globulin following IV administration. A total of 414 administrations of GGS was made to 48 patients with primary immunodeficiency syndrome. The frequency of episodes of fever, cough, and infections suffered by those patients who had been treated with other globulin preparations for about one year before the administration of GGS was compared with that following replacement GGS therapy for about one year. Symptomatic relief on administration of GGS was confirmed to be excellent. The administration of 100 mg/kg/BW of GGS resulted in the IgG level rising to 220 mg/dl, with a decrease to 100 mg/dl after one week. The IgG level at two weeks was 70 mg/dl. It is possible to maintain an IgG level of 200 mg/dl by administration of 100 mg/kg/BW of GGS once every 3-4 weeks.