IGIV-C, a novel intravenous immunoglobulin: evaluation of safety, efficacy, mechanisms of action, and impact on quality of life. Thromb Haemost 2004 Apr;91(4):771-8
Date
03/27/2004Pubmed ID
15045139DOI
10.1160/TH03-10-0650Scopus ID
2-s2.0-11144354527 (requires institutional sign-in at Scopus site) 51 CitationsAbstract
The general safety and efficacy of intravenous immunoglobulin (IGIV) as treatment for idiopathic thrombocytopenic purpura (ITP) has been well-studied. The current study compares the safety and efficacy of a novel IGIV (IGIV-C; Gamunex, 10%) with a licensed solvent/detergent-treated product (IGIV-S/D; GamimuneN, 10%) in treatment of ITP. Ninety-seven pediatric and adult patients with acute and chronic ITP were treated in a multi-center, prospective, randomized, double-blind parallel group, non-inferiority trial at 26 international sites. Baseline data (age, duration of ITP, platelet counts, previous treatment) were comparable between groups. Patients were treated with 1 g/kg/day of IGIV-C or IGIV-S/D for 2 days. The primary end-point, proportion of patients whose platelet counts increased from >/=20 x 10(9)/L to >/=50 x 10(9)/L within 7 days after dosing, was achieved by 35/39 (90%) and 35/42 (83%) of patients treated with IGIV-C and IGIV-S/D, respectively. A secondary endpoint, maintaining platelet counts >/=50 x 10(9)/L for >/=7 days, was achieved by 29/39 (74%) of IGIV-C and 25/42 (60%) IGIV-S/D treated patients. Compared with IGIV-S/D, fewer patients treated with IGIV-C received corticosteroids beyond day 7 (p = 0.02). Efficacy was independent of the presence of isoantibodies or blood type, supporting mechanisms of effect different from anti-D treatments. Adverse events were generally mild and occurred with similar frequency in each group. Viral safety monitoring for HIV, HCV, HBV and Parvovirus B19 showed no seroconversions on study. In conclusion, IGIV-C is as safe and efficacious as IGIV-S/D in treatment of ITP.
Author List
Bussel JB, Eldor A, Kelton JG, Varon D, Brenner B, Gillis S, Angiolillo A, Kulkarni R, Abshire TC, Kelleher J, IGIV-C in ITP Study GroupMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Aged, 80 and over
Caprylates
Child
Child, Preschool
Double-Blind Method
Female
Humans
Immunoglobulins, Intravenous
Incidence
Infant
Male
Middle Aged
Platelet Count
Purpura, Thrombocytopenic, Idiopathic
Quality of Life
Sterilization
Treatment Outcome
Virus Diseases
