IGIV-C, a novel intravenous immunoglobulin: evaluation of safety, efficacy, mechanisms of action, and impact on quality of life

James B. Bussel; Amiram Eldor; John G. Kelton; David Varon; Benjamin Brenner; Shmuel Gillis; Anne Angiolillo; Roshni Kulkarni; Thomas C. Abshire; Jack Kelleher; the IGIV-C in ITP Study Group

doi:10.1160/TH03-10-0650

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2004; 91(04): 771-778
DOI: 10.1160/TH03-10-0650

Platelets and Blood Cells

Schattauer GmbH

IGIV-C, a novel intravenous immunoglobulin: evaluation of safety, efficacy, mechanisms of action, and impact on quality of life

Autor*innen

James B. Bussel

¹New York Presbyterian Hospital, New York, New York, USA
Amiram Eldor^†

²Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
John G. Kelton

³McMaster University Medical Centre, Hamilton, Ontario, Canada
David Varon

⁴Hadassah Hebrew University Medical Center, Jerusalem, Israel
Benjamin Brenner

⁵Rambam Medical Center, Haifa, Israel
Shmuel Gillis^†

⁴Hadassah Hebrew University Medical Center, Jerusalem, Israel
Anne Angiolillo

⁶Children’s National Medical Center, Washington, District of Columbia, USA
Roshni Kulkarni

⁷Michigan State University, East Lansing, Missouri, USA
Thomas C. Abshire

⁸Emory University, Atlanta, Georgia, USA
Jack Kelleher

⁹Bayer Corporation, West Haven, Connecticut, USA

the IGIV-C in ITP Study Group

Abstract

Summary

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; Gamimune®N, 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 endpoint, proportion of patients whose platelet counts increased from ≤20 × 10⁹/L to ≥50 × 10⁹/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 × 10⁹/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.

Keywords

IVIG - immunoglobulin - immunotherapy - viral safety

Volltext

Referenzen

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