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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

James B. Bussel
1   New York Presbyterian Hospital, New York, New York, USA
,
Amiram Eldor   †
2   Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
,
John G. Kelton
3   McMaster University Medical Centre, Hamilton, Ontario, Canada
,
David Varon
4   Hadassah Hebrew University Medical Center, Jerusalem, Israel
,
Benjamin Brenner
5   Rambam Medical Center, Haifa, Israel
,
Shmuel Gillis   †
4   Hadassah Hebrew University Medical Center, Jerusalem, Israel
,
Anne Angiolillo
6   Children’s National Medical Center, Washington, District of Columbia, USA
,
Roshni Kulkarni
7   Michigan State University, East Lansing, Missouri, USA
,
Thomas C. Abshire
8   Emory University, Atlanta, Georgia, USA
,
Jack Kelleher
9   Bayer Corporation, West Haven, Connecticut, USA
,
the IGIV-C in ITP Study Group › Author AffiliationsFinancial support: This work was supported by Bayer HealthCare as part of the clinical development of Gamunex.
Further Information

Publication History

Received 26 October 2003

Accepted after revision 02 January 2004

Publication Date:
06 December 2017 (online)

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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

† Dr. Shmuel Gillis was tragically killed in a terrorist attack on his way home from Hadassah Hospital on February 1, 2001. Professor Amiram Eldor was tragically killed in a plane crash on November 24, 2001. This manuscript is dedicated in their names


 

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