Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial

F. Fazekas; F.D. Lublin; D. Li; M.S. Freedman; H.P. Hartung; P. Rieckmann; P.S. Sorensen; B. Sommerauer; K. Hanna; Per Soelberg Sørensen

Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial

F. Fazekas, F.D. Lublin, D. Li, M.S. Freedman, H.P. Hartung, P. Rieckmann, P.S. Sorensen, B. Sommerauer, K. Hanna, Per Soelberg Sørensen

90 Citations (Scopus)

Abstract

OBJECTIVE: Several studies have reported a reduction of relapses after the long-term administration of IV immunoglobulin (IVIG) to patients with relapsing-remitting multiple sclerosis (RRMS), but they were mostly small and differed in terms of predefined outcome variables and treatment regimen. We therefore set out to test two different doses of a new formulation of immunoglobulin termed IGIV-C 10% for suppression of both clinical and MRI disease activity as well as safety. METHODS: One hundred twenty-seven patients with RRMS participated in this multicenter, randomized, double-blind, placebo-controlled trial. Forty-four and 42 patients received treatment with 0.2 and 0.4 g/kg of IGIV-C 10%, and 41 patients received an equal volume of placebo (0.1% albumin) every 4 weeks for 48 weeks. The primary endpoint was the proportion of relapse-free patients. The main secondary endpoint was lesion activity assessed by 6-weekly MRI. RESULTS: Baseline variables were similar in
Udgivelsesdato: 2008/7/22

Original language	English
Journal	Neurology
Volume	71
Issue number	4
Pages (from-to)	265-271
Number of pages	6
ISSN	0028-3878
Publication status	Published - 2008

Cite this

@article{2e632400986d11de8bc9000ea68e967b,

title = "Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial",

abstract = "OBJECTIVE: Several studies have reported a reduction of relapses after the long-term administration of IV immunoglobulin (IVIG) to patients with relapsing-remitting multiple sclerosis (RRMS), but they were mostly small and differed in terms of predefined outcome variables and treatment regimen. We therefore set out to test two different doses of a new formulation of immunoglobulin termed IGIV-C 10% for suppression of both clinical and MRI disease activity as well as safety. METHODS: One hundred twenty-seven patients with RRMS participated in this multicenter, randomized, double-blind, placebo-controlled trial. Forty-four and 42 patients received treatment with 0.2 and 0.4 g/kg of IGIV-C 10%, and 41 patients received an equal volume of placebo (0.1% albumin) every 4 weeks for 48 weeks. The primary endpoint was the proportion of relapse-free patients. The main secondary endpoint was lesion activity assessed by 6-weekly MRI. RESULTS: Baseline variables were similar in Udgivelsesdato: 2008/7/22",

author = "F. Fazekas and F.D. Lublin and D. Li and M.S. Freedman and H.P. Hartung and P. Rieckmann and P.S. Sorensen and B. Sommerauer and K. Hanna and S{\o}rensen, {Per Soelberg}",

year = "2008",

language = "English",

volume = "71",

pages = "265--271",

journal = "Neurology",

issn = "0028-3878",

publisher = "Lippincott Williams & Wilkins",

number = "4",

}

TY - JOUR

T1 - Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial

AU - Fazekas, F.

AU - Lublin, F.D.

AU - Li, D.

AU - Freedman, M.S.

AU - Hartung, H.P.

AU - Rieckmann, P.

AU - Sorensen, P.S.

AU - Sommerauer, B.

AU - Hanna, K.

AU - Sørensen, Per Soelberg

PY - 2008

Y1 - 2008

N2 - OBJECTIVE: Several studies have reported a reduction of relapses after the long-term administration of IV immunoglobulin (IVIG) to patients with relapsing-remitting multiple sclerosis (RRMS), but they were mostly small and differed in terms of predefined outcome variables and treatment regimen. We therefore set out to test two different doses of a new formulation of immunoglobulin termed IGIV-C 10% for suppression of both clinical and MRI disease activity as well as safety. METHODS: One hundred twenty-seven patients with RRMS participated in this multicenter, randomized, double-blind, placebo-controlled trial. Forty-four and 42 patients received treatment with 0.2 and 0.4 g/kg of IGIV-C 10%, and 41 patients received an equal volume of placebo (0.1% albumin) every 4 weeks for 48 weeks. The primary endpoint was the proportion of relapse-free patients. The main secondary endpoint was lesion activity assessed by 6-weekly MRI. RESULTS: Baseline variables were similar in Udgivelsesdato: 2008/7/22

AB - OBJECTIVE: Several studies have reported a reduction of relapses after the long-term administration of IV immunoglobulin (IVIG) to patients with relapsing-remitting multiple sclerosis (RRMS), but they were mostly small and differed in terms of predefined outcome variables and treatment regimen. We therefore set out to test two different doses of a new formulation of immunoglobulin termed IGIV-C 10% for suppression of both clinical and MRI disease activity as well as safety. METHODS: One hundred twenty-seven patients with RRMS participated in this multicenter, randomized, double-blind, placebo-controlled trial. Forty-four and 42 patients received treatment with 0.2 and 0.4 g/kg of IGIV-C 10%, and 41 patients received an equal volume of placebo (0.1% albumin) every 4 weeks for 48 weeks. The primary endpoint was the proportion of relapse-free patients. The main secondary endpoint was lesion activity assessed by 6-weekly MRI. RESULTS: Baseline variables were similar in Udgivelsesdato: 2008/7/22

M3 - Journal article

SN - 0028-3878

VL - 71

SP - 265

EP - 271

JO - Neurology

JF - Neurology

IS - 4

ER -