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Intravenous immunoglobulin in relapsing-remitting multiple sclerosis

A dose-finding trial

From the Medical University of Graz (F.F.), Austria; The Mount Sinai School of Medicine (F.D.L.), New York, NY; University of British Columbia and UBC Hospital (D.L.), Vancouver, Canada; The Ottawa Hospital–General Campus (M.S.F.), Ottawa, Canada; Heinrich-Heine-Universität (H.P.H.), Düsseldorf, Germany; Neurologische Universitätsklinik (P.R.), Würzburg, Germany; Copenhagen University Hospital Rigshospitalet (P.S.S.), Copenhagen, Denmark; Bayer HealthCare AG (M.M.-E.), Leverkusen, Germany; Bayer Vital GmbH (B.S.), Leverkusen, Germany; and Talecris Biotherapeutics (K.H.), Research Triangle Park, NC.

Address correspondence and reprint requests to Dr. Franz Fazekas, Department of Neurology, Medical University of Graz, Auenbruggerplatz 22, A-8036 Graz, Austria franz.fazekas{at}meduni-graz.at

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 IVIG- and placebo-treated groups. After 1 year, the proportion of relapse-free patients did not differ statistically according to treatment (IVIG 0.2 g/kg: 57%; IVIG 0.4 g/kg: 60%; placebo: 68%), and there was no difference regarding the cumulative number of unique newly active MRI lesions (median numbers: IVIG 0.2 g/kg: 8.0; IVIG 0.4 g/kg: 5.0; placebo: 7.2) after 48 weeks. There were no significant between-group differences in the rates of adverse events.

Conclusion: Although IV immunoglobulin (IVIG) treatment was well tolerated, this study did not substantiate a beneficial effect of IVIG in doses ranging from 0.2 to 0.4 g/kg. This result seriously questions the utility of IVIG for the treatment of relapsing-remitting multiple sclerosis.

Abbreviations: AE = adverse event; EDSS = Expanded Disability Status Scale; ESIMS = European Study of Immunoglobulins in Secondary Progressive Multiple Sclerosis; GA = glatiramer acetate; Gd = gadolinium; IFN-β = interferon β; IVIG = IV immunoglobulin; MS = multiple sclerosis; MSFC = Multiple Sclerosis Functional Composite; PRIVIG = Prevention of Relapse with Intravenous Immunoglobulin; RRMS = relapsing-remitting multiple sclerosis.

*The PRIVIG Study Group and the UBC MS/MRI Research Group are listed in the appendix.

Supported by Bayer HealthCare AG (Leverkusen, Germany).

Disclosure: Author disclosures are provided at the end of the article.

Received September 14, 2007. Accepted in final form April 2, 2008.

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