Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial 28 July 2008
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.
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.
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.
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.
Fazekas F, Lublin FD, Li D, Freedman MS, Hartung HP, Rieckmann P, Sørensen PS, Maas-Enriquez M, Sommerauer B, Hanna K; PRIVIG Study Group; UBC MS/MRI Research Group.
Rice G, Duquette P, Freedman MS, Panitch H, Coyle P, Vollmer T, Jefferey D, Strasser-Fuchs S, Rektor I, Stourac P, Havrdová E, Meluzínová E, Haas J, Hartung HP, Wolfgang H, Oschmann P, Kiefer R, Haller P, Tumani H, Gold R, Papadimitriou A, Komoly S, Jakab G, Harcos P, Vécsei L, Miller A, Wajgt A, Selmaj K, Stelmasiak Z, Kotowicz J, Constantinescu C, Cheng Y, Faber R, Han J, Lagroix L, Li D, Medina M, Riddehough A, Traboulsee A, To A, Yu R, Zhao G.
Department of Neurology, Medical University of Graz, Auenbruggerplatz 22, A-8036 Graz, Austria.
Source: Neurology. 2008 Jul 22;71(4):265-71