Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Fazekas, F; Lublin, FD; Li, D; Freedman, MS; Hartung, HP; Rieckmann, P; Sorensen, PS; Maas-Enriquez, M; Sommerauer, B; Hanna, K.
Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial.
Neurology. 2008; 71(4):265-271
Doi: 10.1212/01.wnl.0000318281.98220.6f
Web of Science
PubMed
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- Führende Autor*innen der Med Uni Graz
- Fazekas Franz
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- 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 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Central Nervous System - drug effects
- Disability Evaluation -
- Dose-Response Relationship, Drug -
- Double-Blind Method -
- Drug Administration Schedule -
- Female -
- Humans -
- Immunoglobulins, Intravenous - administration and dosage
- Immunotherapy - methods
- Infusions, Intravenous - adverse effects
- Male -
- Middle Aged -
- Multiple Sclerosis, Relapsing-Remitting - drug therapy
- Placebos -
- Recurrence - prevention and control
- Treatment Outcome -