Intravenous immunoglobulin treatment following the first demyelinating event suggestive of multiple sclerosis: a randomized, double-blind, placebo-controlled trial.
BACKGROUND
Intravenous immunoglobulin (IVIg) has been reported to reduce disease activity in patients with relapsing-remitting multiple sclerosis. We assessed the effect of IVIg treatment in patients after the first neurological event suggestive of demyelinative disease and evaluated the occurrence of a second attack and dissemination in time demonstrated by brain magnetic resonance imaging within the first year from onset.


METHODS
We conducted a randomized, placebo-controlled, double-blind study in 91 eligible patients enrolled within the first 6 weeks of neurological symptoms. Patients were randomly assigned to receive IVIg treatment (2-g/kg loading dose) or placebo, with boosters (0.4 g/kg) given once every 6 weeks for 1 year. Neurological and clinical assessments were done every 3 months, and brain magnetic resonance imaging was performed at baseline and the end of the study.


RESULTS
The cumulative probability of developing clinically definite multiple sclerosis was significantly lower in the IVIg treatment group compared with the placebo group (rate ratio, 0.36 [95% confidence interval, 0.15-0.88]; P = .03). Patients in the IVIg treatment group had a significant reduction in the volume and number of T2-weighted lesions and in the volume of gadolinium-enhancing lesions as compared with the placebo group (P = .01, P = .01, and P = .03, respectively). Treatment was well tolerated, compliance was high, and incidence of adverse effects did not differ significantly between groups.


CONCLUSIONS
Intravenous immunoglobulin treatment for the first year from onset of the first neurological event suggestive of demyelinative disease significantly lowers the incidence of a second attack and reduces disease activity as measured by brain magnetic resonance imaging.
Achiron
Anat
A
Multiple Sclerosis Center and Neuroradiology Unit, Sheba Medical Center, Tel-Hashomer 52621, Israel. achiron@post.tau.ac.il
Kishner
Irena
I
Sarova-Pinhas
Ida
I
Raz
Havi
H
Faibel
Meir
M
Stern
Yael
Y
Lavie
Mor
M
Gurevich
M
M
Dolev
Mark
M
Magalashvili
David
D
Barak
Yoram
Y
D000328:Adult; D001921:Brain / Q000473:pathology; D003711:Demyelinating Diseases / Q000150:complications / Q000473:pathology / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005682:Gadolinium; D006801:Humans; D007116:Immunization, Passive; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000209:etiology / Q000473:pathology / Q000628:therapy*; D016017:Odds Ratio; D013997:Time Factors; D016896:Treatment Outcome
D016756:Immunoglobulins, Intravenous; D005682:Gadolinium