A randomised controlled trial of intravenous immunoglobulin in IgM paraprotein associated demyelinating neuropathy.
This multicentre randomised double blind crossover trial tested the short term efficacy of intravenous immunoglobulin (IVIg) 2.0 g/kg given over 24 or 48 hours in patients with paraproteinaemic demyelinating neuropathy (PDN). Twenty-two patients were randomised and completed the trial. After 2 weeks, the overall disability grade decreased during both IVIg treatment and placebo but neither change was significant nor was the mean difference between the treatment effects. After 4 weeks the overall disability decreased by a mean of 0.55 [0.67] grades during the IVIg period (p = 0.001) while it was substantially unmodified during the placebo period. The mean difference between the treatment effects was significant (p = 0.05). Overall during the IVIg period 10 patients improved and 11 were stable and one got worse. During the placebo period 4 patients improved, 4 deteriorated and 14 were stable. Many secondary outcome measures, including Rankin scale, time to walk 10 metres, grip strength, sensory symptoms score were significantly better during IVIg treatment. Two serious adverse events occurred during the trial, both during placebo treatment. In conclusion the trial showed some short-term benefit of IVIg in about half of the patients confirming previous observation.
Comi
Giancarlo
G
Department of Neurology, Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. g.comi@hsr.it
Roveri
Luisa
L
Swan
Antony
A
Willison
Hugh
H
Bojar
Martin
M
Illa
Isabel
I
Karageorgiou
Clementine
C
Nobile-Orazio
Eduardo
E
van den Bergh
Peter
P
Swan
Tony
T
Hughes
Richard
R
Aubry
Jaques
J
Baumann
Nicole
N
Hadden
Robert
R
Lunn
Michael
M
Knapp
Martin
M
Léger
Jean-Marc
JM
Bouche
Pierre
P
Mazanec
Radim
R
Meucci
Nicoletta
N
van der Meché
Frans
F
Toyka
Klaus
K
D000368:Aged; D018592:Cross-Over Studies; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007075:Immunoglobulin M / Q000276:immunology; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008297:Male; D010265:Paraproteinemias / Q000188:drug therapy / Q000276:immunology; D011129:Polyradiculoneuropathy / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome
D007075:Immunoglobulin M; D016756:Immunoglobulins, Intravenous