Treatment of myasthenia gravis exacerbation with intravenous immunoglobulin: a randomized double-blind clinical trial.
BACKGROUND
The optimal dose of intravenous immunoglobulin (IVIG) in acute exacerbation of myasthenia gravis remains unknown. Increasing the treatment duration might provide added efficacy.


OBJECTIVE
To determine the optimal dose of IVIG for treating myasthenia gravis exacerbation.


METHODS
Randomized double-blind placebo-controlled multicenter trial designed to demonstrate superiority of the 2 g/kg dose over the 1 g/kg dose of IVIG, conducted between November 13, 1996, and October 26, 2002.


METHODS
One hundred seventy-three patients aged 15 to 85 years with acute exacerbation of myasthenia gravis.


METHODS
Participants were randomly assigned to receive 1 g/kg of IVIG on day 1 and placebo on day 2 (group 1) vs 1 g/kg of IVIG on 2 consecutive days (group 2).


METHODS
Improvement in the myasthenic muscular score after 2 weeks.


RESULTS
The mean improvements in the myasthenic muscular scores after 2 weeks were 15.49 points (95% confidence interval, 12.09-18.90 points) in group 1 and 19.33 points (95% confidence interval, 15.82-22.85 points) in group 2. However, the difference between the 2 groups was not significant (effect size, 3.84 [95% confidence interval, -1.03 to 8.71]; P = .12).


CONCLUSIONS
This trial found no significant superiority of 2 g/kg over 1 g/kg of IVIG in the treatment of myasthenia gravis exacerbation.
Gajdos
Philippe
P
Medical Intensive Care Unit, Raymond Poincaré Teaching Hospital, Assistance publique-Hôpitaux de Paris, Garches, France. mp.gajdos@9online.fr
Tranchant
Christine
C
Clair
Bernard
B
Bolgert
Francis
F
Eymard
Bruno
B
Stojkovic
Tanya
T
Attarian
Shahram
S
Chevret
Sylvie
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009157:Myasthenia Gravis / Q000628:therapy*; D009460:Neurologic Examination; D012189:Retrospective Studies; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
D016756:Immunoglobulins, Intravenous