Mult Scler. 2004 Feb;10(1):89-91
Visser LH, Beekman R, Tijssen CC, Uitdehaag BM, Lee ML, Movig KL, Lenderink AW.
Department of Neurology, St. Elisabeth Hospital, Tilburg, The Netherlands
Some patients with multiple sclerosis (MS) do not show a clear improvement of acute relapses after treatment with intravenous methylprednisolone (IVMP).
We compared the efficacy of the combination of intravenous immunoglobulins (IVIg) and IVMP with the standard treatment of IVMP alone in promoting recovery from moderate to severe acute relapses in MS.
Patients with clinically definite MS having a relapse with at least a one point increase in Kurtzke's expanded disability status scale (EDSS) in comparison to the preattack EDSS were randomized to IVMP-IVIg or IVMP-placebo treatment.
The primary outcome criterion was the EDSS grade at four weeks.
A preplanned interim analysis was performed after inclusion of 19 consecutive MS patients to evaluate the sample size necessary for a larger trial.
Both groups had improved one point on the EDSS four weeks after start of treatment (P = 0.81) and one of the stopping rules of the interim analysis was fulfilled.
There were also no differences in secondary outcomes:
Our study could not show superiority of IVMP-IVIg in the treatment of moderate to severe acute relapses in MS.