By Antonella Macerollo
For May 2021, we have selected: Walgaard et al. Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial. Lancet Neurol 2021; 20=:275-283. doi: 10.1016/S1474-4422(20)30494-4.
Severe Guillain-Barré syndrome (GBS) is still a challenging condition in acute neurology practice. Treatment with one standard dose (2g/kg) of intravenous immunoglobulin is insufficient in cases with predicted poor outcome.
Our paper of the month is a randomised, double-blind, placebo-controlled trial (SID-GBS) testing whether a second intravenous immunoglobulin dose (SID) is effective in severe GBS.
The study included 327 patients with GBS, admitted to one of 59 participating hospitals in the Netherlands between Feb 2010 and June 2018.
Patients were included on the first day of standard intravenous immunoglobulin treatment (2g/kg over 5 days). Only patients with a score of ≥6 of the modified Erasmus Guillain-Barré syndrome Outcome Score (mEGBSOS) were randomly assigned to SID or to placebo.
The primary outcome measure was the Guillain-Barré syndrome disability score four weeks after inclusion.
Of the 327 patients, 112 had a score ≥6 of the mEGBSOS; 93/112 patients were included in the modified intention-to-treat analysis: 49 (53%) received SID and 44 (47%) received placebo.
Walgaard et al. found an adjusted common odds ratio for improvement on the Guillain-Barré syndrome disability score at four weeks equal to 1.4.
In the SID group, there were more serious adverse events (35% vs 16% in the first 30 days), including thromboembolic events, than those in the placebo group. Four patients died in the SID group (13–24 weeks after randomisation).
Our paper of the month did not provide evidence that patients with GBS with a poor prognosis benefit from a second intravenous immunoglobulin course; in fact, it was associated with a higher risk of serious adverse events. Therefore, a second intravenous immunoglobulin course should not be recommended for treatment of severe GBS cases. This study suggests a need to develop further studies on the effectiveness of other immunomodulant treatments (ie. Complement inhibitors and IgG degrading enzymes).