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Second Intravenous Immunoglobulin Dose in Patients with Guillain-Barré Syndrome with Poor Prognosis (SID-GBS): A Double-Blind, Randomised, Placebo-Controlled Trial

By Currents Editor posted 06-30-2021 09:47

  

The Lancet Neurology (04/01/21)  DOI: 10.1016/S1474-4422(20)30494-4

Walgaard, Christa; Jacobs, Bart C; Lingsma, Hester F; et al.

https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(20)30494-4/fulltext 

New research finds no benefit but a risk of serious adverse events from a second intravenous immunoglobulin dose (SID) for patients with Guillain-Barré syndrome with a poor prognosis. Investigators had investigated the efficacy of a SID in this population, as treatment with one standard dose of I.V. immunoglobulin is not sufficient for some patients with severe Guillain-Barré syndrome. The randomized, double-blind study included patients with Guillain-Barré syndrome on their first day of standard I.V. immunoglobulin treatment (2 g/kg over 5 days). Using the modified Erasmus Guillain-Barré syndrome Outcome Score, patients with a poor prognosis score were randomized to receive SID or to placebo, 7-9 days after inclusion. Among the 93 patients with a poor prognosis who were included in the modified intention-to-treat analysis, 49 received SID and 44 received placebo. At 4 weeks, the adjusted common odds ratio for improvement on the Guillain-Barré syndrome disability score was 1.4. According to the data, more than twice as many patients who received a SID experienced serious adverse events in the first 30 days, including thromboembolic events, at 35% vs. 16% in the placebo group. In addition, four patients in the SID group died, 13-24 weeks after randomization. Based on the findings, the researchers say a SID should not be considered for the treatment of Guillain-Barré syndrome with a poor prognosis, and they call for more research into other immune modulators for these patients.

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