Second Intravenous Immunoglobulin Dose Not Suggested for Severe Guillain-Barré Syndrome
Patients with severe Guillain-Barré syndrome do not benefit from a second intravenous immunoglobulin dose, according to a study published in The Lancet Neurology.
About 25% of patients with Guillain-Barré syndrome and a poor prognosis worldwide receive a second intravenous immunoglobin dose but it has not been proven effective.
“We aimed to investigate whether a [second intravenous immunoglobin dose]SID is effective in patients with Guillain-Barré syndrome with a predicted poor outcome,” wrote Christa Walgaard, MD, Erasmus MC University Medical Center, Rotterdam, Netherlands, and co-investigators.
In a double-blind, randomized, and placebo-controlled trial, researchers enrolled patients with Guillain-Barré syndrome aged 12 and older with a poor prognosis between February 2010 and June 2018. A total of 327 patients across 59 hospitals in the Netherlands were ultimately included in the study while receiving standard intravenous immunoglobulin treatment. Of 112 patients with a poor prognosis, 93 patients were included in the modified intention-to-treat analysis.
Using block randomization stratified by centre, 49 patients (53%) with poor prognosis received a second intravenous immunoglobin dose while 44 (47%) received placebo.
The primary endpoint was the Guillain-Barré syndrome disability score 4 weeks after inclusion.
Researchers found the adjusted common odds ratio for improvement on Guillain-Barré syndrome disability score was 1.4 (95% CI 0.6–3.3; P=0.45) at 4 weeks.
Patients given the second intravenous immunoglobin dose had more serious adverse events than the placebo arm. Four patients died in the 13-24 weeks following randomization.
These results provided no evidence that a second intravenous immunoglobin dose was beneficial for patients with Guillain-Barré syndrome with poor prognosis and indicated that the additional dose puts patients at risk of serious adverse events.
Researchers do not suggest a second intravenous immunoglobulin dose be considered for treatment of severe Guillain-Barre syndrome.
“The results indicate the need for treatment trials with other immune modulators in patients severely affected by Guillain-Barré syndrome,” concluded Dr Walgaard et al. —Erin McGuinness