Trial reportAnnals of clinical and translational neurology2025
If it does not help, it might hurt: Pharmacodynamics of a second IVIg course in Guillain-Barré syndrome.
Trial report in Annals of clinical and translational neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Guillain-Barré Syndrome: Progress in Diagnosis, Biomarkers, Neuroimaging and Management.ImmunoTargets and therapy · 2026Review
- Assessing the impact of a second IVIG dose on patients with Guillain-Barré Syndrome: A synthesis without meta-analysis (SWiM).Qatar medical journal · 2025Review
- Plasma exchange following immunoglobulins for Guillain-Barré-Syndrome: a persisting problematic practice?Frontiers in neurology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
objectivesIntravenous immunoglobulin (IVIg) is an effective treatment for Guillain-Barré syndrome (GBS), but recovery varies between patients. This study aims to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of a single and a second IVIg dose (SID) in patients with GBS.
methodsData were analyzed from the SID-GBS trial, a double-blind, randomized, placebo-controlled study. Patients with poor prognosis (modified Erasmus GBS Outcome Score, mEGOS ≥6) after a standard course of IVIg (0.4 g/kg for 5 days) were randomized to receive either SID or placebo. Serum IgG levels were measured at standard serial time points and clinical outcomes were assessed using the GBS disability score and Medical Research Council sum score. PK modeling was performed to predict IVIg exposure and its association with clinical outcomes.
resultsSerum IgG concentration after a single and double course of IVIg was variable, but accurately described by the current PK model. Lower ΔIgG and IVIg exposure were associated with poorer clinical outcomes. SID increased the IgG concentration, but did not result in an improvement in clinical outcome. Serious adverse events, including thromboembolic events, occurred more frequently in the SID group and were associated with lower IVIg exposure.
interpretationSID increases serum IgG levels in GBS patients as predicted by the current PK model, but does not improve clinical outcomes and increases the risk of serious adverse events. Model-informed precision dosing may guide individualization of treatment.
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