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Inhibition of complement in Guillain-Barré syndrome: the ICA-GBS study.
- Source :
-
Journal of the peripheral nervous system : JPNS [J Peripher Nerv Syst] 2017 Mar; Vol. 22 (1), pp. 4-12. - Publication Year :
- 2017
-
Abstract
- The outcome of Guillain-Barré syndrome (GBS) remains unchanged since plasma exchange and intravenous immunoglobulin (IVIg) were introduced over 20 years ago. Pathogenesis studies on GBS have identified the terminal component of complement cascade as a key disease mediator and therapeutic target. We report the first use of terminal complement pathway inhibition with eculizumab in humans with GBS. In a randomised, double-blind, placebo-controlled trial, 28 subjects eligible on the basis of GBS disability grade of at least 3 were screened, of whom 8 (29%) were randomised. Five received eculizumab for 4 weeks, alongside standard IVIg treatment. The safety outcomes, monitored via adverse events capture, showed eculizumab to be well-tolerated and safe when administered in conjunction with IVIg. Primary and secondary efficacy outcomes in the form of GBS disability scores (GBS DS), MRC sum scores, Rasch overall disability scores, and overall neuropathy limitation scores are reported descriptively. For the primary efficacy outcome at 4 weeks after recruitment, two of two placebo- and two of five eculizumab-treated subjects had improved by one or more grades on the GBS DS. Although the small sample size precludes a statistically meaningful analysis, these pilot data indicate further studies on complement inhibition in GBS are warranted.<br /> (© 2016 Peripheral Nerve Society.)
- Subjects :
- Adult
Aged
Disability Evaluation
Dose-Response Relationship, Drug
Double-Blind Method
Female
Gangliosidoses, GM2 metabolism
Gangliosidosis, GM1 metabolism
Humans
Longitudinal Studies
Male
Middle Aged
Treatment Outcome
Antibodies, Monoclonal, Humanized therapeutic use
Guillain-Barre Syndrome drug therapy
Immunologic Factors therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1529-8027
- Volume :
- 22
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of the peripheral nervous system : JPNS
- Publication Type :
- Academic Journal
- Accession number :
- 27801990
- Full Text :
- https://doi.org/10.1111/jns.12194