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Japanese multicenter clinical trial of intravenous polyethylene glycol‐treated immunoglobulin and comparison with previous clinical trial of sulfonated immunoglobulin in Guillain–Barré syndrome
Author(s) -
Nomura Kyoichi,
Kusunoki Susumu
Publication year - 2017
Publication title -
clinical and experimental neuroimmunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.297
H-Index - 15
ISSN - 1759-1961
DOI - 10.1111/cen3.12407
Subject(s) - medicine , adverse effect , peg ratio , antibody , interquartile range , guillain barre syndrome , clinical trial , gastroenterology , polyethylene glycol , immunology , chemistry , organic chemistry , finance , economics
Objective In Japan, freeze‐dried sulfonated human immunoglobulin is indicated for the treatment of patients with Guillain–Barré syndrome ( GBS ), and the efficacy and safety of this intravenous immunoglobulin treatment is well established. However, the efficacy and safety of freeze‐dried polyethylene glycol‐treated human immunoglobulin ( PEG ‐Ig; Kenketsu Glovenin‐I) in patients with GBS remains unclear. In the present study, we therefore evaluated the efficacy and safety of treatment with PEG ‐Ig in patients with GBS . Methods We carried out a multicenter, open‐label, single‐arm Japanese clinical trial to verify the efficacy and safety of treatment with PEG ‐Ig in patients with GBS . Results The percentage of patients who improved one grade on the Hughes’ functional grading scale after 4 weeks (primary outcome) of treatment with PEG ‐Ig was 65.0% (95% confidence interval 40.8–84.6). The median period required for the one‐grade functional grading improvement after treatment with PEG ‐Ig was 15.0 days (interquartile range 8.5–33.0 days). Although the incidence of adverse drug reactions to PEG ‐Ig treatment was 72.7%, none of the adverse reactions was serious. Conclusions The results of the present study confirmed that treatment with PEG ‐Ig was as therapeutically useful as treatment with sulfonated human immunoglobulin in patients with GBS .