Gamunex was observed to have an acceptable safety profile in this study population. The effectiveness of Gamunex for treatment of GBS was comparable to PE therapy. Some 23 (21.1%) of 109 Gamunex-treated patients experienced ≥1 adverse event the profile and frequency were consistent with the adverse events reported for Gamunex in the product's labeling and with the natural clinical course of GBS. In the evaluable population of this study, Gamunex treatment was successful in 91.3% of patients (63/69). Cases were not evaluable if treatment success, relapse, or treatment failure could not be determined by the available chart data.Īpplying a conservative estimate with all nonevaluable patients (n= 40) classified as treatment failures, Gamunex treatment success was estimated at 57.8% (63 of 109 patients), which exceeded the predefined historical PE effectiveness threshold. Treatment success was assessed as ≥1 point improvement from baseline on the GBS Disability Scale or abbreviated GBS Disability Scale. The primary endpoint for assessing effectiveness was the proportion of patients with treatment success compared with a prospectively defined historical effectiveness threshold for plasma exchange (PE) treatment (55.05%). The study was conducted as a postapproval commitment for Health Canada.Ī medical chart review for hospitalized patients diagnosed with GBS and treated with Gamunex (Gamunex 10% and IGIVnex® 10% N=109 n=69 evaluable) was conducted at seven Canadian study centers in reverse chronological order. The objective of this retrospective study was to evaluate the effectiveness and safety of Gamunex® (immune globulin 10% hereinafter 'Gamunex') when administered intravenously in the initial treatment of Guillain-Barré syndrome (GBS).

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