Abstract
The objective of this retrospective study was to evaluate the effectiveness and safety of Gamunex® (immune globulin [human] 10%; hereinafter "Gamunex") when administered intravenously in the initial treatment of Guillain-Barré syndrome (GBS). The study was conducted as a postapproval commitment for Health Canada. A 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 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%). Treatment success was assessed as ≥1 point improvement from baseline on the GBS Disability Scale or abbreviated GBS Disability Scale. Cases were not evaluable if treatment success, relapse, or treatment failure could not be determined by the available chart data. Applying 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. In the evaluable population of this study, Gamunex treatment was successful in 91.3% of patients (63/69). 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. The effectiveness of Gamunex for treatment of GBS was comparable to PE therapy. Gamunex was observed to have an acceptable safety profile in this study population.
Highlights
Guillain-Barré syndrome (GBS) is a rare but potentially life-threatening disease with an incidence of 1.11 per 100,000 person-years.[1]
A total of 123 hospitalized patients diagnosed with GBS (109 Gamunex-treated and 14 plasma exchange (PE)-treated) were assessed via retrospective medical chart review (Figure 1)
If the GBS Disability Scale was missing, the abbreviated GBS Disability Scale was used. aA success rate of 55.05% among Gamunex-treated patients (90% of the historical PE success rate of 56.7%) was considered adequate effectiveness. bCases were nonevaluable if treatment success, relapse, or treatment failure could not be determined by the available chart data
Summary
Guillain-Barré syndrome (GBS) is a rare but potentially life-threatening disease with an incidence of 1.11 per 100,000 person-years.[1]. Exchange (PE).[12,13,14] For the past decade, the use of IVIg has largely replaced PE as the treatment of choice for GBS due to its treatment effect being similar to that of PE, its convenience in administration, and its good safety profile. The objective of this retrospective study was to evaluate the effectiveness and safety of Gamunex® (immune globulin [human] 10%; hereinafter “Gamunex”) when administered intravenously in the initial treatment of Guillain-Barré syndrome (GBS). Gamunex was observed to have an acceptable safety profile in this study population
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