Profile of Xeomin® (incobotulinumtoxinA) for the treatment of blepharospasm

Abstract

Even though conventional botulinum neurotoxin (BoNT) products have shown successful treatment results in patients with benign blepharospasm (BEB), the main, potential long-term side effect of BoNT use is the development of immunologic resistance due to the production of neutralizing antibody to the neurotoxin after repeated injections. Xeomin® (incobotulinumtoxinA), a unique botulinum neurotoxin type A (BoNT/A) drug free of complexing proteins otherwise contained in all conventional BoNT/A drugs, was recently approved by US Food and Drug Administration for the treatment of cervical dystonia or blepharospasm in adults. The newly approved BoNT/A drug may overcome this limitation of previous conventional products, since it contains pure neurotoxin (150 kDa) through a manufacturing process that separates it from complexing proteins such as hemagglutinins produced by fermentation of Clostridium botulinum. Many studies have also shown that Xeomin® has the same efficacy and safety profile as complexing protein-containing products such as Botox® and is exchangeable with Botox® using a simple 1:1 conversion ratio. Xeomin® represents a new treatment option for the repeated treatment of patients with blepharospasm in that it may reduce antibody-induced therapy failure. But, long-term comparative trials in naïve patients between Xeomin® and conventional BoNT/A drugs are required to confirm the low immunogenicity of Xeomin®.

British Neurotoxin Network recommendations for managing cervical dystonia in patients with a poor response to botulinum toxin

“…Recent studies show relatively low rates of neutralising antibodies with using botulinum toxin-A, 12 and that these antibodies are not closely associated with treatment failure. Rates of treatment failure associated with neutralising antibodies with Dysport range from 0% 10 to 2.5%, 4 with Xeomin range from 0% 13 to 1% in patients who had previously received other botulinum toxin-A products, 14 and with Botox from 0% 13 to 1.2%. 16 …”

Conversion ratio between different botulinum neuroprotein product in neurological practice

“…Диффузия осуществляется до момента установления равновесной концентрации (кинетическая дисперсия). Степень диффузии токсина зависит от дозы, объема, концентрации введенного препарата [36][37][38][39].…”

“…Частота образования антител при применении БТА по неврологическим показаниям, по данным различных клинических исследований, составляет 1,2-2,2% для онаботулотоксина А (ботокс) [34,44], 1,8% для абоботулотоксина А (диспорт) [44], 1,1% для инкоботулотксина А (ксеомин) [37]. То есть все препараты БТА обладают низким уровнем иммуногенности, статистически достоверной разницы в формировании нейтрализующих антител между препаратами БТА не выявлено.…”

Evaluating botulinum toxin products for clinical use requires accurate, complete, and unbiased data

“…Xeomin ® is stated as “being obtained from the same strain of Clostridium botulinum as Botox ® ” 4. This is incorrect.…”

“…One factor of product comparison that Park and colleagues4 have used is the amount of BoNT protein that would be injected for each product as used in therapy. This is designated the “protein load” of the product, presented as nanograms (ng) per vial 18.…”