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The immunology of BTX

The immunology of BTX

Neutralizing antibodies against BTX can decrease or abolish clinical efficacy of the treatment. The development of these antibodies correlates with total antigen load,

defined as the combined amount of neurotoxin product, complexing proteins, and residual proteins. A higher total antigen load increases the risk of antibody development. For example, ONA was originally formulated with a total antigen load of 25 ng per 100 units which was subsequently reduced to 5 ng per 100 units. Patients treated with the original formulation (prior to 1998) were six times more likely to have neutralizing antibodies than those who received the newer formulation.21 Of the three FDA-approved BTX type A formulations currently available, INCO has the lowest total antigen load at 0.44 ng per 100 units.22 However, due to the small total antigen loads in all current formulations, the clinical relevance of this distinction is unknown.