The immunology of botulinum toxin therapy: A brief summary.

Like all proteins foreign to the human body, also botulinum toxin (BT) is antigenic and may stimulate an immune response with formation of antibodies (BT-AB). Affected patients may no longer respond to BT therapy and various degrees of BT-AB related therapy failure (ABF) may result. We want to review the immunological interactions between BT and BT-AB, the prevalence, the time course and the risk factors for BT-AB formation as they are related to the treatment algorithms, the patient's immune system and to exogenic factors. Special emphasis is placed on various features of the BT drugs including the specific biological activity (SBA) as a predictor of their antigenicity. Quantitative detection of BT-AB by the mouse diaphragm assay will be demonstrated. As ABF may have serious consequences for patients affected, careful risk factor analysis is warranted to reduce them wherever possible.