Aktuelle Neurologie 2005; 32 - P377
DOI: 10.1055/s-2005-919411

Low rate of neutralising antibody formation to botulinum toxin type A in the course of treatment of primary axillary hyperhidrosis

M Naumann 1, H Hamm 1, D Glaser 1, S Daggett 1, C Kumar 1, Y Weng 1, M Brin 1
  • 1Augsburg, Wurzburg; Saint Louis, Irvine, USA; High Wycombe, UK

Background: Hyperhidrosis is excessive sweating beyond that required to return body temperature to normal. Treatment of hyperhidrosis with botulinum toxin type A (BoNTA: BOTOX®, Allergan, Inc.) injections has been shown to be effective and well-tolerated. The development of neutralizing antibodies that interfere with clinical effectiveness is a risk of repeated exposure to BoNTA. Several factors can influence the development of neutralizing antibodies to BoNTA. These factors include dose, intervals between treatment, and the formulation of the toxin.

Objective: To assess the rate of neutralizing antibody formation with intradermal injections of the current formulation of BoNTA in BoNTA-naive patients treated for primary axillary hyperhidrosis.

Methods: Antibody samples were obtained from 3 clinical studies in which patients were treated with BoNTA for primary axillary hyperhidrosis. Serum samples were obtained at baseline, prior to each repeat injection, and at study exit. Patients received between 1 to 4 intradermal treatments of BoNTA (doses 100 or 150U; total maximum exposure: 600U). The presence of neutralizing antibodies to BoNTA was assessed using the mouse protection assay.

Results: In total, 277 patients received one treatment with BoNTA, 182 patients received 2 treatments, 40 received 3 treatments, and 2 received 4 treatments (mean dose 111.12U per treatment). Of the 931 post-treatment samples that were of sufficient quantity to analyze, the mouse protection assay indicated no neutralizing antibodies for 916 (98.4%), presence of neutralizing antibodies for 1 (0.1%), and inconclusive for 14 (1.4%). The patient tested positive for toxin neutralizing antibodies had received one treatment session with BoNTA (100U), testing positive at the exit visit. This patient demonstrated a clinical response to treatment at the time of testing for neutralizing antibodies; subsequent testing post-study did not indicate the presence of neutralizing antibodies.

Conclusion: There was a 0.1% rate of toxin neutralizing antibody formation in patients who received repeat BoNTA intradermal injections for the treatment of primary axillary hyperhidrosis with the current BoNTA formulation used in these studies.