Purpose: Conflicting data have been reported regarding development of
serum antibodies to botulinum A toxin. The purpose of this study is to
determine conclusively whether antibody production to this toxin occu
rs in humans, and, if so, to determine its relationship, if any, to le
ngth of treatment, total cumulative dose, and clinical response to tre
atment. Methods: Sixty-five sera samples from 42 adults treated with b
otulinum A toxin for essential blepharospasm, hemifacial spasm, or spa
smodic torticollis were analyzed via a sphere-linked immunodiagnostic
assay for antibody production. Results were plotted against length of
treatment, number of injections, cumulative dose, and treatment effect
produced. Results: Twenty-four (57%) of the 42 patients produced anti
bodies in all three diagnostic groups. No significant differences were
found between antibody producers and nonproducers with respect to age
(P = 0.216), length of treatment (P = 0.586), number of injections (P
= 0.619), or total cumulative dose (P = 0.286). Within the antibody-p
roducing group, there was no significant correlation between amount of
antibody and length of treatment (P = 0.081), number of injections (P
= 0.1 34), or cumulative dose (P = 0.250). The presence of demonstrab
le antibodies in serum did not affect the clinical responsiveness to i
njection. Conclusion: Antibody production is present in a majority of
patients treated with botulinum A toxin. The sphere-linked immunodiagn
ostic assay is a reliable and reproducible method for detecting and qu
antifying these antibodies. When antibody production occurs, it is lik
ely due to variations in individual immune responsiveness and appears
to have no direct effect on the patient's clinical response to treatme
nt.