Translational Neurosciences - Review article

Journal of Neural Transmission

, Volume 120, Issue 2, pp 275-290

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

Immunogenicity of botulinum toxins

  • Markus NaumannAffiliated withDepartment of Neurology, Klinikum Augsburg
  • , Lee Ming BooAffiliated withMedical Affairs, Allergan, Inc.
  • , Alan H. AckermanAffiliated withMedical Affairs, Allergan, Inc.
  • , Conor J. GallagherAffiliated withMedical Affairs, Allergan, Inc. Email author 


Botulinum neurotoxins are formulated biologic pharmaceuticals used therapeutically to treat a wide variety of chronic conditions, with varying governmental approvals by country. Some of these disorders include cervical dystonia, post-stroke spasticity, blepharospasm, migraine, and hyperhidrosis. Botulinum neurotoxins also have varying governmental approvals for cosmetic applications. As botulinum neurotoxin therapy is often continued over many years, some patients may develop detectable antibodies that may or may not affect their biological activity. Although botulinum neurotoxins are considered “lower risk” biologics since antibodies that may develop are not likely to cross react with endogenous proteins, it is possible that patients may lose their therapeutic response. Various factors impact the immunogenicity of botulinum neurotoxins, including product-related factors such as the manufacturing process, the antigenic protein load, and the presence of accessory proteins, as well as treatment-related factors such as the overall toxin dose, booster injections, and prior vaccination or exposure. Detection of antibodies by laboratory tests does not necessarily predict the clinical success or failure of treatment. Overall, botulinum neurotoxin type A products exhibit low clinically detectable levels of antibodies when compared with other approved biologic products. This review provides an overview of all current botulinum neurotoxin products available commercially, with respect to the development of neutralizing antibodies and clinical response.


Botulinum neurotoxins Neutralizing antibodies Cervical dystonia Torticollis Blepharospasm Hyperhidrosis