Immunogenicity of botulinum toxins
Open Access
- 25 September 2012
- journal article
- review article
- Published by Springer Science and Business Media LLC in Journal of Neural Transmission
- Vol. 120 (2), 275-290
- https://doi.org/10.1007/s00702-012-0893-9
Abstract
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.Keywords
This publication has 104 references indexed in Scilit:
- Botulinum Neurotoxin Is Shielded by NTNHA in an Interlocked ComplexScience, 2012
- Structural Basis of TLR5-Flagellin Recognition and SignalingScience, 2012
- Modulation of botulinum toxin-induced changes in neuromuscular function with antibodies directed against recombinant polypeptides or fragmentsNeuroscience, 2011
- Complexing proteins in botulinum toxin type A drugs: a help or a hindrance?Biologics: Targets and Therapy, 2010
- Comparing two types of botulinum‐A toxin detrusor injections in patients with severe neurogenic detrusor overactivity: a case‐control studyBJU International, 2009
- Prevalence of neutralising antibodies in patients treated with botulinum toxin type A for spasticityJournal of Neural Transmission, 2009
- Production of anti-neurotoxin antibody is enhanced by two subcomponents, HA1 and HA3b, of Clostridium botulinum type B 16S toxin–haemagglutininMicrobiology, 2005
- Long‐term follow‐up of cervical dystonia patients treated with botulinum toxin AMovement Disorders, 2003
- Comparison of mouse bioassay and immunoprecipitation assay for botulinum toxin antibodiesJournal of Neurology, Neurosurgery & Psychiatry, 1999
- The EDB Test—A clinical test for the detection of antibodies to botulinum toxin type AMovement Disorders, 1997