Category: Neuropharmacology
Objective: A meta-analysis of clinical trial data across 10 indications for onabotulinumtoxinA was performed to assess incidence of neutralizing antibody (nAb) formation with a focus on movement disorders, including cervical dystonia (CD), post-stroke spasticity, and pediatric lower limb spasticity.
Background: Formation of nAb may reduce the effectiveness of onabotulinumtoxinA treatment. An extensive clinical trial database in different patient populations has been accumulated for onabotulinumtoxinA over the past 3 decades.
Method: This analysis was based on nearly 30,000 patient records from placebo-controlled or prospective, open-label trials across therapeutic and aesthetic indications with immunogenicity assessment in 6146 patients treated for up to 15 cycles. Total onabotulinumtoxinA doses per treatment ranged between 10 U (glabellar lines) and 600 U (post-stroke spasticity). Detection of nAb at baseline and post-treatment was by mouse protection assay, either as a single step or following positive binding Ab assay results.
Results: Frequency of subjects who had positive nAb results (with either a nAb-negative or unknown status at baseline) at any post-treatment time point ranged from 0% (crow’s feet lines, migraine, and pediatric neurogenic overactive bladder) to 1.4% (neurogenic overactive bladder). Overall, across all 10 indications, 27/5876 subjects (0.5%) had positive nAb results. Nine of these 27 subjects were treated for movement disorders (CD, n=4 of 319 subjects (1.3%); post-stroke spasticity, n=2 of 406 subjects (0.5%); and pediatric lower-limb spasticity, n=3 of 299 subjects (1.0%)). Due to the low incidence and lack of consistent pattern, no clear correlation was observed between positive nAb results and onabotulinumtoxinA dose level or number of treatment cycles.
Conclusion: This comprehensive, robust meta-analysis confirms the low frequency of nAb formation following onabotulinumtoxinA treatments across multiple indications, including CD and spasticity.
To cite this abstract in AMA style:
J. Jankovic, J. Carruthers, M. Naumann, T. Boodhoo, S. Gupta, M. Attar, R. Singh, I. Yushmanova, J. Soliman, MF. Brin, J. Shen. Neutralizing Antibody Conversion With OnabotulinumtoxinA From Global Studies Across Multiple Indications With A Focus On Movement Disorders: A Meta-Analysis [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/neutralizing-antibody-conversion-with-onabotulinumtoxina-from-global-studies-across-multiple-indications-with-a-focus-on-movement-disorders-a-meta-analysis/. Accessed June 15, 2025.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/neutralizing-antibody-conversion-with-onabotulinumtoxina-from-global-studies-across-multiple-indications-with-a-focus-on-movement-disorders-a-meta-analysis/