Abstract Details

Title Neutralizing Antibody Conversion With Onabotulinumtoxina From Global Studies Across Multiple Indications In Nearly 30,000 Patient Records: A Meta-Analysis

Topic General Neurology

Presentation(s) S8 - General Neurology: Clinical Treatment and Practice (5:18 PM-5:30 PM)

Poster/Presentation
Number 010

Background NAbs may reduce the effectiveness of onabotulinumtoxinA treatment. An extensive clinical trial database across 10 indications in different patient populations has been accumulated for onabotulinumtoxinA over the past 3 decades.

Objective A meta-analysis of these data was performed to assess the incidence of neutralizing antibody (NAb) formation as a function of subject gender, indication (dose route and location), dose level, dosing interval, and number of treatment cycles.

Design/Methods This analysis was based on placebo-controlled or prospective, open-label trials across 10 therapeutic and aesthetic indications with immunogenicity assessment in 6118 patients treated 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 result 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, 27/5846 subjects (0.5%) fell into this category. By the time of final assessment at study exit, only 17/5846 subjects (0.3%) out of the 27 subjects still had positive NAb results. Due to the low incidence and lack of consistent pattern, no clear correlation was observed between positive NAb results and onabotulinumtoxinA dose level, dosing interval, subject gender, indication (dose route and location), or number of treatment cycles.

Conclusions This comprehensive and robust meta-analysis confirms the low frequency of NAb formation following onabotulinumtoxinA treatments across multiple indications.

Authors/Disclosures
Mitchell F. Brin, MD, FAAN (Abbvie / UC Irvine) PRESENTER	Dr. Brin has received personal compensation for serving as an employee of Allergan. Dr. Brin has stock in Allergan.
Joseph Jankovic, MD, FAAN (Baylor College of Medicine)	Dr. Jankovic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Jankovic has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance, Allergan. The institution of Dr. Jankovic has received research support from Baylor College of Medicine. Dr. Jankovic has received research support from Abbvie. The institution of Dr. Jankovic has received research support from Abbvie.
	No disclosure on file
Markus Naumann, MD (Klinikum Augsburg)	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Rita Singh, PharmD (Allergan)	Dr. Singh has received personal compensation for serving as an employee of AbbVie. Dr. Singh has stock in AbbVie.
	No disclosure on file
	No disclosure on file
	No disclosure on file