Movement Disorders (revue)

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Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications

Identifieur interne : 001B85 ( Main/Exploration ); précédent : 001B84; suivant : 001B86

Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications

Auteurs : Markus Naumann [Allemagne] ; Alastair Carruthers [Canada] ; Jean Carruthers [Canada] ; Sheena K. Aurora [États-Unis] ; Ross Zafonte [États-Unis] ; Susan Abu-Shakra [États-Unis] ; Terry Boodhoo [États-Unis] ; Mary Ann Miller-Messana [États-Unis] ; George Demos [États-Unis] ; Lynn James [États-Unis] ; Frederick Beddingfield [États-Unis] ; Amanda Vandenburgh [États-Unis] ; Mary Ann Chapman [États-Unis] ; Mitchell F. Brin [États-Unis]

Source :

RBID : ISTEX:9D49D0608959680754775765CD828182E3869E3E

Descripteurs français

English descriptors

Abstract

This meta‐analysis evaluated the frequency of neutralizing antibody (nAb) conversion with onabotulinumtoxinA (BOTOX®; Allergan) across five studied indications. The analysis was based on large, controlled or prospective, open‐label trials (durations 4 months to ≥2 years). Serum samples were analyzed for nAbs using the Mouse Protection Assay. Subjects who were antibody negative at baseline and had at least one analyzable postbaseline antibody assay result were included. The 16 clinical studies included 3,006 subjects; of these, 2,240 met the inclusion criteria for this analysis. Subjects received 1–15 treatments (mean 3.8 treatments) with onabotulinumtoxinA. Total doses per treatment cycle ranged from 10 or 20 units in glabellar lines to 20–500 units in cervical dystonia. The numbers of subjects who converted from an antibody‐negative status at baseline to antibody‐positive status at any post‐treatment time point were: cervical dystonia 4/312 (1.28%), glabellar lines 2/718 (0.28%), overactive bladder 0/22 (0%), post‐stroke spasticity 1/317 (0.32%), and primary axillary hyperhidrosis 4/871 (0.46%). Across all indications, 11/2,240 subjects (0.49%) converted from antibody negative at baseline to positive at one or more post‐treatment time points, but only three subjects became clinically unresponsive to onabotulinumtoxinA at some point following a positive assay. Based on these large trials, the frequency of antibody conversion after onabotulinumtoxinA treatment is very low, and infrequently leads to loss of efficacy. © 2010 Movement Disorder Society

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DOI: 10.1002/mds.23254


Affiliations:


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Le document en format XML

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<term>Adult</term>
<term>Aesthetics</term>
<term>Antibodies, Neutralizing (blood)</term>
<term>Bontoxilysin</term>
<term>Botulinum Toxins, Type A (immunology)</term>
<term>Botulinum Toxins, Type A (therapeutic use)</term>
<term>Drug conversion</term>
<term>Dystonia</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Hyperhidrosis</term>
<term>Immunogenicity</term>
<term>Indication</term>
<term>Middle Aged</term>
<term>Movement Disorders (blood)</term>
<term>Movement Disorders (drug therapy)</term>
<term>Movement Disorders (immunology)</term>
<term>Nervous system diseases</term>
<term>Overactive bladder</term>
<term>Prospective Studies</term>
<term>Spasticity</term>
<term>antigenicity</term>
<term>botulinum toxin</term>
<term>cervical dystonia</term>
<term>facial aesthetics</term>
<term>hyperhidrosis</term>
<term>immunogenicity</term>
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<term>Hyperhidrose</term>
<term>Hypertonie spastique</term>
<term>Immunogénicité</term>
<term>Indication</term>
<term>Pathologie du système nerveux</term>
<term>Vessie hyperactive</term>
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<div type="abstract" xml:lang="en">This meta‐analysis evaluated the frequency of neutralizing antibody (nAb) conversion with onabotulinumtoxinA (BOTOX®; Allergan) across five studied indications. The analysis was based on large, controlled or prospective, open‐label trials (durations 4 months to ≥2 years). Serum samples were analyzed for nAbs using the Mouse Protection Assay. Subjects who were antibody negative at baseline and had at least one analyzable postbaseline antibody assay result were included. The 16 clinical studies included 3,006 subjects; of these, 2,240 met the inclusion criteria for this analysis. Subjects received 1–15 treatments (mean 3.8 treatments) with onabotulinumtoxinA. Total doses per treatment cycle ranged from 10 or 20 units in glabellar lines to 20–500 units in cervical dystonia. The numbers of subjects who converted from an antibody‐negative status at baseline to antibody‐positive status at any post‐treatment time point were: cervical dystonia 4/312 (1.28%), glabellar lines 2/718 (0.28%), overactive bladder 0/22 (0%), post‐stroke spasticity 1/317 (0.32%), and primary axillary hyperhidrosis 4/871 (0.46%). Across all indications, 11/2,240 subjects (0.49%) converted from antibody negative at baseline to positive at one or more post‐treatment time points, but only three subjects became clinically unresponsive to onabotulinumtoxinA at some point following a positive assay. Based on these large trials, the frequency of antibody conversion after onabotulinumtoxinA treatment is very low, and infrequently leads to loss of efficacy. © 2010 Movement Disorder Society</div>
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