Movement Disorders (revue)

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Meta-Analysis of Neutralizing Antibody Conversion with OnabotulinumtoxinA (BOTOX®) Across Multiple Indications

Identifieur interne : 002555 ( Main/Merge ); précédent : 002554; suivant : 002556

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 : Pascal:10-0474351

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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.

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Pascal:10-0474351

Le document en format XML

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<title xml:lang="en" level="a">Meta-Analysis of Neutralizing Antibody Conversion with OnabotulinumtoxinA (BOTOX®) Across Multiple Indications</title>
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<country>États-Unis</country>
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<region type="state">Washington (État)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F." last="Brin">Mitchell F. Brin</name>
<affiliation wicri:level="2">
<inist:fA14 i1="06">
<s1>Allergan, Inc.</s1>
<s2>Irvine, California</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
<affiliation wicri:level="2">
<inist:fA14 i1="09">
<s1>Department of Neurology, University of California</s1>
<s2>Irvine, California</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
<imprint>
<date when="2010">2010</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Aesthetics</term>
<term>Bontoxilysin</term>
<term>Drug conversion</term>
<term>Dystonia</term>
<term>Hyperhidrosis</term>
<term>Immunogenicity</term>
<term>Indication</term>
<term>Nervous system diseases</term>
<term>Overactive bladder</term>
<term>Spasticity</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Dystonie</term>
<term>Hyperhidrose</term>
<term>Hypertonie spastique</term>
<term>Vessie hyperactive</term>
<term>Pathologie du système nerveux</term>
<term>Changement médicament</term>
<term>Indication</term>
<term>Bontoxilysin</term>
<term>Esthétique</term>
<term>Immunogénicité</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<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.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Canada</li>
<li>États-Unis</li>
</country>
<region>
<li>Bavière</li>
<li>Californie</li>
<li>District de Souabe</li>
<li>Massachusetts</li>
<li>Washington (État)</li>
</region>
<settlement>
<li>Augsbourg</li>
<li>Los Angeles</li>
</settlement>
</list>
<tree>
<country name="Allemagne">
<region name="Bavière">
<name sortKey="Naumann, Markus" sort="Naumann, Markus" uniqKey="Naumann M" first="Markus" last="Naumann">Markus Naumann</name>
</region>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Carruthers, Alastair" sort="Carruthers, Alastair" uniqKey="Carruthers A" first="Alastair" last="Carruthers">Alastair Carruthers</name>
</noRegion>
<name sortKey="Carruthers, Jean" sort="Carruthers, Jean" uniqKey="Carruthers J" first="Jean" last="Carruthers">Jean Carruthers</name>
</country>
<country name="États-Unis">
<region name="Washington (État)">
<name sortKey="Aurora, Sheena K" sort="Aurora, Sheena K" uniqKey="Aurora S" first="Sheena K." last="Aurora">Sheena K. Aurora</name>
</region>
<name sortKey="Abu Shakra, Susan" sort="Abu Shakra, Susan" uniqKey="Abu Shakra S" first="Susan" last="Abu-Shakra">Susan Abu-Shakra</name>
<name sortKey="Beddingfield, Frederick" sort="Beddingfield, Frederick" uniqKey="Beddingfield F" first="Frederick" last="Beddingfield">Frederick Beddingfield</name>
<name sortKey="Beddingfield, Frederick" sort="Beddingfield, Frederick" uniqKey="Beddingfield F" first="Frederick" last="Beddingfield">Frederick Beddingfield</name>
<name sortKey="Boodhoo, Terry" sort="Boodhoo, Terry" uniqKey="Boodhoo T" first="Terry" last="Boodhoo">Terry Boodhoo</name>
<name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F." last="Brin">Mitchell F. Brin</name>
<name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F." last="Brin">Mitchell F. Brin</name>
<name sortKey="Chapman, Mary Ann" sort="Chapman, Mary Ann" uniqKey="Chapman M" first="Mary Ann" last="Chapman">Mary Ann Chapman</name>
<name sortKey="Demos, George" sort="Demos, George" uniqKey="Demos G" first="George" last="Demos">George Demos</name>
<name sortKey="James, Lynn" sort="James, Lynn" uniqKey="James L" first="Lynn" last="James">Lynn James</name>
<name sortKey="Miller Messana, Mary Ann" sort="Miller Messana, Mary Ann" uniqKey="Miller Messana M" first="Mary Ann" last="Miller-Messana">Mary Ann Miller-Messana</name>
<name sortKey="Vandenburgh, Amanda" sort="Vandenburgh, Amanda" uniqKey="Vandenburgh A" first="Amanda" last="Vandenburgh">Amanda Vandenburgh</name>
<name sortKey="Zafonte, Ross" sort="Zafonte, Ross" uniqKey="Zafonte R" first="Ross" last="Zafonte">Ross Zafonte</name>
</country>
</tree>
</affiliations>
</record>

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