Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications
Identifieur interne : 000485 ( Istex/Corpus ); précédent : 000484; suivant : 000486Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications
Auteurs : Markus Naumann ; Alastair Carruthers ; Jean Carruthers ; Sheena K. Aurora ; Ross Zafonte ; Susan Abu-Shakra ; Terry Boodhoo ; Mary Ann Miller-Messana ; George Demos ; Lynn James ; Frederick Beddingfield ; Amanda Vandenburgh ; Mary Ann Chapman ; Mitchell F. BrinSource :
- Movement Disorders [ 0885-3185 ] ; 2010-10-15.
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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
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications</title><author><name sortKey="Naumann, Markus" sort="Naumann, Markus" uniqKey="Naumann M" first="Markus" last="Naumann">Markus Naumann</name><affiliation><mods:affiliation>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Carruthers, Alastair" sort="Carruthers, Alastair" uniqKey="Carruthers A" first="Alastair" last="Carruthers">Alastair Carruthers</name><affiliation><mods:affiliation>Department of Dermatology and Skin Science, University of British Columbia, Canada</mods:affiliation></affiliation></author><author><name sortKey="Carruthers, Jean" sort="Carruthers, Jean" uniqKey="Carruthers J" first="Jean" last="Carruthers">Jean Carruthers</name><affiliation><mods:affiliation>Department of Ophthalmology and Visual Sciences, University of British Columbia, Canada</mods:affiliation></affiliation></author><author><name sortKey="Aurora, Sheena K" sort="Aurora, Sheena K" uniqKey="Aurora S" first="Sheena K." last="Aurora">Sheena K. Aurora</name><affiliation><mods:affiliation>Swedish Pain and Headache Center, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="Zafonte, Ross" sort="Zafonte, Ross" uniqKey="Zafonte R" first="Ross" last="Zafonte">Ross Zafonte</name><affiliation><mods:affiliation>Harvard Medical School, Spaulding Rehabilitation Hospital Massachusetts General Hospital, Boston, Massachusetts, USA</mods:affiliation></affiliation></author><author><name sortKey="Abu Hakra, Susan" sort="Abu Hakra, Susan" uniqKey="Abu Hakra S" first="Susan" last="Abu-Shakra">Susan Abu-Shakra</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Current Address: Elan Pharmaceuticals, Inc., South San Francisco, CA</mods:affiliation></affiliation></author><author><name sortKey="Boodhoo, Terry" sort="Boodhoo, Terry" uniqKey="Boodhoo T" first="Terry" last="Boodhoo">Terry Boodhoo</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Miller Essana, Mary Ann" sort="Miller Essana, Mary Ann" uniqKey="Miller Essana M" first="Mary Ann" last="Miller-Messana">Mary Ann Miller-Messana</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Demos, George" sort="Demos, George" uniqKey="Demos G" first="George" last="Demos">George Demos</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="James, Lynn" sort="James, Lynn" uniqKey="James L" first="Lynn" last="James">Lynn James</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Beddingfield, Frederick" sort="Beddingfield, Frederick" uniqKey="Beddingfield F" first="Frederick" last="Beddingfield">Frederick Beddingfield</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, USA</mods:affiliation></affiliation></author><author><name sortKey="Vandenburgh, Amanda" sort="Vandenburgh, Amanda" uniqKey="Vandenburgh A" first="Amanda" last="Vandenburgh">Amanda Vandenburgh</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Chapman, Mary Ann" sort="Chapman, Mary Ann" uniqKey="Chapman M" first="Mary Ann" last="Chapman">Mary Ann Chapman</name><affiliation><mods:affiliation>Visage Communications, Mead, Washington, USA</mods:affiliation></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><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Neurology, University of California, Irvine, California, USA</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:9D49D0608959680754775765CD828182E3869E3E</idno><date when="2010" year="2010">2010</date><idno type="doi">10.1002/mds.23254</idno><idno type="url">https://api.istex.fr/document/9D49D0608959680754775765CD828182E3869E3E/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000485</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications</title><author><name sortKey="Naumann, Markus" sort="Naumann, Markus" uniqKey="Naumann M" first="Markus" last="Naumann">Markus Naumann</name><affiliation><mods:affiliation>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Carruthers, Alastair" sort="Carruthers, Alastair" uniqKey="Carruthers A" first="Alastair" last="Carruthers">Alastair Carruthers</name><affiliation><mods:affiliation>Department of Dermatology and Skin Science, University of British Columbia, Canada</mods:affiliation></affiliation></author><author><name sortKey="Carruthers, Jean" sort="Carruthers, Jean" uniqKey="Carruthers J" first="Jean" last="Carruthers">Jean Carruthers</name><affiliation><mods:affiliation>Department of Ophthalmology and Visual Sciences, University of British Columbia, Canada</mods:affiliation></affiliation></author><author><name sortKey="Aurora, Sheena K" sort="Aurora, Sheena K" uniqKey="Aurora S" first="Sheena K." last="Aurora">Sheena K. Aurora</name><affiliation><mods:affiliation>Swedish Pain and Headache Center, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="Zafonte, Ross" sort="Zafonte, Ross" uniqKey="Zafonte R" first="Ross" last="Zafonte">Ross Zafonte</name><affiliation><mods:affiliation>Harvard Medical School, Spaulding Rehabilitation Hospital Massachusetts General Hospital, Boston, Massachusetts, USA</mods:affiliation></affiliation></author><author><name sortKey="Abu Hakra, Susan" sort="Abu Hakra, Susan" uniqKey="Abu Hakra S" first="Susan" last="Abu-Shakra">Susan Abu-Shakra</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Current Address: Elan Pharmaceuticals, Inc., South San Francisco, CA</mods:affiliation></affiliation></author><author><name sortKey="Boodhoo, Terry" sort="Boodhoo, Terry" uniqKey="Boodhoo T" first="Terry" last="Boodhoo">Terry Boodhoo</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Miller Essana, Mary Ann" sort="Miller Essana, Mary Ann" uniqKey="Miller Essana M" first="Mary Ann" last="Miller-Messana">Mary Ann Miller-Messana</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Demos, George" sort="Demos, George" uniqKey="Demos G" first="George" last="Demos">George Demos</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="James, Lynn" sort="James, Lynn" uniqKey="James L" first="Lynn" last="James">Lynn James</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Beddingfield, Frederick" sort="Beddingfield, Frederick" uniqKey="Beddingfield F" first="Frederick" last="Beddingfield">Frederick Beddingfield</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, USA</mods:affiliation></affiliation></author><author><name sortKey="Vandenburgh, Amanda" sort="Vandenburgh, Amanda" uniqKey="Vandenburgh A" first="Amanda" last="Vandenburgh">Amanda Vandenburgh</name><affiliation><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Chapman, Mary Ann" sort="Chapman, Mary Ann" uniqKey="Chapman M" first="Mary Ann" last="Chapman">Mary Ann Chapman</name><affiliation><mods:affiliation>Visage Communications, Mead, Washington, USA</mods:affiliation></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><mods:affiliation>Allergan, Inc., Irvine, California, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Neurology, University of California, Irvine, California, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-10-15">2010-10-15</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">13</biblScope><biblScope unit="page" from="2211">2211</biblScope><biblScope unit="page" to="2218">2218</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">9D49D0608959680754775765CD828182E3869E3E</idno><idno type="DOI">10.1002/mds.23254</idno><idno type="ArticleID">MDS23254</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>antigenicity</term><term>botulinum toxin</term><term>cervical dystonia</term><term>facial aesthetics</term><term>hyperhidrosis</term><term>immunogenicity</term><term>neutralizing antibodies</term><term>overactive bladder</term><term>spasticity</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></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. © 2010 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Markus Naumann MD</name><affiliations><json:string>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg, Germany</json:string></affiliations></json:item><json:item><name>Alastair Carruthers MD</name><affiliations><json:string>Department of Dermatology and Skin Science, University of British Columbia, Canada</json:string></affiliations></json:item><json:item><name>Jean Carruthers MD</name><affiliations><json:string>Department of Ophthalmology and Visual Sciences, University of British Columbia, Canada</json:string></affiliations></json:item><json:item><name>Sheena K. Aurora MD</name><affiliations><json:string>Swedish Pain and Headache Center, Seattle, Washington, USA</json:string></affiliations></json:item><json:item><name>Ross Zafonte DO</name><affiliations><json:string>Harvard Medical School, Spaulding Rehabilitation Hospital Massachusetts General Hospital, Boston, Massachusetts, USA</json:string></affiliations></json:item><json:item><name>Susan Abu‐Shakra MD</name><affiliations><json:string>Allergan, Inc., Irvine, California, USA</json:string><json:string>Current Address: Elan Pharmaceuticals, Inc., South San Francisco, CA</json:string></affiliations></json:item><json:item><name>Terry Boodhoo MS</name><affiliations><json:string>Allergan, Inc., Irvine, California, USA</json:string></affiliations></json:item><json:item><name>Mary Ann Miller‐Messana RN</name><affiliations><json:string>Allergan, Inc., Irvine, California, USA</json:string></affiliations></json:item><json:item><name>George Demos MD</name><affiliations><json:string>Allergan, Inc., Irvine, California, USA</json:string></affiliations></json:item><json:item><name>Lynn James MPH</name><affiliations><json:string>Allergan, Inc., Irvine, California, USA</json:string></affiliations></json:item><json:item><name>Frederick Beddingfield MD, PhD</name><affiliations><json:string>Allergan, Inc., Irvine, California, USA</json:string><json:string>Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, USA</json:string></affiliations></json:item><json:item><name>Amanda VanDenburgh PhD</name><affiliations><json:string>Allergan, Inc., Irvine, California, USA</json:string></affiliations></json:item><json:item><name>Mary Ann Chapman PhD</name><affiliations><json:string>Visage Communications, Mead, Washington, USA</json:string></affiliations></json:item><json:item><name>Mitchell F. Brin MD</name><affiliations><json:string>Allergan, Inc., Irvine, California, USA</json:string><json:string>Department of Neurology, University of California, Irvine, California, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>botulinum toxin</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>cervical dystonia</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>hyperhidrosis</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>facial aesthetics</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>spasticity</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>overactive bladder</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>immunogenicity</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>antigenicity</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>neutralizing antibodies</value></json:item></subject><language><json:string>eng</json:string></language><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</abstract><qualityIndicators><score>7.536</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1573</abstractCharCount><pdfWordCount>4908</pdfWordCount><pdfCharCount>33187</pdfCharCount><pdfPageCount>8</pdfPageCount><abstractWordCount>219</abstractWordCount></qualityIndicators><title>Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications</title><genre><json:string>Serial article</json:string></genre><host><volume>25</volume><pages><total>8</total><last>2218</last><first>2211</first></pages><issn><json:string>0885-3185</json:string></issn><issue>13</issue><subject><json:item><value>Research Article</value></json:item></subject><genre></genre><language><json:string>unknown</json:string></language><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>2010</publicationDate><copyrightDate>2010</copyrightDate><doi><json:string>10.1002/mds.23254</json:string></doi><id>9D49D0608959680754775765CD828182E3869E3E</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/9D49D0608959680754775765CD828182E3869E3E/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/9D49D0608959680754775765CD828182E3869E3E/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/9D49D0608959680754775765CD828182E3869E3E/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>Wiley Subscription Services, Inc., A Wiley Company</p></availability><date>2010</date></publicationStmt><notesStmt><note type="content">*Potential conflict of interest: This analysis and the trials included herein were sponsored by Allergan, Inc., the manufacturer of BOTOX® (onabotulinumtoxinA). Please see the financial disclosures section for full author disclosures and potential conflicts of interest.</note><note>Allergan, Inc., Irvine, CA, USA</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications</title><author><persName><forename type="first">Markus</forename><surname>Naumann</surname><roleName type="degree">MD</roleName></persName><note type="correspondence"><p>Correspondence: Klinikum Augsburg Neurologische Klinik, Stenglinstr. 2, 86156 Augsburg, Bayern, Germany</p></note><affiliation>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg, Germany</affiliation></author><author><persName><forename type="first">Alastair</forename><surname>Carruthers</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Dermatology and Skin Science, University of British Columbia, Canada</affiliation></author><author><persName><forename type="first">Jean</forename><surname>Carruthers</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Ophthalmology and Visual Sciences, University of British Columbia, Canada</affiliation></author><author><persName><forename type="first">Sheena K.</forename><surname>Aurora</surname><roleName type="degree">MD</roleName></persName><affiliation>Swedish Pain and Headache Center, Seattle, Washington, USA</affiliation></author><author><persName><forename type="first">Ross</forename><surname>Zafonte</surname><roleName type="degree">DO</roleName></persName><affiliation>Harvard Medical School, Spaulding Rehabilitation Hospital Massachusetts General Hospital, Boston, Massachusetts, USA</affiliation></author><author><persName><forename type="first">Susan</forename><surname>Abu‐Shakra</surname><roleName type="degree">MD</roleName></persName><affiliation>Allergan, Inc., Irvine, California, USA</affiliation><affiliation>Current Address: Elan Pharmaceuticals, Inc., South San Francisco, CA</affiliation></author><author><persName><forename type="first">Terry</forename><surname>Boodhoo</surname><roleName type="degree">MS</roleName></persName><affiliation>Allergan, Inc., Irvine, California, USA</affiliation></author><author><persName><forename type="first">Mary Ann</forename><surname>Miller‐Messana</surname><roleName type="degree">RN</roleName></persName><affiliation>Allergan, Inc., Irvine, California, USA</affiliation></author><author><persName><forename type="first">George</forename><surname>Demos</surname><roleName type="degree">MD</roleName></persName><affiliation>Allergan, Inc., Irvine, California, USA</affiliation></author><author><persName><forename type="first">Lynn</forename><surname>James</surname><roleName type="degree">MPH</roleName></persName><affiliation>Allergan, Inc., Irvine, California, USA</affiliation></author><author><persName><forename type="first">Frederick</forename><surname>Beddingfield</surname><roleName type="degree">MD, PhD</roleName></persName><affiliation>Allergan, Inc., Irvine, California, USA</affiliation><affiliation>Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, USA</affiliation></author><author><persName><forename type="first">Amanda</forename><surname>VanDenburgh</surname><roleName type="degree">PhD</roleName></persName><affiliation>Allergan, Inc., Irvine, California, USA</affiliation></author><author><persName><forename type="first">Mary Ann</forename><surname>Chapman</surname><roleName type="degree">PhD</roleName></persName><affiliation>Visage Communications, Mead, Washington, USA</affiliation></author><author><persName><forename type="first">Mitchell F.</forename><surname>Brin</surname><roleName type="degree">MD</roleName></persName><affiliation>Allergan, Inc., Irvine, California, USA</affiliation><affiliation>Department of Neurology, University of California, Irvine, California, USA</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-10-15"></date><biblScope unit="vol">25</biblScope><biblScope unit="issue">13</biblScope><biblScope unit="page" from="2211">2211</biblScope><biblScope unit="page" to="2218">2218</biblScope></imprint></monogr><idno type="istex">9D49D0608959680754775765CD828182E3869E3E</idno><idno type="DOI">10.1002/mds.23254</idno><idno type="ArticleID">MDS23254</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2010</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>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</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>botulinum toxin</term></item><item><term>cervical dystonia</term></item><item><term>hyperhidrosis</term></item><item><term>facial aesthetics</term></item><item><term>spasticity</term></item><item><term>overactive bladder</term></item><item><term>immunogenicity</term></item><item><term>antigenicity</term></item><item><term>neutralizing antibodies</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>Article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2009-10-01">Received</change><change when="2010-04-20">Registration</change><change when="2010-10-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/9D49D0608959680754775765CD828182E3869E3E/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov. Disord.</title></titleGroup></publicationMeta><publicationMeta level="part" position="130"><doi origin="wiley" registered="yes">10.1002/mds.v25:13</doi><numberingGroup><numbering type="journalVolume" number="25">25</numbering><numbering type="journalIssue">13</numbering></numberingGroup><coverDate startDate="2010-10-15">15 October 2010</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="290" status="forIssue"><doi origin="wiley" registered="yes">10.1002/mds.23254</doi><idGroup><id type="unit" value="MDS23254"></id></idGroup><countGroup><count type="pageTotal" number="8"></count></countGroup><titleGroup><title type="articleCategory">Research Article</title><title type="tocHeading1">Research Articles</title></titleGroup><copyright ownership="thirdParty">Copyright © 2010 Movement Disorder Society</copyright><eventGroup><event type="manuscriptReceived" date="2009-10-01"></event><event type="manuscriptRevised" date="2010-04-14"></event><event 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href="file:MDS.MDS23254.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="0"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="34"></count><count type="wordTotal" number="6444"></count></countGroup><titleGroup><title type="main" xml:lang="en">Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications<link href="#fn3"></link></title><title type="short" xml:lang="en">nAbs with Onabotulinumtoxina</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Markus</givenNames><familyName>Naumann</familyName><degrees>MD</degrees></personName><contactDetails><email normalForm="markus.naumann@klinikum-augsburg.de">markus.naumann@klinikum‐augsburg.de</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Alastair</givenNames><familyName>Carruthers</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Jean</givenNames><familyName>Carruthers</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Sheena K.</givenNames><familyName>Aurora</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Ross</givenNames><familyName>Zafonte</familyName><degrees>DO</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6" currentRef="#curr1"><personName><givenNames>Susan</givenNames><familyName>Abu‐Shakra</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Terry</givenNames><familyName>Boodhoo</familyName><degrees>MS</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Mary Ann</givenNames><familyName>Miller‐Messana</familyName><degrees>RN</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af6"><personName><givenNames>George</givenNames><familyName>Demos</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au10" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Lynn</givenNames><familyName>James</familyName><degrees>MPH</degrees></personName></creator><creator xml:id="au11" creatorRole="author" affiliationRef="#af6 #af7"><personName><givenNames>Frederick</givenNames><familyName>Beddingfield</familyName><degrees>MD, PhD</degrees></personName></creator><creator xml:id="au12" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Amanda</givenNames><familyName>VanDenburgh</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au13" creatorRole="author" affiliationRef="#af8"><personName><givenNames>Mary Ann</givenNames><familyName>Chapman</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au14" creatorRole="author" affiliationRef="#af6 #af9"><personName><givenNames>Mitchell F.</givenNames><familyName>Brin</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="DE" type="organization"><unparsedAffiliation>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="CA" type="organization"><unparsedAffiliation>Department of Dermatology and Skin Science, University of British Columbia, Canada</unparsedAffiliation></affiliation><affiliation xml:id="af3" 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countryCode="US" type="organization"><unparsedAffiliation>Visage Communications, Mead, Washington, USA</unparsedAffiliation></affiliation><affiliation xml:id="af9" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of California, Irvine, California, USA</unparsedAffiliation></affiliation><affiliation xml:id="curr1"><unparsedAffiliation>Elan Pharmaceuticals, Inc., South San Francisco, CA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">botulinum toxin</keyword><keyword xml:id="kwd2">cervical dystonia</keyword><keyword xml:id="kwd3">hyperhidrosis</keyword><keyword xml:id="kwd4">facial aesthetics</keyword><keyword xml:id="kwd5">spasticity</keyword><keyword xml:id="kwd6">overactive bladder</keyword><keyword xml:id="kwd7">immunogenicity</keyword><keyword xml:id="kwd8">antigenicity</keyword><keyword xml:id="kwd9">neutralizing antibodies</keyword></keywordGroup><fundingInfo><fundingAgency>Allergan, Inc., Irvine, CA, USA</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>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</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn3"><p>Potential conflict of interest: This analysis and the trials included herein were sponsored by Allergan, Inc., the manufacturer of BOTOX® (onabotulinumtoxinA). 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Augsburg Neurologische Klinik, Stenglinstr. 2, 86156 Augsburg, Bayern, Germany</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Alastair</namePart><namePart type="family">Carruthers</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Dermatology and Skin Science, University of British Columbia, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jean</namePart><namePart type="family">Carruthers</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Ophthalmology and Visual Sciences, University of British Columbia, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sheena K.</namePart><namePart type="family">Aurora</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Swedish Pain and Headache Center, 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Irvine, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mary Ann</namePart><namePart type="family">Miller‐Messana</namePart><namePart type="termsOfAddress">RN</namePart><affiliation>Allergan, Inc., Irvine, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">George</namePart><namePart type="family">Demos</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Allergan, Inc., Irvine, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Lynn</namePart><namePart type="family">James</namePart><namePart type="termsOfAddress">MPH</namePart><affiliation>Allergan, Inc., Irvine, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Frederick</namePart><namePart 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unit="tables">3</extent><extent unit="references">34</extent><extent unit="words">6444</extent></physicalDescription><abstract 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</abstract><note type="content">*Potential conflict of interest: This analysis and the trials included herein were sponsored by Allergan, Inc., the manufacturer of BOTOX® (onabotulinumtoxinA). Please see the financial disclosures section for full author disclosures and potential conflicts of interest.</note><note type="funding">Allergan, Inc., Irvine, CA, USA</note><subject lang="en"><genre>Keywords</genre><topic>botulinum toxin</topic><topic>cervical dystonia</topic><topic>hyperhidrosis</topic><topic>facial aesthetics</topic><topic>spasticity</topic><topic>overactive bladder</topic><topic>immunogenicity</topic><topic>antigenicity</topic><topic>neutralizing antibodies</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. 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