Meta-analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications.
Identifieur interne : 001609 ( PubMed/Corpus ); précédent : 001608; suivant : 001610Meta-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 : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2010.
English descriptors
- KwdEn :
- MESH :
- chemical , blood : Antibodies, Neutralizing.
- chemical , immunology : Botulinum Toxins, Type A.
- chemical , therapeutic use : Botulinum Toxins, Type A.
- blood : Movement Disorders.
- drug therapy : Movement Disorders.
- immunology : Movement Disorders.
- Adult, Follow-Up Studies, Humans, Middle Aged, Prospective Studies.
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.
DOI: 10.1002/mds.23254
PubMed: 20737546
Links to Exploration step
pubmed:20737546Le document en format XML
<record><TEI><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><nlm:affiliation>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg, Germany. markus.naumann@klinikum-augsburg.de</nlm:affiliation></affiliation></author><author><name sortKey="Carruthers, Alastair" sort="Carruthers, Alastair" uniqKey="Carruthers A" first="Alastair" last="Carruthers">Alastair Carruthers</name></author><author><name sortKey="Carruthers, Jean" sort="Carruthers, Jean" uniqKey="Carruthers J" first="Jean" last="Carruthers">Jean Carruthers</name></author><author><name sortKey="Aurora, Sheena K" sort="Aurora, Sheena K" uniqKey="Aurora S" first="Sheena K" last="Aurora">Sheena K. Aurora</name></author><author><name sortKey="Zafonte, Ross" sort="Zafonte, Ross" uniqKey="Zafonte R" first="Ross" last="Zafonte">Ross Zafonte</name></author><author><name sortKey="Abu Shakra, Susan" sort="Abu Shakra, Susan" uniqKey="Abu Shakra S" first="Susan" last="Abu-Shakra">Susan Abu-Shakra</name></author><author><name sortKey="Boodhoo, Terry" sort="Boodhoo, Terry" uniqKey="Boodhoo T" first="Terry" last="Boodhoo">Terry Boodhoo</name></author><author><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></author><author><name sortKey="Demos, George" sort="Demos, George" uniqKey="Demos G" first="George" last="Demos">George Demos</name></author><author><name sortKey="James, Lynn" sort="James, Lynn" uniqKey="James L" first="Lynn" last="James">Lynn James</name></author><author><name sortKey="Beddingfield, Frederick" sort="Beddingfield, Frederick" uniqKey="Beddingfield F" first="Frederick" last="Beddingfield">Frederick Beddingfield</name></author><author><name sortKey="Vandenburgh, Amanda" sort="Vandenburgh, Amanda" uniqKey="Vandenburgh A" first="Amanda" last="Vandenburgh">Amanda Vandenburgh</name></author><author><name sortKey="Chapman, Mary Ann" sort="Chapman, Mary Ann" uniqKey="Chapman M" first="Mary Ann" last="Chapman">Mary Ann Chapman</name></author><author><name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F" last="Brin">Mitchell F. Brin</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2010">2010</date><idno type="doi">10.1002/mds.23254</idno><idno type="RBID">pubmed:20737546</idno><idno type="pmid">20737546</idno><idno type="wicri:Area/PubMed/Corpus">001609</idno></publicationStmt><sourceDesc><biblStruct><analytic><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><nlm:affiliation>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg, Germany. markus.naumann@klinikum-augsburg.de</nlm:affiliation></affiliation></author><author><name sortKey="Carruthers, Alastair" sort="Carruthers, Alastair" uniqKey="Carruthers A" first="Alastair" last="Carruthers">Alastair Carruthers</name></author><author><name sortKey="Carruthers, Jean" sort="Carruthers, Jean" uniqKey="Carruthers J" first="Jean" last="Carruthers">Jean Carruthers</name></author><author><name sortKey="Aurora, Sheena K" sort="Aurora, Sheena K" uniqKey="Aurora S" first="Sheena K" last="Aurora">Sheena K. Aurora</name></author><author><name sortKey="Zafonte, Ross" sort="Zafonte, Ross" uniqKey="Zafonte R" first="Ross" last="Zafonte">Ross Zafonte</name></author><author><name sortKey="Abu Shakra, Susan" sort="Abu Shakra, Susan" uniqKey="Abu Shakra S" first="Susan" last="Abu-Shakra">Susan Abu-Shakra</name></author><author><name sortKey="Boodhoo, Terry" sort="Boodhoo, Terry" uniqKey="Boodhoo T" first="Terry" last="Boodhoo">Terry Boodhoo</name></author><author><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></author><author><name sortKey="Demos, George" sort="Demos, George" uniqKey="Demos G" first="George" last="Demos">George Demos</name></author><author><name sortKey="James, Lynn" sort="James, Lynn" uniqKey="James L" first="Lynn" last="James">Lynn James</name></author><author><name sortKey="Beddingfield, Frederick" sort="Beddingfield, Frederick" uniqKey="Beddingfield F" first="Frederick" last="Beddingfield">Frederick Beddingfield</name></author><author><name sortKey="Vandenburgh, Amanda" sort="Vandenburgh, Amanda" uniqKey="Vandenburgh A" first="Amanda" last="Vandenburgh">Amanda Vandenburgh</name></author><author><name sortKey="Chapman, Mary Ann" sort="Chapman, Mary Ann" uniqKey="Chapman M" first="Mary Ann" last="Chapman">Mary Ann Chapman</name></author><author><name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F" last="Brin">Mitchell F. Brin</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2010" type="published">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Antibodies, Neutralizing (blood)</term><term>Botulinum Toxins, Type A (immunology)</term><term>Botulinum Toxins, Type A (therapeutic use)</term><term>Follow-Up Studies</term><term>Humans</term><term>Middle Aged</term><term>Movement Disorders (blood)</term><term>Movement Disorders (drug therapy)</term><term>Movement Disorders (immunology)</term><term>Prospective Studies</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Neutralizing</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Botulinum Toxins, Type A</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Botulinum Toxins, Type A</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Movement Disorders</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Movement Disorders</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Movement Disorders</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Follow-Up Studies</term><term>Humans</term><term>Middle Aged</term><term>Prospective Studies</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. © 2010 Movement Disorder Society.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">20737546</PMID><DateCreated><Year>2010</Year><Month>10</Month><Day>08</Day></DateCreated><DateCompleted><Year>2011</Year><Month>01</Month><Day>26</Day></DateCompleted><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>25</Volume><Issue>13</Issue><PubDate><Year>2010</Year><Month>Oct</Month><Day>15</Day></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Meta-analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications.</ArticleTitle><Pagination><MedlinePgn>2211-8</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.23254</ELocationID><Abstract><AbstractText>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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Naumann</LastName><ForeName>Markus</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg, Germany. markus.naumann@klinikum-augsburg.de</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carruthers</LastName><ForeName>Alastair</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Carruthers</LastName><ForeName>Jean</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Aurora</LastName><ForeName>Sheena K</ForeName><Initials>SK</Initials></Author><Author ValidYN="Y"><LastName>Zafonte</LastName><ForeName>Ross</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Abu-Shakra</LastName><ForeName>Susan</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Boodhoo</LastName><ForeName>Terry</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Miller-Messana</LastName><ForeName>Mary Ann</ForeName><Initials>MA</Initials></Author><Author ValidYN="Y"><LastName>Demos</LastName><ForeName>George</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>James</LastName><ForeName>Lynn</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Beddingfield</LastName><ForeName>Frederick</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>VanDenburgh</LastName><ForeName>Amanda</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Chapman</LastName><ForeName>Mary Ann</ForeName><Initials>MA</Initials></Author><Author ValidYN="Y"><LastName>Brin</LastName><ForeName>Mitchell F</ForeName><Initials>MF</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D017418">Meta-Analysis</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D057134">Antibodies, Neutralizing</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C542870">onabotulinumtoxinA</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.24.69</RegistryNumber><NameOfSubstance UI="D019274">Botulinum Toxins, Type A</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D057134">Antibodies, Neutralizing</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000097">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019274">Botulinum Toxins, Type A</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000276">immunology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005500">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D009069">Movement Disorders</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000097">blood</QualifierName><QualifierName MajorTopicYN="N" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="N" UI="Q000276">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011446">Prospective Studies</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2010</Year><Month>8</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2010</Year><Month>8</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2011</Year><Month>1</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.23254</ArticleId><ArticleId IdType="pubmed">20737546</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/PubMed/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001609 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/PubMed/Corpus/biblio.hfd -nk 001609 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= MovDisordV3
|flux= PubMed
|étape= Corpus
|type= RBID
|clé= pubmed:20737546
|texte= Meta-analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/PubMed/Corpus/RBID.i -Sk "pubmed:20737546" \
| HfdSelect -Kh $EXPLOR_AREA/Data/PubMed/Corpus/biblio.hfd \
| NlmPubMed2Wicri -a MovDisordV3
| This area was generated with Dilib version V0.6.23. |  |