Meta‐analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications
Identifieur interne : 002021 ( Main/Merge ); précédent : 002020; suivant : 002022Meta‐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 :
- Movement Disorders [ 0885-3185 ] ; 2010-10-15.
English descriptors
- KwdEn :
- Adult, Antibodies, Neutralizing (blood), Botulinum Toxins, Type A (immunology), Botulinum Toxins, Type A (therapeutic use), Follow-Up Studies, Humans, Middle Aged, Movement Disorders (blood), Movement Disorders (drug therapy), Movement Disorders (immunology), Prospective Studies, antigenicity, botulinum toxin, cervical dystonia, facial aesthetics, hyperhidrosis, immunogenicity, neutralizing antibodies, overactive bladder, spasticity.
- 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
Url:
DOI: 10.1002/mds.23254
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<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>
<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>
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<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>
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<author><name sortKey="Abu Hakra, Susan" sort="Abu Hakra, Susan" uniqKey="Abu Hakra S" first="Susan" last="Abu-Shakra">Susan Abu-Shakra</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Allergan, Inc., Irvine, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>Current Address: Elan Pharmaceuticals, Inc., South San Francisco</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Boodhoo, Terry" sort="Boodhoo, Terry" uniqKey="Boodhoo T" first="Terry" last="Boodhoo">Terry Boodhoo</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Allergan, Inc., Irvine, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Allergan, Inc., Irvine, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Demos, George" sort="Demos, George" uniqKey="Demos G" first="George" last="Demos">George Demos</name>
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<wicri:regionArea>Allergan, Inc., Irvine, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="James, Lynn" sort="James, Lynn" uniqKey="James L" first="Lynn" last="James">Lynn James</name>
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<wicri:regionArea>Allergan, Inc., Irvine, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Beddingfield, Frederick" sort="Beddingfield, Frederick" uniqKey="Beddingfield F" first="Frederick" last="Beddingfield">Frederick Beddingfield</name>
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<wicri:regionArea>Allergan, Inc., Irvine, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
<affiliation wicri:level="3"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles</wicri:regionArea>
<placeName><settlement type="city">Los Angeles</settlement>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Vandenburgh, Amanda" sort="Vandenburgh, Amanda" uniqKey="Vandenburgh A" first="Amanda" last="Vandenburgh">Amanda Vandenburgh</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Allergan, Inc., Irvine, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Visage Communications, Mead, Washington</wicri:regionArea>
<placeName><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"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Allergan, Inc., Irvine, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, University of California, Irvine, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
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<monogr></monogr>
<series><title level="j">Movement Disorders</title>
<title level="j" type="abbrev">Mov. Disord.</title>
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<idno type="eISSN">1531-8257</idno>
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<date type="published" when="2010-10-15">2010-10-15</date>
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<idno type="istex">9D49D0608959680754775765CD828182E3869E3E</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>antigenicity</term>
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<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>
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<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>
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<PubMed><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 wicri:level="3"><nlm:affiliation>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg, Germany. markus.naumann@klinikum-augsburg.de</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg</wicri:regionArea>
<placeName><region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Souabe</region>
<settlement type="city">Augsbourg</settlement>
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</author>
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<author><name sortKey="Carruthers, Jean" sort="Carruthers, Jean" uniqKey="Carruthers J" first="Jean" last="Carruthers">Jean Carruthers</name>
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<author><name sortKey="Aurora, Sheena K" sort="Aurora, Sheena K" uniqKey="Aurora S" first="Sheena K" last="Aurora">Sheena K. Aurora</name>
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<author><name sortKey="Zafonte, Ross" sort="Zafonte, Ross" uniqKey="Zafonte R" first="Ross" last="Zafonte">Ross Zafonte</name>
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<author><name sortKey="Abu Shakra, Susan" sort="Abu Shakra, Susan" uniqKey="Abu Shakra S" first="Susan" last="Abu-Shakra">Susan Abu-Shakra</name>
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<author><name sortKey="Demos, George" sort="Demos, George" uniqKey="Demos G" first="George" last="Demos">George Demos</name>
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<author><name sortKey="Vandenburgh, Amanda" sort="Vandenburgh, Amanda" uniqKey="Vandenburgh A" first="Amanda" last="Vandenburgh">Amanda Vandenburgh</name>
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<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>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Meta-analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications.</title>
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<wicri:regionArea>Department of Neurology, Klinikum Augsburg Neurologische Klinik, Augsburg</wicri:regionArea>
<placeName><region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Souabe</region>
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</placeName>
</affiliation>
</author>
<author><name sortKey="Carruthers, Alastair" sort="Carruthers, Alastair" uniqKey="Carruthers A" first="Alastair" last="Carruthers">Alastair Carruthers</name>
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<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>
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<series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title>
<idno type="eISSN">1531-8257</idno>
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<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>
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<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Botulinum Toxins, Type A</term>
</keywords>
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</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>
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<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>
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</PubMed>
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