Long-Term Treatment with Botulinum Toxin Type A in Cervical Dystonia Has Low Immunogenicity by Mouse Protection Assay
Identifieur interne : 003812 ( Main/Merge ); précédent : 003811; suivant : 003813Long-Term Treatment with Botulinum Toxin Type A in Cervical Dystonia Has Low Immunogenicity by Mouse Protection Assay
Auteurs : Mitchell F. Brin [États-Unis] ; Cynthia L. Comella [États-Unis] ; Joseph Jankovic [États-Unis] ; Francis Lai [États-Unis] ; Markus Naumann [Allemagne]Source :
- Movement disorders [ 0885-3185 ] ; 2008.
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- Pascal (Inist)
English descriptors
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Abstract
To evaluate the immunogenicity of botulinum toxin type A (BoNTA; BOTOX) in cervical dystonia (CD). Subjects diagnosed with CD for ≥1 year and previously naive to BoNTs were treated with BoNTA in a prospective, open-label, multi-center study. Serum samples were analyzed for BoNTA neutralizing antibodies using the Mouse Protection Assay (MPA). Clinical resistance was assessed with a test injection of 20 U BoNTA placed unilaterally into the frontalis (Frontalis Antibody Test; FTAT) or corrugator muscle (Unilateral Brow Injection; UBI). Efficacy was assessed and adverse events were recorded. Of 326 subjects enrolled, 251 (77%) completed the study. Subjects received a median of 9 BoNTA treatments (mean dose per session ranged from 148.4 to 213.0 U over a mean of 2.5 years [range: 3.2 months-4.2 years]). Only 4 of 326 subjects (1.2%) tested positive for antibodies in the MPA; three of these subjects stopped responding clinically to BoNTA (of whom one also showed clinical resistance in the FTAT) and one continued to respond. Consistent improvements in the signs/symptoms of CD were noted. The most frequent treatment-related adverse events were mild to moderate weakness, dysphagia, neck pain, and injection-site pain. The current formulation of BoNTA rarely causes neutralizing antibody formation in CD subjects treated ≤4 years.
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Brin</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Allergan, Inc., Global Drug Development</s1><s2>Irvine, California</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>University of California</s1><s2>Irvine, California</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Rush University Medical Center</s1><s2>Chicago, Illinois</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Parkinson's Disease Center and Movement Disorders Clinic at Baylor College of Medicine</s1><s2>Houston, Texas</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Lai, Francis" sort="Lai, Francis" uniqKey="Lai F" first="Francis" last="Lai">Francis Lai</name><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Biostatistics, Allergan, Inc</s1><s2>Irvine, California</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Naumann, Markus" sort="Naumann, Markus" uniqKey="Naumann M" first="Markus" last="Naumann">Markus Naumann</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Klinikum Augsburg</s1><s2>Augsburg</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Souabe</region><settlement type="city">Augsbourg</settlement></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="2008">2008</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>Animal</term><term>Bontoxilysin</term><term>Dystonia</term><term>Immunogenicity</term><term>Long term</term><term>Mouse</term><term>Nervous system diseases</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Dystonie</term><term>Pathologie du système nerveux</term><term>Long terme</term><term>Traitement</term><term>Bontoxilysin</term><term>Immunogénicité</term><term>Animal</term><term>Souris</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">To evaluate the immunogenicity of botulinum toxin type A (BoNTA; BOTOX) in cervical dystonia (CD). Subjects diagnosed with CD for ≥1 year and previously naive to BoNTs were treated with BoNTA in a prospective, open-label, multi-center study. Serum samples were analyzed for BoNTA neutralizing antibodies using the Mouse Protection Assay (MPA). Clinical resistance was assessed with a test injection of 20 U BoNTA placed unilaterally into the frontalis (Frontalis Antibody Test; FTAT) or corrugator muscle (Unilateral Brow Injection; UBI). Efficacy was assessed and adverse events were recorded. Of 326 subjects enrolled, 251 (77%) completed the study. Subjects received a median of 9 BoNTA treatments (mean dose per session ranged from 148.4 to 213.0 U over a mean of 2.5 years [range: 3.2 months-4.2 years]). Only 4 of 326 subjects (1.2%) tested positive for antibodies in the MPA; three of these subjects stopped responding clinically to BoNTA (of whom one also showed clinical resistance in the FTAT) and one continued to respond. Consistent improvements in the signs/symptoms of CD were noted. The most frequent treatment-related adverse events were mild to moderate weakness, dysphagia, neck pain, and injection-site pain. The current formulation of BoNTA rarely causes neutralizing antibody formation in CD subjects treated ≤4 years.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>États-Unis</li></country><region><li>Bavière</li><li>Californie</li><li>District de Souabe</li><li>Illinois</li><li>Texas</li></region><settlement><li>Augsbourg</li><li>Houston</li></settlement><orgName><li>Baylor College of Medicine</li></orgName></list><tree><country name="États-Unis"><region name="Californie"><name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F." last="Brin">Mitchell F. Brin</name></region><name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F." last="Brin">Mitchell F. Brin</name><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><name sortKey="Lai, Francis" sort="Lai, Francis" uniqKey="Lai F" first="Francis" last="Lai">Francis Lai</name></country><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></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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