Long‐term treatment with botulinum toxin type A in cervical dystonia has low immunogenicity by mouse protection assay
Identifieur interne : 002779 ( Main/Exploration ); précédent : 002778; suivant : 002780Long‐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 ] ; 2008-07-30.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Animal, Animals, Antibodies, Bacterial (biosynthesis), Antibodies, Bacterial (immunology), Antibody Specificity, Biological Assay, Bontoxilysin, Botulinum Toxins, Type A (administration & dosage), Botulinum Toxins, Type A (adverse effects), Botulinum Toxins, Type A (immunology), Botulinum Toxins, Type A (therapeutic use), Dystonia, Female, Follow-Up Studies, Humans, Immunogenicity, Injections, Intramuscular, Long term, Male, Mice, Middle Aged, Mouse, Nervous system diseases, Neutralization Tests, Prospective Studies, Torticollis (drug therapy), Torticollis (immunology), Treatment, antigenicity, botulinum toxin, cervical dystonia, immunogenicity, neutralizing antibodies.
- MESH :
- chemical , administration & dosage : Botulinum Toxins, Type A.
- chemical , adverse effects : Botulinum Toxins, Type A.
- chemical , biosynthesis : Antibodies, Bacterial.
- chemical , immunology : Antibodies, Bacterial, Botulinum Toxins, Type A.
- chemical , therapeutic use : Botulinum Toxins, Type A.
- drug therapy : Torticollis.
- immunology : Torticollis.
- Adult, Aged, Aged, 80 and over, Animals, Antibody Specificity, Biological Assay, Female, Follow-Up Studies, Humans, Injections, Intramuscular, Male, Mice, Middle Aged, Neutralization Tests, Prospective Studies.
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 naïve to BoNTs were treated with BoNTA in a prospective, open‐label, multicenter 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. © 2008 Movement Disorder Society
Url:
DOI: 10.1002/mds.22157
Affiliations:
- Allemagne, États-Unis
- Bavière, Californie, District de Souabe, Illinois, Texas
- Augsbourg, Houston
- Baylor College of Medicine
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Le document en format XML
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<term>Animals</term>
<term>Antibodies, Bacterial (biosynthesis)</term>
<term>Antibodies, Bacterial (immunology)</term>
<term>Antibody Specificity</term>
<term>Biological Assay</term>
<term>Bontoxilysin</term>
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<term>Botulinum Toxins, Type A (adverse effects)</term>
<term>Botulinum Toxins, Type A (immunology)</term>
<term>Botulinum Toxins, Type A (therapeutic use)</term>
<term>Dystonia</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Immunogenicity</term>
<term>Injections, Intramuscular</term>
<term>Long term</term>
<term>Male</term>
<term>Mice</term>
<term>Middle Aged</term>
<term>Mouse</term>
<term>Nervous system diseases</term>
<term>Neutralization Tests</term>
<term>Prospective Studies</term>
<term>Torticollis (drug therapy)</term>
<term>Torticollis (immunology)</term>
<term>Treatment</term>
<term>antigenicity</term>
<term>botulinum toxin</term>
<term>cervical dystonia</term>
<term>immunogenicity</term>
<term>neutralizing antibodies</term>
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<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Botulinum Toxins, Type A</term>
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<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Animals</term>
<term>Antibody Specificity</term>
<term>Biological Assay</term>
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<term>Follow-Up Studies</term>
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<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 naïve to BoNTs were treated with BoNTA in a prospective, open‐label, multicenter 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. © 2008 Movement Disorder Society</div>
</front>
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