Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia.
Identifieur interne : 003147 ( PubMed/Checkpoint ); précédent : 003146; suivant : 003148Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia.
Auteurs : Stewart A. Factor [États-Unis] ; Eric S. Molho ; Sharon Evans ; Paul J. FeustelSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2005.
English descriptors
- KwdEn :
- Botulinum Toxins, Type A (administration & dosage), Botulinum Toxins, Type A (adverse effects), Botulinum Toxins, Type A (therapeutic use), Electromyography, Female, Humans, Injections, Intramuscular, Male, Middle Aged, Neuromuscular Agents (administration & dosage), Neuromuscular Agents (adverse effects), Neuromuscular Agents (therapeutic use), Prospective Studies, Questionnaires, Torticollis (diagnosis), Torticollis (drug therapy), Torticollis (physiopathology).
- MESH :
- chemical , administration & dosage : Botulinum Toxins, Type A, Neuromuscular Agents.
- chemical , adverse effects : Botulinum Toxins, Type A, Neuromuscular Agents.
- chemical , therapeutic use : Botulinum Toxins, Type A, Neuromuscular Agents.
- diagnosis : Torticollis.
- drug therapy : Torticollis.
- physiopathology : Torticollis.
- Electromyography, Female, Humans, Injections, Intramuscular, Male, Middle Aged, Prospective Studies, Questionnaires.
Abstract
Efficacy of botulinum toxin type B (BoNT B) for the treatment of type A-resistant (AR) and non-A-resistant (NAR) cervical dystonia (CD) has been demonstrated in several single injection studies. There is little data available on long-term therapy with repeated injection sessions and it is unknown if AR and NAR patients respond in a similar manner over time. To evaluate the long-term efficacy and safety of BoNT B in AR and NAR CD patients, we carried out a prospective, open-label study examining 10 repeated dosing sessions of BoNT B in 34 patients with CD (15 AR and 19 NAR). Dosing was started at 10,000 units and could be increased to 25,000. Assessments included the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and a patient global assessment at each baseline (injection) and Week 4 (peak effect) visit. Change in TWSTRS total was the primary efficacy end point. Data was analyzed using repeated-measures analysis of variance. BoNT B therapy resulted in an overall significant improvement of CD (P<0.001) and improvement was seen in all 10 individual sessions (2.5 years). The magnitude of response decayed over time (P<0.001). There was no difference between AR and NAR patients with regard to dose, treatment effect, or decay in response. The AR group perceived (patient global) treatment as being less effective (P=0.047). Dry mouth frequency decreased with each session despite increasing doses whereas flu-like syndrome and weakness increased. BoNT B therapy provides long-term benefit for CD patients but the magnitude of response diminishes over time. The cause of this decay is probably multifactorial. AR and NAR CD patients respond in a similar fashion.
DOI: 10.1002/mds.20531
PubMed: 15954134
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia.</title><author><name sortKey="Factor, Stewart A" sort="Factor, Stewart A" uniqKey="Factor S" first="Stewart A" last="Factor">Stewart A. Factor</name><affiliation wicri:level="2"><nlm:affiliation>Parkinson's Disease and Movement Disorders Center of Albany Medical Center, Albany, New York, USA. sfactor@emory.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease and Movement Disorders Center of Albany Medical Center, Albany, New York</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Molho, Eric S" sort="Molho, Eric S" uniqKey="Molho E" first="Eric S" last="Molho">Eric S. Molho</name></author><author><name sortKey="Evans, Sharon" sort="Evans, Sharon" uniqKey="Evans S" first="Sharon" last="Evans">Sharon Evans</name></author><author><name sortKey="Feustel, Paul J" sort="Feustel, Paul J" uniqKey="Feustel P" first="Paul J" last="Feustel">Paul J. Feustel</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2005">2005</date><idno type="doi">10.1002/mds.20531</idno><idno type="RBID">pubmed:15954134</idno><idno type="pmid">15954134</idno><idno type="wicri:Area/PubMed/Corpus">003025</idno><idno type="wicri:Area/PubMed/Curation">003025</idno><idno type="wicri:Area/PubMed/Checkpoint">003147</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia.</title><author><name sortKey="Factor, Stewart A" sort="Factor, Stewart A" uniqKey="Factor S" first="Stewart A" last="Factor">Stewart A. Factor</name><affiliation wicri:level="2"><nlm:affiliation>Parkinson's Disease and Movement Disorders Center of Albany Medical Center, Albany, New York, USA. sfactor@emory.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease and Movement Disorders Center of Albany Medical Center, Albany, New York</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Molho, Eric S" sort="Molho, Eric S" uniqKey="Molho E" first="Eric S" last="Molho">Eric S. Molho</name></author><author><name sortKey="Evans, Sharon" sort="Evans, Sharon" uniqKey="Evans S" first="Sharon" last="Evans">Sharon Evans</name></author><author><name sortKey="Feustel, Paul J" sort="Feustel, Paul J" uniqKey="Feustel P" first="Paul J" last="Feustel">Paul J. Feustel</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="2005" type="published">2005</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Botulinum Toxins, Type A (administration & dosage)</term><term>Botulinum Toxins, Type A (adverse effects)</term><term>Botulinum Toxins, Type A (therapeutic use)</term><term>Electromyography</term><term>Female</term><term>Humans</term><term>Injections, Intramuscular</term><term>Male</term><term>Middle Aged</term><term>Neuromuscular Agents (administration & dosage)</term><term>Neuromuscular Agents (adverse effects)</term><term>Neuromuscular Agents (therapeutic use)</term><term>Prospective Studies</term><term>Questionnaires</term><term>Torticollis (diagnosis)</term><term>Torticollis (drug therapy)</term><term>Torticollis (physiopathology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Botulinum Toxins, Type A</term><term>Neuromuscular Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Botulinum Toxins, Type A</term><term>Neuromuscular Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Botulinum Toxins, Type A</term><term>Neuromuscular Agents</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Torticollis</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Torticollis</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Torticollis</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Electromyography</term><term>Female</term><term>Humans</term><term>Injections, Intramuscular</term><term>Male</term><term>Middle Aged</term><term>Prospective Studies</term><term>Questionnaires</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Efficacy of botulinum toxin type B (BoNT B) for the treatment of type A-resistant (AR) and non-A-resistant (NAR) cervical dystonia (CD) has been demonstrated in several single injection studies. There is little data available on long-term therapy with repeated injection sessions and it is unknown if AR and NAR patients respond in a similar manner over time. To evaluate the long-term efficacy and safety of BoNT B in AR and NAR CD patients, we carried out a prospective, open-label study examining 10 repeated dosing sessions of BoNT B in 34 patients with CD (15 AR and 19 NAR). Dosing was started at 10,000 units and could be increased to 25,000. Assessments included the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and a patient global assessment at each baseline (injection) and Week 4 (peak effect) visit. Change in TWSTRS total was the primary efficacy end point. Data was analyzed using repeated-measures analysis of variance. BoNT B therapy resulted in an overall significant improvement of CD (P<0.001) and improvement was seen in all 10 individual sessions (2.5 years). The magnitude of response decayed over time (P<0.001). There was no difference between AR and NAR patients with regard to dose, treatment effect, or decay in response. The AR group perceived (patient global) treatment as being less effective (P=0.047). Dry mouth frequency decreased with each session despite increasing doses whereas flu-like syndrome and weakness increased. BoNT B therapy provides long-term benefit for CD patients but the magnitude of response diminishes over time. The cause of this decay is probably multifactorial. AR and NAR CD patients respond in a similar fashion.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">15954134</PMID><DateCreated><Year>2005</Year><Month>08</Month><Day>29</Day></DateCreated><DateCompleted><Year>2005</Year><Month>12</Month><Day>20</Day></DateCompleted><DateRevised><Year>2010</Year><Month>11</Month><Day>18</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>20</Volume><Issue>9</Issue><PubDate><Year>2005</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia.</ArticleTitle><Pagination><MedlinePgn>1152-60</MedlinePgn></Pagination><Abstract><AbstractText>Efficacy of botulinum toxin type B (BoNT B) for the treatment of type A-resistant (AR) and non-A-resistant (NAR) cervical dystonia (CD) has been demonstrated in several single injection studies. There is little data available on long-term therapy with repeated injection sessions and it is unknown if AR and NAR patients respond in a similar manner over time. To evaluate the long-term efficacy and safety of BoNT B in AR and NAR CD patients, we carried out a prospective, open-label study examining 10 repeated dosing sessions of BoNT B in 34 patients with CD (15 AR and 19 NAR). Dosing was started at 10,000 units and could be increased to 25,000. Assessments included the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and a patient global assessment at each baseline (injection) and Week 4 (peak effect) visit. Change in TWSTRS total was the primary efficacy end point. Data was analyzed using repeated-measures analysis of variance. BoNT B therapy resulted in an overall significant improvement of CD (P<0.001) and improvement was seen in all 10 individual sessions (2.5 years). The magnitude of response decayed over time (P<0.001). There was no difference between AR and NAR patients with regard to dose, treatment effect, or decay in response. The AR group perceived (patient global) treatment as being less effective (P=0.047). Dry mouth frequency decreased with each session despite increasing doses whereas flu-like syndrome and weakness increased. BoNT B therapy provides long-term benefit for CD patients but the magnitude of response diminishes over time. The cause of this decay is probably multifactorial. 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Feustel</name><name sortKey="Molho, Eric S" sort="Molho, Eric S" uniqKey="Molho E" first="Eric S" last="Molho">Eric S. Molho</name></noCountry><country name="États-Unis"><region name="État de New York"><name sortKey="Factor, Stewart A" sort="Factor, Stewart A" uniqKey="Factor S" first="Stewart A" last="Factor">Stewart A. Factor</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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