Movement Disorders (revue)

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Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia

Identifieur interne : 001D47 ( PascalFrancis/Corpus ); précédent : 001D46; suivant : 001D48

Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia

Auteurs : Stewart A. Factor ; Eric S. Molho ; Sharon Evans ; Paul J. Feustel

Source :

RBID : Pascal:05-0493089

Descripteurs français

English descriptors

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 he 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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A08 01  1  ENG  @1 Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia
A11 01  1    @1 FACTOR (Stewart A.)
A11 02  1    @1 MOLHO (Eric S.)
A11 03  1    @1 EVANS (Sharon)
A11 04  1    @1 FEUSTEL (Paul J.)
A14 01      @1 Parkinson's Disease and Movement Disorders Center of Albany Medical Center @2 Albany, New York @3 USA @Z 1 aut. @Z 2 aut. @Z 3 aut.
A14 02      @1 Department of Neurology, Emory University @2 Atlanta, Georgia @3 USA @Z 1 aut.
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C01 01    ENG  @0 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 he 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.
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Format Inist (serveur)

NO : PASCAL 05-0493089 INIST
ET : Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia
AU : FACTOR (Stewart A.); MOLHO (Eric S.); EVANS (Sharon); FEUSTEL (Paul J.)
AF : Parkinson's Disease and Movement Disorders Center of Albany Medical Center/Albany, New York/Etats-Unis (1 aut., 2 aut., 3 aut.); Department of Neurology, Emory University/Atlanta, Georgia/Etats-Unis (1 aut.); Center for Neuropharmacology and Neuroscience, Albany Medical Center, Albany/New York, New York/Etats-Unis (4 aut.)
DT : Publication en série; Niveau analytique
SO : Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2005; Vol. 20; No. 9; Pp. 1152-1160; Bibl. 28 ref.
LA : Anglais
EA : 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 he 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.
CC : 002B17; 002B17H; 002B02C
FD : Système nerveux pathologie; Dystonie; Sécurité; Bontoxilysin
FG : Metalloendopeptidases; Peptidases; Hydrolases; Enzyme; Extrapyramidal syndrome; Mouvement involontaire; Muscle strié pathologie; Trouble neurologique; Encéphale pathologie; Système nerveux central pathologie
ED : Nervous system diseases; Dystonia; Safety; Bontoxilysin
EG : Metalloendopeptidases; Peptidases; Hydrolases; Enzyme; Extrapyramidal syndrome; Involuntary movement; Striated muscle disease; Neurological disorder; Cerebral disorder; Central nervous system disease
SD : Sistema nervioso patología; Distonía; Seguridad; Bontoxilysin
LO : INIST-20953.354000131936030090
ID : 05-0493089

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Pascal:05-0493089

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<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 he 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>
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<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Bontoxilysin</s0>
<s2>FE</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Metalloendopeptidases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Metalloendopeptidases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Metalloendopeptidases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Peptidases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Peptidases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Peptidases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Enzima</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Extrapyramidal syndrome</s0>
<s5>37</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Extrapyramidal syndrome</s0>
<s5>37</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Extrapiramidal síndrome</s0>
<s5>37</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Mouvement involontaire</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Involuntary movement</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Movimiento involuntario</s0>
<s5>38</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE">
<s0>Muscle strié pathologie</s0>
<s5>39</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG">
<s0>Striated muscle disease</s0>
<s5>39</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA">
<s0>Músculo estriado patología</s0>
<s5>39</s5>
</fC07>
<fC07 i1="08" i2="X" l="FRE">
<s0>Trouble neurologique</s0>
<s5>40</s5>
</fC07>
<fC07 i1="08" i2="X" l="ENG">
<s0>Neurological disorder</s0>
<s5>40</s5>
</fC07>
<fC07 i1="08" i2="X" l="SPA">
<s0>Trastorno neurológico</s0>
<s5>40</s5>
</fC07>
<fC07 i1="09" i2="X" l="FRE">
<s0>Encéphale pathologie</s0>
<s5>41</s5>
</fC07>
<fC07 i1="09" i2="X" l="ENG">
<s0>Cerebral disorder</s0>
<s5>41</s5>
</fC07>
<fC07 i1="09" i2="X" l="SPA">
<s0>Encéfalo patología</s0>
<s5>41</s5>
</fC07>
<fC07 i1="10" i2="X" l="FRE">
<s0>Système nerveux central pathologie</s0>
<s5>42</s5>
</fC07>
<fC07 i1="10" i2="X" l="ENG">
<s0>Central nervous system disease</s0>
<s5>42</s5>
</fC07>
<fC07 i1="10" i2="X" l="SPA">
<s0>Sistema nervosio central patología</s0>
<s5>42</s5>
</fC07>
<fN21>
<s1>346</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
<server>
<NO>PASCAL 05-0493089 INIST</NO>
<ET>Efficacy and safety of repeated doses of botulinum toxin type B in type A resistant and responsive cervical dystonia</ET>
<AU>FACTOR (Stewart A.); MOLHO (Eric S.); EVANS (Sharon); FEUSTEL (Paul J.)</AU>
<AF>Parkinson's Disease and Movement Disorders Center of Albany Medical Center/Albany, New York/Etats-Unis (1 aut., 2 aut., 3 aut.); Department of Neurology, Emory University/Atlanta, Georgia/Etats-Unis (1 aut.); Center for Neuropharmacology and Neuroscience, Albany Medical Center, Albany/New York, New York/Etats-Unis (4 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2005; Vol. 20; No. 9; Pp. 1152-1160; Bibl. 28 ref.</SO>
<LA>Anglais</LA>
<EA>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 he 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.</EA>
<CC>002B17; 002B17H; 002B02C</CC>
<FD>Système nerveux pathologie; Dystonie; Sécurité; Bontoxilysin</FD>
<FG>Metalloendopeptidases; Peptidases; Hydrolases; Enzyme; Extrapyramidal syndrome; Mouvement involontaire; Muscle strié pathologie; Trouble neurologique; Encéphale pathologie; Système nerveux central pathologie</FG>
<ED>Nervous system diseases; Dystonia; Safety; Bontoxilysin</ED>
<EG>Metalloendopeptidases; Peptidases; Hydrolases; Enzyme; Extrapyramidal syndrome; Involuntary movement; Striated muscle disease; Neurological disorder; Cerebral disorder; Central nervous system disease</EG>
<SD>Sistema nervioso patología; Distonía; Seguridad; Bontoxilysin</SD>
<LO>INIST-20953.354000131936030090</LO>
<ID>05-0493089</ID>
</server>
</inist>
</record>

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