Effects of repeated abobotulinumtoxinA injections in upper limb spasticity

ABSTRACT Introduction: The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year. Methods: Patients (n = 258, safety population) received 500 U,...

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Published inMuscle & nerve Vol. 57; no. 2; pp. 245 - 254
Main Authors Gracies, Jean‐Michel, O'Dell, Michael, Vecchio, Michele, Hedera, Peter, Kocer, Serdar, Rudzinska‐Bar, Monika, Rubin, Bruce, Timerbaeva, Sofiya L., Lusakowska, Anna, Boyer, François Constant, Grandoulier, Anne‐Sophie, Vilain, Claire, Picaut, Philippe
Format Journal Article
LanguageEnglish
Published United States Wiley Subscription Services, Inc 01.02.2018
Wiley
John Wiley and Sons Inc
Subjects
active function
Adult
Adults
Aged
botulinum toxin
Botulinum Toxins, Type A - administration & dosage
Botulinum Toxins, Type A - adverse effects
Botulinum Toxins, Type A - therapeutic use
Clinical Research
Disability Evaluation
Double-Blind Method
Elbow
Elbow (anatomy)
Elbow - physiopathology
Female
Fingers - physiopathology
Flexors
Humans
Injections, Intramuscular
Life Sciences
Male
Middle Aged
Muscle Spasticity - drug therapy
Muscle Spasticity - physiopathology
Muscle Tonus - drug effects
Muscles
Neuromuscular Agents - administration & dosage
Neuromuscular Agents - adverse effects
Neuromuscular Agents - therapeutic use
open label
Range of Motion, Articular - drug effects
Safety
Spasticity
stroke
traumatic brain injury
Treatment Outcome
Upper Extremity - physiopathology
upper limb spasticity
Wrist
Wrist - physiopathology
botulinum toxin
traumatic brain injury
upper limb spasticity
open label
stroke
active function
Online AccessGet full text
ISSN0148-639X
1097-4598
1097-4598
DOI10.1002/mus.25721

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Abstract ABSTRACT Introduction: The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year. Methods: Patients (n = 258, safety population) received 500 U, 1,000 U, or 1,500 U (1,500‐U dose included 500‐U shoulder injections) for up to 4 or 5 treatment cycles. Assessments included treatment‐emergent adverse events (TEAEs), muscle tone, passive and active range of motion (XV1, XA), angle of catch (XV3), Disability Assessment Scale (DAS) score, Modified Frenchay Scale (MFS) score, and Physician Global Assessment (PGA) score. Results: The incidence of TEAEs decreased across cycles. Muscle tone reduction and XV1 remained stable across cycles, whereas XV3 and XA continued to improve at the finger, wrist, and elbow flexors. DAS and PGA improved across cycles. MFS improved best with 1,500 U. Discussion: A favorable safety profile and continuous improvements in active movements and perceived and active function were associated with repeated abobotulinumtoxinA injections in upper limb muscles. Muscle Nerve 57: 245–254, 2018
AbstractList ABSTRACT Introduction : The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year. Methods : Patients ( n = 258, safety population) received 500 U, 1,000 U, or 1,500 U (1,500‐U dose included 500‐U shoulder injections) for up to 4 or 5 treatment cycles. Assessments included treatment‐emergent adverse events (TEAEs), muscle tone, passive and active range of motion (X V1, X A ), angle of catch (X V3 ), Disability Assessment Scale (DAS) score, Modified Frenchay Scale (MFS) score, and Physician Global Assessment (PGA) score. Results : The incidence of TEAEs decreased across cycles. Muscle tone reduction and X V1 remained stable across cycles, whereas X V3 and X A continued to improve at the finger, wrist, and elbow flexors. DAS and PGA improved across cycles. MFS improved best with 1,500 U. Discussion : A favorable safety profile and continuous improvements in active movements and perceived and active function were associated with repeated abobotulinumtoxinA injections in upper limb muscles. Muscle Nerve 57 : 245–254, 2018
The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year. Patients (n = 258, safety population) received 500 U, 1,000 U, or 1,500 U (1,500-U dose included 500-U shoulder injections) for up to 4 or 5 treatment cycles. Assessments included treatment-emergent adverse events (TEAEs), muscle tone, passive and active range of motion (X X ), angle of catch (X ), Disability Assessment Scale (DAS) score, Modified Frenchay Scale (MFS) score, and Physician Global Assessment (PGA) score. The incidence of TEAEs decreased across cycles. Muscle tone reduction and X remained stable across cycles, whereas X and X continued to improve at the finger, wrist, and elbow flexors. DAS and PGA improved across cycles. MFS improved best with 1,500 U. A favorable safety profile and continuous improvements in active movements and perceived and active function were associated with repeated abobotulinumtoxinA injections in upper limb muscles. Muscle Nerve 57: 245-254, 2018.
ABSTRACT Introduction: The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year. Methods: Patients (n = 258, safety population) received 500 U, 1,000 U, or 1,500 U (1,500‐U dose included 500‐U shoulder injections) for up to 4 or 5 treatment cycles. Assessments included treatment‐emergent adverse events (TEAEs), muscle tone, passive and active range of motion (XV1, XA), angle of catch (XV3), Disability Assessment Scale (DAS) score, Modified Frenchay Scale (MFS) score, and Physician Global Assessment (PGA) score. Results: The incidence of TEAEs decreased across cycles. Muscle tone reduction and XV1 remained stable across cycles, whereas XV3 and XA continued to improve at the finger, wrist, and elbow flexors. DAS and PGA improved across cycles. MFS improved best with 1,500 U. Discussion: A favorable safety profile and continuous improvements in active movements and perceived and active function were associated with repeated abobotulinumtoxinA injections in upper limb muscles. Muscle Nerve 57: 245–254, 2018
Introduction: The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year. Methods: Patients (n = 258, safety population) received 500 U, 1,000 U, or 1,500 U (1,500-U dose included 500-U shoulder injections) for up to 4 or 5 treatment cycles. Assessments included treatment-emergent adverse events (TEAEs), muscle tone, passive and active range of motion (XV1, XA), angle of catch (XV3), Disability Assessment Scale (DAS) score, Modified Frenchay Scale (MFS) score, and Physician Global Assessment (PGA) score. Results: The incidence of TEAEs decreased across cycles. Muscle tone reduction and XV1 remained stable across cycles, whereas XV3 and XA continued to improve at the finger, wrist, and elbow flexors. DAS and PGA improved across cycles. MFS improved best with 1,500 U. Discussion: A favorable safety profile and continuous improvements in active movements and perceived and active function were associated with repeated abobotulinumtoxinA injections in upper limb muscles. Muscle Nerve 57: 245-254, 2018
Introduction : The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year. Methods : Patients ( n = 258, safety population) received 500 U, 1,000 U, or 1,500 U (1,500‐U dose included 500‐U shoulder injections) for up to 4 or 5 treatment cycles. Assessments included treatment‐emergent adverse events (TEAEs), muscle tone, passive and active range of motion (X V1, X A ), angle of catch (X V3 ), Disability Assessment Scale (DAS) score, Modified Frenchay Scale (MFS) score, and Physician Global Assessment (PGA) score. Results : The incidence of TEAEs decreased across cycles. Muscle tone reduction and X V1 remained stable across cycles, whereas X V3 and X A continued to improve at the finger, wrist, and elbow flexors. DAS and PGA improved across cycles. MFS improved best with 1,500 U. Discussion : A favorable safety profile and continuous improvements in active movements and perceived and active function were associated with repeated abobotulinumtoxinA injections in upper limb muscles. Muscle Nerve 57 : 245–254, 2018
The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year.INTRODUCTIONThe efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year.Patients (n = 258, safety population) received 500 U, 1,000 U, or 1,500 U (1,500-U dose included 500-U shoulder injections) for up to 4 or 5 treatment cycles. Assessments included treatment-emergent adverse events (TEAEs), muscle tone, passive and active range of motion (XV1, XA ), angle of catch (XV3 ), Disability Assessment Scale (DAS) score, Modified Frenchay Scale (MFS) score, and Physician Global Assessment (PGA) score.METHODSPatients (n = 258, safety population) received 500 U, 1,000 U, or 1,500 U (1,500-U dose included 500-U shoulder injections) for up to 4 or 5 treatment cycles. Assessments included treatment-emergent adverse events (TEAEs), muscle tone, passive and active range of motion (XV1, XA ), angle of catch (XV3 ), Disability Assessment Scale (DAS) score, Modified Frenchay Scale (MFS) score, and Physician Global Assessment (PGA) score.The incidence of TEAEs decreased across cycles. Muscle tone reduction and XV1 remained stable across cycles, whereas XV3 and XA continued to improve at the finger, wrist, and elbow flexors. DAS and PGA improved across cycles. MFS improved best with 1,500 U.RESULTSThe incidence of TEAEs decreased across cycles. Muscle tone reduction and XV1 remained stable across cycles, whereas XV3 and XA continued to improve at the finger, wrist, and elbow flexors. DAS and PGA improved across cycles. MFS improved best with 1,500 U.A favorable safety profile and continuous improvements in active movements and perceived and active function were associated with repeated abobotulinumtoxinA injections in upper limb muscles. Muscle Nerve 57: 245-254, 2018.DISCUSSIONA favorable safety profile and continuous improvements in active movements and perceived and active function were associated with repeated abobotulinumtoxinA injections in upper limb muscles. Muscle Nerve 57: 245-254, 2018.
Author Vecchio, Michele
Hedera, Peter
O'Dell, Michael
Vilain, Claire
Boyer, François Constant
Rubin, Bruce
Picaut, Philippe
Rudzinska‐Bar, Monika
Timerbaeva, Sofiya L.
Gracies, Jean‐Michel
Lusakowska, Anna
Kocer, Serdar
Grandoulier, Anne‐Sophie
AuthorAffiliation 11 Ipsen Innovation Les Ulis France
3 Department of U.O. Physical Medicine and Rehabilitation Policlinico Vittorio Emanuele University Hospital Catania Italy
8 Research Center of Neurology Moscow Russia
4 Department of Neurology Division of Movement Disorders, Vanderbilt University Nashville Tennessee USA
9 Department of Neurology Medical University of Warsaw Poland
1 EA 7377 BIOTN, Université Paris‐Est Créteil Service de Rééducation Neurolocomotrice, Hôpitaux Universitaires Henri Mondor 51, avenue du Maréchal De Lattre De Tassigny, 94010 Créteil France
7 Design Neuroscience Center Doral Florida USA
2 Department of Rehabilitation Medicine Weill Cornell Medicine, Baker Pavilion New York New York USA
5 Centre de Rééducation Hôpital du Jura Porrentruy Switzerland
10 EA 3797, Unités de Médecine Physique et de Réadaptation, Hôpital Universitaire Sébastopol Champagne Ardenne France
6 Department of Neurology Faculty of Medicine, Medical University of Silesia Katowice Poland
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ContentType Journal Article
Copyright 2017 The Authors Muscle & Nerve Published by Wiley Periodicals, Inc.
2018 Wiley Periodicals, Inc.
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Issue 2
Keywords botulinum toxin
traumatic brain injury
upper limb spasticity
open label
stroke
active function
Language English
License Attribution-NonCommercial
http://creativecommons.org/licenses/by-nc/4.0
2017 The Authors Muscle & Nerve Published by Wiley Periodicals, Inc.
Distributed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0
This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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Notes The International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group consists of
Conflicts of Interest
Funding
Journal of Parkinsonism and Restless Legs Syndrome
J.‐M.G. served as a consultant on advisory boards for and received research grant support from Allergan, Ipsen, and Merz. M.O.D. has received grants from and served on the scientific advisory board for Ipsen. M.V. received compensation from Ipsen through his university hospital institution for conducting this clinical trial. P.H. has served on the scientific advisory board of the Spastic Paraplegia Foundation and International Essential Tremor Foundation; has received travel/speaker honoraria from Teva Neuroscience and Lundbeck; has received research support from the National Institute of Neurological Disorders and Stroke; has served as Editor‐in‐chief for the
has served on the editorial boards of
Z. Ayyoub (USA), M. Banach (Poland), D. Bensmail (France), A.R. Bentivoglio (Italy), F.C. Boyer (France), A. Brashear (USA), A. Csanyi (Hungary), T. Deltombe (Belgium), Z. Denes (Hungary), S. Edgley (USA), F. Gul (USA), J.‐M. Gracies (France), P. Hedera (USA), S. Isaacson (USA), M.‐E. Isner‐Horobeti (France), R. Jech (Czech Republic), A. Kaminska (Poland), S. Khatkova (Russia), S. Kocer (France), T. Lejeune (Belgium), P. McAllister (USA), C. Marciniak (USA), P. Marque (France), M. O'Dell (USA), O. Remy‐Neris (France), B. Rubin (USA), M. Rudzinska‐Bar (Poland), D. Simpson (USA), A. Skoromets (Russia), S.L. Timerbaeva (Russia), P. Valkovic (Slovakia), M. Vecchio (Italy), H. Walker (USA), and M. Wimmer (USA).
and has received royalty payments from Elsevier. S.K. has received honoraria from Ipsen for serving as a trainer in multiple programs and as a lecturer. S.K. has also received honoraria from Allergan and Merz for serving as a trainer. M.R.‐B. serves as a primary investigator for Teva Pharmaceutical Industries, Ltd.; Pfizer, Inc.; Acorda Therapeutics, Inc.; and Kyowa Kirin Pharmaceutical Development, Inc.; and receives research support from the Medical University of Silesia and the CHDI Foundation, Inc. B.R. has received research support and speaking and consulting fees from Allergan, Ipsen, and Merz, and physician training for Allergan. S.L.T. has received speaker fees and meeting sponsorship from Ipsen and Merz. A.L. served as a sub‐investigator in clinical trials sponsored by Ipsen, and has received honoraria from Allergan, Merz, and Ipsen for serving as a trainer. F.C.B. served on the scientific advisory board for Ipsen (DOSIS project) and Medtronic, and received research support from the French Muscular Dystrophy Association for developing PRO in muscular dystrophy patients. All non‐Ipsen authors (J.‐M.G., M.O.D., M.V., P.H., S.K., M.R.‐B., B.R., S.L.T., A.L., F.C.B.) received compensation from Ipsen for conducting this clinical trial. A.‐S.G., C.V., and P.P. are employees of Ipsen.
This study was sponsored by Ipsen Innovation, Les Ulis, France.
Neurology, Parkinsonism and Related Disorders
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Conflicts of Interest: J.‐M.G. served as a consultant on advisory boards for and received research grant support from Allergan, Ipsen, and Merz. M.O.D. has received grants from and served on the scientific advisory board for Ipsen. M.V. received compensation from Ipsen through his university hospital institution for conducting this clinical trial. P.H. has served on the scientific advisory board of the Spastic Paraplegia Foundation and International Essential Tremor Foundation; has received travel/speaker honoraria from Teva Neuroscience and Lundbeck; has received research support from the National Institute of Neurological Disorders and Stroke; has served as Editor‐in‐chief for the Journal of Parkinsonism and Restless Legs Syndrome; has served on the editorial boards of Neurology, Parkinsonism and Related Disorders; and has received royalty payments from Elsevier. S.K. has received honoraria from Ipsen for serving as a trainer in multiple programs and as a lecturer. S.K. has also received honoraria from Allergan and Merz for serving as a trainer. M.R.‐B. serves as a primary investigator for Teva Pharmaceutical Industries, Ltd.; Pfizer, Inc.; Acorda Therapeutics, Inc.; and Kyowa Kirin Pharmaceutical Development, Inc.; and receives research support from the Medical University of Silesia and the CHDI Foundation, Inc. B.R. has received research support and speaking and consulting fees from Allergan, Ipsen, and Merz, and physician training for Allergan. S.L.T. has received speaker fees and meeting sponsorship from Ipsen and Merz. A.L. served as a sub‐investigator in clinical trials sponsored by Ipsen, and has received honoraria from Allergan, Merz, and Ipsen for serving as a trainer. F.C.B. served on the scientific advisory board for Ipsen (DOSIS project) and Medtronic, and received research support from the French Muscular Dystrophy Association for developing PRO in muscular dystrophy patients. All non‐Ipsen authors (J.‐M.G., M.O.D., M.V., P.H., S.K., M.R.‐B., B.R., S.L.T., A.L., F.C.B.) received compensation from Ipsen for conducting this clinical trial. A.‐S.G., C.V., and P.P. are employees of Ipsen.
The International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group consists of: Z. Ayyoub (USA), M. Banach (Poland), D. Bensmail (France), A.R. Bentivoglio (Italy), F.C. Boyer (France), A. Brashear (USA), A. Csanyi (Hungary), T. Deltombe (Belgium), Z. Denes (Hungary), S. Edgley (USA), F. Gul (USA), J.‐M. Gracies (France), P. Hedera (USA), S. Isaacson (USA), M.‐E. Isner‐Horobeti (France), R. Jech (Czech Republic), A. Kaminska (Poland), S. Khatkova (Russia), S. Kocer (France), T. Lejeune (Belgium), P. McAllister (USA), C. Marciniak (USA), P. Marque (France), M. O'Dell (USA), O. Remy‐Neris (France), B. Rubin (USA), M. Rudzinska‐Bar (Poland), D. Simpson (USA), A. Skoromets (Russia), S.L. Timerbaeva (Russia), P. Valkovic (Slovakia), M. Vecchio (Italy), H. Walker (USA), and M. Wimmer (USA).
Funding: This study was sponsored by Ipsen Innovation, Les Ulis, France.
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Snippet ABSTRACT Introduction: The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we...
Introduction : The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed...
The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of...
Introduction: The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed...
ABSTRACT Introduction : The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we...
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SubjectTerms active function
Adult
Adults
Aged
botulinum toxin
Botulinum Toxins, Type A - administration & dosage
Botulinum Toxins, Type A - adverse effects
Botulinum Toxins, Type A - therapeutic use
Clinical Research
Disability Evaluation
Double-Blind Method
Elbow
Elbow (anatomy)
Elbow - physiopathology
Female
Fingers - physiopathology
Flexors
Humans
Injections, Intramuscular
Life Sciences
Male
Middle Aged
Muscle Spasticity - drug therapy
Muscle Spasticity - physiopathology
Muscle Tonus - drug effects
Muscles
Neuromuscular Agents - administration & dosage
Neuromuscular Agents - adverse effects
Neuromuscular Agents - therapeutic use
open label
Range of Motion, Articular - drug effects
Safety
Spasticity
stroke
traumatic brain injury
Treatment Outcome
Upper Extremity - physiopathology
upper limb spasticity
Wrist
Wrist - physiopathology
Title Effects of repeated abobotulinumtoxinA injections in upper limb spasticity
URI https://onlinelibrary.wiley.com/doi/abs/10.1002%2Fmus.25721
https://www.ncbi.nlm.nih.gov/pubmed/28590525
https://www.proquest.com/docview/1986926166
https://www.proquest.com/docview/1907003134
https://hal.science/hal-04305908
https://pubmed.ncbi.nlm.nih.gov/PMC5811783
Volume 57
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