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
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ISSN0148-639X
1097-4598
1097-4598
DOI10.1002/mus.25721

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Summary: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
Bibliography: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.
ISSN:0148-639X
1097-4598
1097-4598
DOI:10.1002/mus.25721