open access

Vol 54, No 1 (2020)
Research Paper
Submitted: 2019-08-14
Accepted: 2020-01-07
Published online: 2020-01-17
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Real-world effectiveness of abobotulinumtoxinA (Dysport®) in adults with upper limb spasticity in routine clinical practice: an observational study

Iwona Sarzyńska-Długosz1, Anna Szczepańska-Szerej2, Artur Drużdż3, Tomasz Łukomski3, Stanisław Ochudło4, Andrzej Fabian5, Piotr Sobolewski6, Katarzyna Mariańska7, Joanna Maciejewska7, Ewa Mulek7, Alina Niedzielska7, Romain Raymond8, Magdalena M. Brzózka9, Maria Jessa-Jabłońska10
·
Pubmed: 31956971
·
Neurol Neurochir Pol 2020;54(1):90-99.
Affiliations
  1. 2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland
  2. Department of Neurology, Medical University of Lublin, Lublin, Poland
  3. Department of Neurology, Municipal Hospital in Poznań, Poznań, Poland
  4. Department of Neurology and Stroke, University Clinical Center, Silesian Medical University, Katowice, Poland
  5. Akson Private Practice, Szczecin, Poland
  6. Collegium Medicum, Jan Kochanowski University in Kielce; Holy Spirit Specialist Hospital in Sandomierz, Sandomierz, Poland
  7. Department of Neurology, Regional Specialist Hospital, Wrocław, Poland
  8. Ividata, Levallois-Perret, France
  9. Ipsen Poland, 29th Jana Pawła II St., 00-867 Warsaw, Poland
  10. Medical Department, Ipsen Poland, Warsaw, Poland

open access

Vol 54, No 1 (2020)
Research papers
Submitted: 2019-08-14
Accepted: 2020-01-07
Published online: 2020-01-17

Abstract

AbobotulinumtoxinA (aboBoNT-A, Dysport®) is used in clinical practice as a well-tolerated and effective therapy for muscle spasticity. AboBoNT-A has been shown to reduce upper and lower limb spastic paresis in clinical trials, demonstrating improvements in muscle tone and limb function. This open-label, multicentre, observational, non-interventional study was the first to investigate aboBoNT-A’s efficacy in adult patients with upper limb spasticity (ULS) in routine clinical practice in Poland. All enrolled patients received ≥1 aboBoNT-A injection cycles, per routine clinical practice (full analysis set, FAS), and ≥1 rehabilitation session. Patients attended a baseline visit (V1) and two follow-up visits (V2, V3) for retreatment, depending on the investigator’s assessment of individual patient needs, with a mean interval (SD) between injections of 4.4 (1.4) and 4.5 (1.2) months. The primary effectiveness endpoint was patient- and physician-based evaluation using the Clinical Global Impression-Improvement Scale (CGII), a validated 7-point scale (1 = very much improved to 7 = very much worse) relative to baseline. CGI-I has not previously been used as a primary endpoint in studies evaluating ULS. Secondary endpoints included muscle tone in shoulder, elbow, carpal joint, and finger muscles, measured by the Modified Ashworth Scale (MAS), and muscle strength according to the Medical Research Council scale (MRC). Of 108 enrolled patients (FAS), 92 (85.2%) completed the study and 57 (52.8%) were included in the per protocol (PP) population. AboBoNT-A improved patient conditions in 96.4% and 98.6% at V2 and V3 (investigator assessment) and 92.8% and 98.6% (as reported by patient) of patients, respectively. Significant reductions in muscle tone from baseline were observed at both visits (p < 0.0001–0.0077) across muscle groups. Increased muscle strength by cumulative MRC was observed at V2 (p = 0.0566) and V3 (p = 0.0282) versus baseline. Safety was consistent with the known profile of aboBoNT-A. In conclusion, aboBoNT-A treatment is beneficial in patients with post-stroke ULS in routine clinical practice, assessed by patients and investigators.

Abstract

AbobotulinumtoxinA (aboBoNT-A, Dysport®) is used in clinical practice as a well-tolerated and effective therapy for muscle spasticity. AboBoNT-A has been shown to reduce upper and lower limb spastic paresis in clinical trials, demonstrating improvements in muscle tone and limb function. This open-label, multicentre, observational, non-interventional study was the first to investigate aboBoNT-A’s efficacy in adult patients with upper limb spasticity (ULS) in routine clinical practice in Poland. All enrolled patients received ≥1 aboBoNT-A injection cycles, per routine clinical practice (full analysis set, FAS), and ≥1 rehabilitation session. Patients attended a baseline visit (V1) and two follow-up visits (V2, V3) for retreatment, depending on the investigator’s assessment of individual patient needs, with a mean interval (SD) between injections of 4.4 (1.4) and 4.5 (1.2) months. The primary effectiveness endpoint was patient- and physician-based evaluation using the Clinical Global Impression-Improvement Scale (CGII), a validated 7-point scale (1 = very much improved to 7 = very much worse) relative to baseline. CGI-I has not previously been used as a primary endpoint in studies evaluating ULS. Secondary endpoints included muscle tone in shoulder, elbow, carpal joint, and finger muscles, measured by the Modified Ashworth Scale (MAS), and muscle strength according to the Medical Research Council scale (MRC). Of 108 enrolled patients (FAS), 92 (85.2%) completed the study and 57 (52.8%) were included in the per protocol (PP) population. AboBoNT-A improved patient conditions in 96.4% and 98.6% at V2 and V3 (investigator assessment) and 92.8% and 98.6% (as reported by patient) of patients, respectively. Significant reductions in muscle tone from baseline were observed at both visits (p < 0.0001–0.0077) across muscle groups. Increased muscle strength by cumulative MRC was observed at V2 (p = 0.0566) and V3 (p = 0.0282) versus baseline. Safety was consistent with the known profile of aboBoNT-A. In conclusion, aboBoNT-A treatment is beneficial in patients with post-stroke ULS in routine clinical practice, assessed by patients and investigators.

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Keywords

botulinum toxin type A, spasticity, upper limb, stroke, observational study

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Title

Real-world effectiveness of abobotulinumtoxinA (Dysport®) in adults with upper limb spasticity in routine clinical practice: an observational study

Journal

Neurologia i Neurochirurgia Polska

Issue

Vol 54, No 1 (2020)

Article type

Research Paper

Pages

90-99

Published online

2020-01-17

Page views

2940

Article views/downloads

2260

DOI

10.5603/PJNNS.a2020.0004

Pubmed

31956971

Bibliographic record

Neurol Neurochir Pol 2020;54(1):90-99.

Keywords

botulinum toxin type A
spasticity
upper limb
stroke
observational study

Authors

Iwona Sarzyńska-Długosz
Anna Szczepańska-Szerej
Artur Drużdż
Tomasz Łukomski
Stanisław Ochudło
Andrzej Fabian
Piotr Sobolewski
Katarzyna Mariańska
Joanna Maciejewska
Ewa Mulek
Alina Niedzielska
Romain Raymond
Magdalena M. Brzózka
Maria Jessa-Jabłońska

References (44)
  1. Esquenazi A, Albanese A, Chancellor MB, et al. Evidence-based review and assessment of botulinum neurotoxin for the treatment of adult spasticity in the upper motor neuron syndrome. Toxicon. 2013; 67: 115–128.
  2. Wallmark S, Ronne-Engström E, Lundström E. Prevalence of spasticity after aneurysmal subarachnoid haemorrhage. J Rehabil Med. 2014; 46(1): 23–27.
  3. Sommerfeld DK, Eek EUB, Svensson AK, et al. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004; 35(1): 134–139.
  4. Kong KH, Lee J, Chua KS. Occurrence and temporal evolution of upper limb spasticity in stroke patients admitted to a rehabilitation unit. Arch Phys Med Rehabil. 2012; 93(1): 143–148.
  5. Urban PP, Wolf T, Uebele M, et al. Occurence and clinical predictors of spasticity after ischemic stroke. Stroke. 2010; 41(9): 2016–2020.
  6. Sławek J, Bogucki A, Budrewicz S, et al. Leczenie toksyną botulinową spastyczności kończyny dolnej po udarze mózgu. Pol Przegl Neurol. 2016; 12(2): 65–79.
  7. Częstość występowania spastyczności u chorych po udarze mózgu. Wpływ spastyczności poudarowej na funkcjonowanie i jakość życia chorego. Gdańsk. ; 2016.
  8. Barnes M, Kocer S, Murie Fernandez M, et al. An international survey of patients living with spasticity. Disabil Rehabil. 2017; 39(14): 1428–1434.
  9. McCrory P, Turner-Stokes L, Baguley IJ, et al. Botulinum toxin A for treatment of upper limb spasticity following stroke: a multi-centre randomized placebo-controlled study of the effects on quality of life and other person-centred outcomes. J Rehabil Med. 2009; 41(7): 536–544.
  10. Schinwelski M, Sławek J. Prevalence of spasticity following stroke and its impact on quality of life with emphasis on disability in activities of daily living. Systematic review. Neurol Neurochir Pol. 2010; 44(4): 404–411.
  11. Shaw L, Rodgers H, Price C, et al. BoTULS investigators. BoTULS: a multicentre randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A. Health Technol Assess. 2010; 14(26): 1–113, iii.
  12. Marciniak C, McAllister P, Walker H, et al. International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group, International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial. Lancet Neurol. 2015; 14(10): 992–1001.
  13. Sławek J. Toksyna botulinowa w leczeniu spastyczności kończyny górnej. Pol Przegl Neurol. 2015; 11(4): 190–201.
  14. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016; 86(19): 1818–1826.
  15. Marciniak C, McAllister P, Walker H, et al. International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin: Subanalysis From a Phase 3 Randomized Controlled Trial. PM R. 2017; 9(12): 1181–1190.
  16. Wissel J, Ward AB, Erztgaard P, et al. European consensus table on the use of botulinum toxin type A in adult spasticity. J Rehabil Med. 2009; 41(1): 13–25.
  17. Royal College of Physicians. Spasticity in adults: management using botulinum toxin. National guidelines 2018: Royal College of Physicians; 2018. Available from:. https://www.rcplondon.ac.uk/guidelines-policy/spasticity-adults-management-using-botulinum-toxin.
  18. Sławek J, Dec-Ćwiek M, Krawczyk M, Drużdż A, Rudzińska M, Ryglewicz D, Sarzyńska-Długosz I. Rekomendacje interdyscyplinarnej grupy ekspertów w zakresie kompleksowego i długofalowego leczenia spastyczności toksyną botulinową typu A. 2018: 47-59.
  19. Truong D, Brodsky M, Lew M, et al. Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010; 16(5): 316–323.
  20. Truong D, Duane DD, Jankovic J, et al. Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Mov Disord. 2005; 20(7): 783–791.
  21. Hauser RA, Truong D, Hubble J, et al. AbobotulinumtoxinA (Dysport) dosing in cervical dystonia: an exploratory analysis of two large open-label extension studies. J Neural Transm (Vienna). 2013; 120(2): 299–307.
  22. Sampaio C, Ferreira JJ, Simões F, et al. DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A--Dysport and Botox--assuming a ratio of 4:1. Mov Disord. 1997; 12(6): 1013–1018.
  23. Durif F. Clinical bioequivalence of the current commercial preparations of botulinum toxin. European Journal of Neurology. 1995; 2: 17–8.
  24. Truong D, Comella C, Fernandez HH, et al. Dysport Benign Essential Blepharospasm Study Group. Efficacy and safety of purified botulinum toxin type A (Dysport) for the treatment of benign essential blepharospasm: a randomized, placebo-controlled, phase II trial. Parkinsonism Relat Disord. 2008; 14(5): 407–414.
  25. Delgado MR, Tilton A, Russman B, et al. AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral Palsy: A Randomized Controlled Trial. Pediatrics. 2016; 137(2): e20152830.
  26. Hyman N, Barnes M, Bhakta B, et al. Botulinum toxin (Dysport) treatment of hip adductor spasticity in multiple sclerosis: a prospective, randomised, double blind, placebo controlled, dose ranging study. J Neurol Neurosurg Psychiatry. 2000; 68(6): 707–712.
  27. Jost WH, Hefter H, Reissig A, et al. Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study. J Neurol Sci. 2014; 337(1-2): 86–90.
  28. Gracies JM, Esquenazi A, Brashear A, et al. International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017; 89(22): 2245–2253.
  29. O'Dell MW, Brashear A, Jech R, et al. Dose-Dependent Effects of AbobotulinumtoxinA (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study. PM R. 2018; 10(1): 1–10.
  30. Marciniak C, McAllister P, Walker H, et al. International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin: Subanalysis From a Phase 3 Randomized Controlled Trial. PM R. 2017; 9(12): 1181–1190.
  31. Gracies JM, O'Dell M, Vecchio M, et al. International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Effects of repeated abobotulinumtoxinA injections in upper limb spasticity. Muscle Nerve. 2018; 57(2): 245–254.
  32. Rosales R, Balcaitiene J, Berard H, et al. Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study. Toxins. 2018; 10(7): 253.
  33. Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007; 4(7): 28–37.
  34. Slawek J, Bogucki A, Reclawowicz D. Botulinum toxin type A for upper limb spasticity following stroke: an open-label study with individualised, flexible injection regimens. Neurol Sci. 2005; 26(1): 32–39.
  35. Wein T, Esquenazi A, Jost WH, et al. OnabotulinumtoxinA for the Treatment of Poststroke Distal Lower Limb Spasticity: A Randomized Trial. PM R. 2018; 10(7): 693–703.
  36. Association IE. Good epidemiological practice: IEA guidelines for proper conduct of epidemiological research. Raleigh. ; 2007.
  37. ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008; 17(2): 200–208.
  38. Ipsen. Dysport Summary of Product Characteristcs (Polish) 2018 [updated 14/06/2018. Available from. https://www.ipsen.pl/websites/IPSENCOM-PROD/wp-content/uploads/sites/8/2016/10/03125344/Dysport_ChPL_14.06.2018.pdf..
  39. Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987; 67(2): 206–207.
  40. Osher JE, Wicklund AH, Rademaker A, et al. The mini-mental state examination in behavioral variant frontotemporal dementia and primary progressive aphasia. Am J Alzheimers Dis Other Demen. 2007; 22(6): 468–473.
  41. Hefter H, Jost WH, Reissig A, et al. Classification of posture in poststroke upper limb spasticity: a potential decision tool for botulinum toxin A treatment? Int J Rehabil Res. 2012; 35(3): 227–233.
  42. Martin A, Abogunrin S, Kurth H, et al. Epidemiological, humanistic, and economic burden of illness of lower limb spasticity in adults: a systematic review. Neuropsychiatr Dis Treat. 2014; 10: 111–122.
  43. Rosales R. Botulinum toxin therapy as an early intervention for post-stroke spasticity: Beyond a functional viewpoint. J Neurol Sci. 2017; 382: 187–188.
  44. Räihä I, Isoaho R, Ojanlatva A, et al. Poor performance in the mini-mental state examination due to causes other than dementia. Scand J Prim Health Care. 2001; 19(1): 34–38.

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