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

Christina Marciniak, Peter McAllister, Heather Walker, Allison Brashear, Steven Edgley, Thierry Deltombe, Svetlana Khatkova, Marta Banach, Fatma Gul, Claire Vilain, Philippe Picaut, Anne Sophie Grandoulier, Jean Michel Gracies, Z. Ayyoub, M. Banach, D. Bensmail, A. R. Bentivoglio, F. C. Boyer, A. Brashear, A. CsanyiT. Deltombe, Z. Denes, S. Edgley, F. Gul, J. M. Gracies, P. Hedera, S. Isaacson, M. E. Isner-Horobeti, R. Jech, A. Kaminska, S. Khatkova, S. Kocer, T. Lejeune, P. McAllister, C. Marciniak, P. Marque, M. O'Dell, O. Remy-Neris, B. Rubin, M. Rudzinska-Bar, D. Simpson, A. Skoromets, S. L. Timerbaeva, P. Valkovic, M. Vecchio, H. Walker, M. Wimmer

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective: To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A). Design: A post hoc analysis from a Phase 3, prospective, double-blind, randomized, placebo-controlled study (NCT01313299). Setting: A total of 34 neurology or rehabilitation clinics in 9 countries. Participants: Adults aged 18-80 years with hemiparesis, ≥6 months after stroke or traumatic brain injury. This analysis focused on a subgroup of subjects with previous onabotulinumtoxinA or incobotulinumtoxinA treatment (n = 105 of 243 in the total trial population) in the affected limb. The mean age was 52 years, and 62% were male. Intervention: Study subjects were randomized 1:1:1 to receive a single injection session with abobotulinumtoxinA 500 or 1000 U or with placebo in the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and ≥2 additional muscle groups from the upper limb. Main Outcome Measurements: Efficacy and safety measures were assessed, including muscle tone (Modified Ashworth Scale [MAS] in the PTMG), Physician Global Assessment (PGA), perceived function, spasticity, active movement, and treatment-emergent adverse events. Results: At week 4, more subjects had ≥1 grade improvement in MAS for the PTMG with abobotulinumtoxinA versus placebo (abobotulinumtoxinA 500 U, 81.1%; abobotulinumtoxinA 1000 U, 75.0%; placebo, 25.0%). PGA scores ≥1 were achieved by 75.7% and 87.5% of abobotulinumtoxinA 500 and 1000 U subjects versus 41.7% with placebo. Perceived function (Disability Assessment Scale), spasticity angle (Tardieu Scale), and active movement were also improved with abobotulinumtoxinA. There were no treatment-related deaths or serious adverse events. Conclusions: The efficacy and safety of abobotulinumtoxinA in subjects previously treated with BoNT-A were consistent with those in the total trial population. Hence, abobotulinumtoxinA is a treatment option in these patients, and no difference in initial dosing appears to be required compared to that in individuals not treated previously. Level of Evidence: III

Original languageEnglish (US)
Pages (from-to)1181-1190
Number of pages10
JournalPM and R
Volume9
Issue number12
DOIs
StatePublished - Dec 2017
Externally publishedYes

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Botulinum Toxins
Paresis
Upper Extremity
Randomized Controlled Trials
Safety
Muscles
Placebos
Type A Botulinum Toxins
Therapeutics
Physicians
abobotulinumtoxinA
Neurology
Elbow
Wrist
Population
Fingers
Rehabilitation
Extremities
Stroke
Injections

ASJC Scopus subject areas

  • Physical Therapy, Sports Therapy and Rehabilitation
  • Rehabilitation
  • Neurology
  • Clinical Neurology

Cite this

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. / Marciniak, Christina; McAllister, Peter; Walker, Heather; Brashear, Allison; Edgley, Steven; Deltombe, Thierry; Khatkova, Svetlana; Banach, Marta; Gul, Fatma; Vilain, Claire; Picaut, Philippe; Grandoulier, Anne Sophie; Gracies, Jean Michel; Ayyoub, Z.; Banach, M.; Bensmail, D.; Bentivoglio, A. R.; Boyer, F. C.; Brashear, A.; Csanyi, A.; Deltombe, T.; Denes, Z.; Edgley, S.; Gul, F.; Gracies, J. M.; Hedera, P.; Isaacson, S.; Isner-Horobeti, M. E.; Jech, R.; Kaminska, A.; Khatkova, S.; Kocer, S.; Lejeune, T.; McAllister, P.; Marciniak, C.; Marque, P.; O'Dell, M.; Remy-Neris, O.; Rubin, B.; Rudzinska-Bar, M.; Simpson, D.; Skoromets, A.; Timerbaeva, S. L.; Valkovic, P.; Vecchio, M.; Walker, H.; Wimmer, M.

In: PM and R, Vol. 9, No. 12, 12.2017, p. 1181-1190.

Research output: Contribution to journalArticle

Marciniak, C, McAllister, P, Walker, H, Brashear, A, Edgley, S, Deltombe, T, Khatkova, S, Banach, M, Gul, F, Vilain, C, Picaut, P, Grandoulier, AS, Gracies, JM, Ayyoub, Z, Banach, M, Bensmail, D, Bentivoglio, AR, Boyer, FC, Brashear, A, Csanyi, A, Deltombe, T, Denes, Z, Edgley, S, Gul, F, Gracies, JM, Hedera, P, Isaacson, S, Isner-Horobeti, ME, Jech, R, Kaminska, A, Khatkova, S, Kocer, S, Lejeune, T, McAllister, P, Marciniak, C, Marque, P, O'Dell, M, Remy-Neris, O, Rubin, B, Rudzinska-Bar, M, Simpson, D, Skoromets, A, Timerbaeva, SL, Valkovic, P, Vecchio, M, Walker, H & Wimmer, M 2017, '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 and R, vol. 9, no. 12, pp. 1181-1190. https://doi.org/10.1016/j.pmrj.2017.06.007
Marciniak, Christina ; McAllister, Peter ; Walker, Heather ; Brashear, Allison ; Edgley, Steven ; Deltombe, Thierry ; Khatkova, Svetlana ; Banach, Marta ; Gul, Fatma ; Vilain, Claire ; Picaut, Philippe ; Grandoulier, Anne Sophie ; Gracies, Jean Michel ; Ayyoub, Z. ; Banach, M. ; Bensmail, D. ; Bentivoglio, A. R. ; Boyer, F. C. ; Brashear, A. ; Csanyi, A. ; Deltombe, T. ; Denes, Z. ; Edgley, S. ; Gul, F. ; Gracies, J. M. ; Hedera, P. ; Isaacson, S. ; Isner-Horobeti, M. E. ; Jech, R. ; Kaminska, A. ; Khatkova, S. ; Kocer, S. ; Lejeune, T. ; McAllister, P. ; Marciniak, C. ; Marque, P. ; O'Dell, M. ; Remy-Neris, O. ; Rubin, B. ; Rudzinska-Bar, M. ; Simpson, D. ; Skoromets, A. ; Timerbaeva, S. L. ; Valkovic, P. ; Vecchio, M. ; Walker, H. ; Wimmer, M. / 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. In: PM and R. 2017 ; Vol. 9, No. 12. pp. 1181-1190.
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abstract = "Objective: To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A). Design: A post hoc analysis from a Phase 3, prospective, double-blind, randomized, placebo-controlled study (NCT01313299). Setting: A total of 34 neurology or rehabilitation clinics in 9 countries. Participants: Adults aged 18-80 years with hemiparesis, ≥6 months after stroke or traumatic brain injury. This analysis focused on a subgroup of subjects with previous onabotulinumtoxinA or incobotulinumtoxinA treatment (n = 105 of 243 in the total trial population) in the affected limb. The mean age was 52 years, and 62{\%} were male. Intervention: Study subjects were randomized 1:1:1 to receive a single injection session with abobotulinumtoxinA 500 or 1000 U or with placebo in the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and ≥2 additional muscle groups from the upper limb. Main Outcome Measurements: Efficacy and safety measures were assessed, including muscle tone (Modified Ashworth Scale [MAS] in the PTMG), Physician Global Assessment (PGA), perceived function, spasticity, active movement, and treatment-emergent adverse events. Results: At week 4, more subjects had ≥1 grade improvement in MAS for the PTMG with abobotulinumtoxinA versus placebo (abobotulinumtoxinA 500 U, 81.1{\%}; abobotulinumtoxinA 1000 U, 75.0{\%}; placebo, 25.0{\%}). PGA scores ≥1 were achieved by 75.7{\%} and 87.5{\%} of abobotulinumtoxinA 500 and 1000 U subjects versus 41.7{\%} with placebo. Perceived function (Disability Assessment Scale), spasticity angle (Tardieu Scale), and active movement were also improved with abobotulinumtoxinA. There were no treatment-related deaths or serious adverse events. Conclusions: The efficacy and safety of abobotulinumtoxinA in subjects previously treated with BoNT-A were consistent with those in the total trial population. Hence, abobotulinumtoxinA is a treatment option in these patients, and no difference in initial dosing appears to be required compared to that in individuals not treated previously. Level of Evidence: III",
author = "Christina Marciniak and Peter McAllister and Heather Walker and Allison Brashear and Steven Edgley and Thierry Deltombe and Svetlana Khatkova and Marta Banach and Fatma Gul and Claire Vilain and Philippe Picaut and Grandoulier, {Anne Sophie} and Gracies, {Jean Michel} and Z. Ayyoub and M. Banach and D. Bensmail and Bentivoglio, {A. R.} and Boyer, {F. C.} and A. Brashear and A. Csanyi and T. Deltombe and Z. Denes and S. Edgley and F. Gul and Gracies, {J. M.} and P. Hedera and S. Isaacson and Isner-Horobeti, {M. E.} and R. Jech and A. Kaminska and S. Khatkova and S. Kocer and T. Lejeune and P. McAllister and C. Marciniak and P. Marque and M. O'Dell and O. Remy-Neris and B. Rubin and M. Rudzinska-Bar and D. Simpson and A. Skoromets and Timerbaeva, {S. L.} and P. Valkovic and M. Vecchio and H. Walker and M. Wimmer",
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TY - JOUR

T1 - Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin

T2 - Subanalysis From a Phase 3 Randomized Controlled Trial

AU - Marciniak, Christina

AU - McAllister, Peter

AU - Walker, Heather

AU - Brashear, Allison

AU - Edgley, Steven

AU - Deltombe, Thierry

AU - Khatkova, Svetlana

AU - Banach, Marta

AU - Gul, Fatma

AU - Vilain, Claire

AU - Picaut, Philippe

AU - Grandoulier, Anne Sophie

AU - Gracies, Jean Michel

AU - Ayyoub, Z.

AU - Banach, M.

AU - Bensmail, D.

AU - Bentivoglio, A. R.

AU - Boyer, F. C.

AU - Brashear, A.

AU - Csanyi, A.

AU - Deltombe, T.

AU - Denes, Z.

AU - Edgley, S.

AU - Gul, F.

AU - Gracies, J. M.

AU - Hedera, P.

AU - Isaacson, S.

AU - Isner-Horobeti, M. E.

AU - Jech, R.

AU - Kaminska, A.

AU - Khatkova, S.

AU - Kocer, S.

AU - Lejeune, T.

AU - McAllister, P.

AU - Marciniak, C.

AU - Marque, P.

AU - O'Dell, M.

AU - Remy-Neris, O.

AU - Rubin, B.

AU - Rudzinska-Bar, M.

AU - Simpson, D.

AU - Skoromets, A.

AU - Timerbaeva, S. L.

AU - Valkovic, P.

AU - Vecchio, M.

AU - Walker, H.

AU - Wimmer, M.

PY - 2017/12

Y1 - 2017/12

N2 - Objective: To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A). Design: A post hoc analysis from a Phase 3, prospective, double-blind, randomized, placebo-controlled study (NCT01313299). Setting: A total of 34 neurology or rehabilitation clinics in 9 countries. Participants: Adults aged 18-80 years with hemiparesis, ≥6 months after stroke or traumatic brain injury. This analysis focused on a subgroup of subjects with previous onabotulinumtoxinA or incobotulinumtoxinA treatment (n = 105 of 243 in the total trial population) in the affected limb. The mean age was 52 years, and 62% were male. Intervention: Study subjects were randomized 1:1:1 to receive a single injection session with abobotulinumtoxinA 500 or 1000 U or with placebo in the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and ≥2 additional muscle groups from the upper limb. Main Outcome Measurements: Efficacy and safety measures were assessed, including muscle tone (Modified Ashworth Scale [MAS] in the PTMG), Physician Global Assessment (PGA), perceived function, spasticity, active movement, and treatment-emergent adverse events. Results: At week 4, more subjects had ≥1 grade improvement in MAS for the PTMG with abobotulinumtoxinA versus placebo (abobotulinumtoxinA 500 U, 81.1%; abobotulinumtoxinA 1000 U, 75.0%; placebo, 25.0%). PGA scores ≥1 were achieved by 75.7% and 87.5% of abobotulinumtoxinA 500 and 1000 U subjects versus 41.7% with placebo. Perceived function (Disability Assessment Scale), spasticity angle (Tardieu Scale), and active movement were also improved with abobotulinumtoxinA. There were no treatment-related deaths or serious adverse events. Conclusions: The efficacy and safety of abobotulinumtoxinA in subjects previously treated with BoNT-A were consistent with those in the total trial population. Hence, abobotulinumtoxinA is a treatment option in these patients, and no difference in initial dosing appears to be required compared to that in individuals not treated previously. Level of Evidence: III

AB - Objective: To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A). Design: A post hoc analysis from a Phase 3, prospective, double-blind, randomized, placebo-controlled study (NCT01313299). Setting: A total of 34 neurology or rehabilitation clinics in 9 countries. Participants: Adults aged 18-80 years with hemiparesis, ≥6 months after stroke or traumatic brain injury. This analysis focused on a subgroup of subjects with previous onabotulinumtoxinA or incobotulinumtoxinA treatment (n = 105 of 243 in the total trial population) in the affected limb. The mean age was 52 years, and 62% were male. Intervention: Study subjects were randomized 1:1:1 to receive a single injection session with abobotulinumtoxinA 500 or 1000 U or with placebo in the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and ≥2 additional muscle groups from the upper limb. Main Outcome Measurements: Efficacy and safety measures were assessed, including muscle tone (Modified Ashworth Scale [MAS] in the PTMG), Physician Global Assessment (PGA), perceived function, spasticity, active movement, and treatment-emergent adverse events. Results: At week 4, more subjects had ≥1 grade improvement in MAS for the PTMG with abobotulinumtoxinA versus placebo (abobotulinumtoxinA 500 U, 81.1%; abobotulinumtoxinA 1000 U, 75.0%; placebo, 25.0%). PGA scores ≥1 were achieved by 75.7% and 87.5% of abobotulinumtoxinA 500 and 1000 U subjects versus 41.7% with placebo. Perceived function (Disability Assessment Scale), spasticity angle (Tardieu Scale), and active movement were also improved with abobotulinumtoxinA. There were no treatment-related deaths or serious adverse events. Conclusions: The efficacy and safety of abobotulinumtoxinA in subjects previously treated with BoNT-A were consistent with those in the total trial population. Hence, abobotulinumtoxinA is a treatment option in these patients, and no difference in initial dosing appears to be required compared to that in individuals not treated previously. Level of Evidence: III

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