Sustained efficacy of incobotulinumtoxina following repeated injections for upper-limb post-stroke spasticity: A post hoc analysis

Petr Kaňovský; Elie P. Elovic; Michael C. Munin; Angelika Hanschmann; Irena Pulte; Michael Althaus; Reinhard Hiersemenzel; Christina Marciniak

doi:10.2340/16501977-2760

Sustained efficacy of incobotulinumtoxina following repeated injections for upper-limb post-stroke spasticity: A post hoc analysis

Petr Kaňovský^*, Elie P. Elovic, Michael C. Munin, Angelika Hanschmann, Irena Pulte, Michael Althaus, Reinhard Hiersemenzel, Christina Marciniak

^*Corresponding author for this work

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Abstract

Objective: This post hoc analysis assessed the impact of repeated incobotulinumtoxinA injections on muscle tone, disability, and caregiver burden in adults with upper-limb post-stroke spasticity. Design: Data from the double-blind, placebo-controlled main period and three open-label extension cycles of two Phase 3, randomized, multicentre trials were pooled. Methods: Subjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, NCT01392300) or ≤ 400 Units at ≥12-week intervals based on clinical need (study 0410, NCT00432666). Ashworth Scale (AS) arm sumscore (sum of elbow, wrist, finger and thumb flexor, and forearm pronator AS scores), Disability Assessment Scale (DAS), and Carer Burden Scale (CBS) scores were assessed. Results: Among 465 subjects, from study baseline to 4 weeks post-injection, mean (standard deviation) AS arm sumscore improved continuously: main period, -3.23 (2.55) (placebo, -1.49 (2.09)); extension cycles 1, 2, and 3, -4.38 (2.85), -4.87 (3.05), and -5.03 (3.02), respectively. DAS principal target domain responder rate increased from 47.4% in the main period (placebo 27.2%) to 66.6% in extension cycle 3. Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles. Conclusion: IncobotulinumtoxinA conferred sustained improvements in muscle tone, disability, and caregiver burden in subjects with upper-limb poststroke spasticity.

Original language	English (US)
Article number	jrm00138
Journal	Journal of Rehabilitation Medicine
Volume	53
Issue number	1
DOIs	https://doi.org/10.2340/16501977-2760
State	Published - Jan 2021

Funding

The authors wish to thank the subjects and study investigators. Medical writing support, under the direction of the authors, was provided by Claire Cairney, PhD, CMC Connect, McCann Health Medical Communications, and was funded by Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany, in accordance with Good Publication Practice (GPP3) guidelines (31). fee from Desitin/Merz Pharmaceuticals, Medtronic, EverPharma, AbbVie, and fees for participation in the Gedeon Richter Spasticity Advisory Board. EPE: Participated in a Speakers’ Bureau for Ipsen Biopharmaceuticals Inc., and received funding from Merz Pharmaceuticals to participate as coordinating investigator for study 3001. His spouse is an employee of Allergan plc. MCM: Was an advisory board participant for Merz Pharmaceuticals in November 2017. AH: Employee of Merz Pharmaceuticals GmbH. IP: Employee of Merz Pharmaceuticals GmbH. MA: Employee of Merz Pharmaceuticals GmbH. RH: Employee of Merz Pharmaceuticals GmbH. CM: Employed by Shirley Ryan AbilityLab, formerly known as the Rehabilitation Institute of Chicago. This institution received funding from Merz Pharmaceuticals for work performed for study 3001. The Shirley Ryan AbilityLab also receives funding from Ipsen Biopharmaceuticals Inc., and Revance Therapeutics Inc. for Dr Marciniak’s research-related activities.

Keywords

Botulinum neurotoxin
Caregiver burden
Duration of effect
IncobotulinumtoxinA
Rehabilitation
Spasticity
Upper limb

ASJC Scopus subject areas

Rehabilitation
Physical Therapy, Sports Therapy and Rehabilitation

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.2340/16501977-2760

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@article{89d0b2a22f1b4820b97ba92a7facff98,

title = "Sustained efficacy of incobotulinumtoxina following repeated injections for upper-limb post-stroke spasticity: A post hoc analysis",

abstract = "Objective: This post hoc analysis assessed the impact of repeated incobotulinumtoxinA injections on muscle tone, disability, and caregiver burden in adults with upper-limb post-stroke spasticity. Design: Data from the double-blind, placebo-controlled main period and three open-label extension cycles of two Phase 3, randomized, multicentre trials were pooled. Methods: Subjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, NCT01392300) or ≤ 400 Units at ≥12-week intervals based on clinical need (study 0410, NCT00432666). Ashworth Scale (AS) arm sumscore (sum of elbow, wrist, finger and thumb flexor, and forearm pronator AS scores), Disability Assessment Scale (DAS), and Carer Burden Scale (CBS) scores were assessed. Results: Among 465 subjects, from study baseline to 4 weeks post-injection, mean (standard deviation) AS arm sumscore improved continuously: main period, -3.23 (2.55) (placebo, -1.49 (2.09)); extension cycles 1, 2, and 3, -4.38 (2.85), -4.87 (3.05), and -5.03 (3.02), respectively. DAS principal target domain responder rate increased from 47.4% in the main period (placebo 27.2%) to 66.6% in extension cycle 3. Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles. Conclusion: IncobotulinumtoxinA conferred sustained improvements in muscle tone, disability, and caregiver burden in subjects with upper-limb poststroke spasticity.",

keywords = "Botulinum neurotoxin, Caregiver burden, Duration of effect, IncobotulinumtoxinA, Rehabilitation, Spasticity, Upper limb",

author = "Petr Ka{\v n}ovsk{\'y} and Elovic, {Elie P.} and Munin, {Michael C.} and Angelika Hanschmann and Irena Pulte and Michael Althaus and Reinhard Hiersemenzel and Christina Marciniak",

note = "Funding Information: The authors wish to thank the subjects and study investigators. Medical writing support, under the direction of the authors, was provided by Claire Cairney, PhD, CMC Connect, McCann Health Medical Communications, and was funded by Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany, in accordance with Good Publication Practice (GPP3) guidelines (31). Funding Information: fee from Desitin/Merz Pharmaceuticals, Medtronic, EverPharma, AbbVie, and fees for participation in the Gedeon Richter Spasticity Advisory Board. EPE: Participated in a Speakers{\textquoteright} Bureau for Ipsen Biopharmaceuticals Inc., and received funding from Merz Pharmaceuticals to participate as coordinating investigator for study 3001. His spouse is an employee of Allergan plc. MCM: Was an advisory board participant for Merz Pharmaceuticals in November 2017. AH: Employee of Merz Pharmaceuticals GmbH. IP: Employee of Merz Pharmaceuticals GmbH. MA: Employee of Merz Pharmaceuticals GmbH. RH: Employee of Merz Pharmaceuticals GmbH. CM: Employed by Shirley Ryan AbilityLab, formerly known as the Rehabilitation Institute of Chicago. This institution received funding from Merz Pharmaceuticals for work performed for study 3001. The Shirley Ryan AbilityLab also receives funding from Ipsen Biopharmaceuticals Inc., and Revance Therapeutics Inc. for Dr Marciniak{\textquoteright}s research-related activities. Publisher Copyright: {\textcopyright} 2021 Foundation for Rehabilitation Information. All rights reserved.",

year = "2021",

month = jan,

doi = "10.2340/16501977-2760",

language = "English (US)",

volume = "53",

journal = "Journal of Rehabilitation Medicine",

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TY - JOUR

T1 - Sustained efficacy of incobotulinumtoxina following repeated injections for upper-limb post-stroke spasticity

T2 - A post hoc analysis

AU - Kaňovský, Petr

AU - Elovic, Elie P.

AU - Munin, Michael C.

AU - Hanschmann, Angelika

AU - Pulte, Irena

AU - Althaus, Michael

AU - Hiersemenzel, Reinhard

AU - Marciniak, Christina

N1 - Funding Information: The authors wish to thank the subjects and study investigators. Medical writing support, under the direction of the authors, was provided by Claire Cairney, PhD, CMC Connect, McCann Health Medical Communications, and was funded by Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany, in accordance with Good Publication Practice (GPP3) guidelines (31). Funding Information: fee from Desitin/Merz Pharmaceuticals, Medtronic, EverPharma, AbbVie, and fees for participation in the Gedeon Richter Spasticity Advisory Board. EPE: Participated in a Speakers’ Bureau for Ipsen Biopharmaceuticals Inc., and received funding from Merz Pharmaceuticals to participate as coordinating investigator for study 3001. His spouse is an employee of Allergan plc. MCM: Was an advisory board participant for Merz Pharmaceuticals in November 2017. AH: Employee of Merz Pharmaceuticals GmbH. IP: Employee of Merz Pharmaceuticals GmbH. MA: Employee of Merz Pharmaceuticals GmbH. RH: Employee of Merz Pharmaceuticals GmbH. CM: Employed by Shirley Ryan AbilityLab, formerly known as the Rehabilitation Institute of Chicago. This institution received funding from Merz Pharmaceuticals for work performed for study 3001. The Shirley Ryan AbilityLab also receives funding from Ipsen Biopharmaceuticals Inc., and Revance Therapeutics Inc. for Dr Marciniak’s research-related activities. Publisher Copyright: © 2021 Foundation for Rehabilitation Information. All rights reserved.

PY - 2021/1

Y1 - 2021/1

N2 - Objective: This post hoc analysis assessed the impact of repeated incobotulinumtoxinA injections on muscle tone, disability, and caregiver burden in adults with upper-limb post-stroke spasticity. Design: Data from the double-blind, placebo-controlled main period and three open-label extension cycles of two Phase 3, randomized, multicentre trials were pooled. Methods: Subjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, NCT01392300) or ≤ 400 Units at ≥12-week intervals based on clinical need (study 0410, NCT00432666). Ashworth Scale (AS) arm sumscore (sum of elbow, wrist, finger and thumb flexor, and forearm pronator AS scores), Disability Assessment Scale (DAS), and Carer Burden Scale (CBS) scores were assessed. Results: Among 465 subjects, from study baseline to 4 weeks post-injection, mean (standard deviation) AS arm sumscore improved continuously: main period, -3.23 (2.55) (placebo, -1.49 (2.09)); extension cycles 1, 2, and 3, -4.38 (2.85), -4.87 (3.05), and -5.03 (3.02), respectively. DAS principal target domain responder rate increased from 47.4% in the main period (placebo 27.2%) to 66.6% in extension cycle 3. Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles. Conclusion: IncobotulinumtoxinA conferred sustained improvements in muscle tone, disability, and caregiver burden in subjects with upper-limb poststroke spasticity.

AB - Objective: This post hoc analysis assessed the impact of repeated incobotulinumtoxinA injections on muscle tone, disability, and caregiver burden in adults with upper-limb post-stroke spasticity. Design: Data from the double-blind, placebo-controlled main period and three open-label extension cycles of two Phase 3, randomized, multicentre trials were pooled. Methods: Subjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, NCT01392300) or ≤ 400 Units at ≥12-week intervals based on clinical need (study 0410, NCT00432666). Ashworth Scale (AS) arm sumscore (sum of elbow, wrist, finger and thumb flexor, and forearm pronator AS scores), Disability Assessment Scale (DAS), and Carer Burden Scale (CBS) scores were assessed. Results: Among 465 subjects, from study baseline to 4 weeks post-injection, mean (standard deviation) AS arm sumscore improved continuously: main period, -3.23 (2.55) (placebo, -1.49 (2.09)); extension cycles 1, 2, and 3, -4.38 (2.85), -4.87 (3.05), and -5.03 (3.02), respectively. DAS principal target domain responder rate increased from 47.4% in the main period (placebo 27.2%) to 66.6% in extension cycle 3. Significant improvements in CBS scores 4 weeks post-injection accompanied improved functional disability in all cycles. Conclusion: IncobotulinumtoxinA conferred sustained improvements in muscle tone, disability, and caregiver burden in subjects with upper-limb poststroke spasticity.

KW - Botulinum neurotoxin

KW - Caregiver burden

KW - Duration of effect

KW - IncobotulinumtoxinA

KW - Rehabilitation

KW - Spasticity

KW - Upper limb

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U2 - 10.2340/16501977-2760

DO - 10.2340/16501977-2760

M3 - Article

C2 - 33112408

AN - SCOPUS:85099427806

SN - 1650-1977

VL - 53

JO - Journal of Rehabilitation Medicine

JF - Journal of Rehabilitation Medicine

IS - 1

M1 - jrm00138

ER -

Sustained efficacy of incobotulinumtoxina following repeated injections for upper-limb post-stroke spasticity: A post hoc analysis

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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