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) |
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Article number | jrm00138 |
Journal | Journal of Rehabilitation Medicine |
Volume | 53 |
Issue number | 1 |
DOIs | |
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