Optimal Muscle Selection for OnabotulinumtoxinA Injections in Post-stroke Lower-Limb Spasticity: A Randomized Trial

OBJECTIVE To identify optimal muscle selection patterns for onabotulinumtoxinA treatment of post-stroke lower-limb spasticity (PSLLS). DESIGN Adults with PSLLS (ankle Modified Ashworth Scale [MAS] ≥3) were randomized to onabotulinumtoxinA (300 U, mandatory ankle plantar flexors; ≤100 U, optional lower-limb muscles) or placebo. Post hoc analysis assessed the impact of muscle selection patterns on ankle MAS and physician-assessed Clinical Global Impression of Change (CGI) based on change from baseline to average of weeks 4/6 versus placebo. RESULTS Among 468 patients randomized, onabotulinumtoxinA improved ankle MAS (–0.81 vs –0.61; P=0.01) and CGI (0.86 vs 0.65; P=0.012) versus placebo. Injection of mandatory muscles alone was not sufficient in improving ankle MAS (P=0.255) or CGI (P=0.576) versus placebo but was adequate ≤24 months post-stroke (MAS, –1.13 vs –0.62, P=0.019; CGI, 1.24 vs 0.68, P=0.006). Additional injections into toe muscles (flexor digitorum longus, flexor hallucis longus) improved ankle MAS (–0.98 vs –0.52; P=0.002) and CGI (0.80 vs 0.38; P=0.023) versus placebo regardless of time since stroke. OnabotulinumtoxinA was well tolerated, with no new safety findings. CONCLUSIONS Post hoc analyses suggested additional injections of onabotulinumtoxinA into toe flexors improved ankle MAS and CGI scores versus mandatory muscles alone overall and with treatment initiation >24 months post-stroke. Address correspondence to: Alberto Esquenazi, MD, Department of Physical Medicine and Rehabilitation, MossRehab Gait and Motion Analysis Laboratory, 60 Township Line Road, Elkins Park, PA 19027. Phone: 215-663-6676. Fax: 215-663-6686. aesquena@einstein.edu Disclosures: Competing Interests: Alberto Esquenazi, MD: Dr Esquenazi has received research support from and acted as a consultant for Allergan and Ipsen. Theodore H. Wein, MD, FRCPC: Dr Wein has received research funds from Allergan plc, Merz, National Institutes of Health, Accorda, and Boehringer Ingelheim; acted as a consultant for Allergan plc and Ispen; and received honoraria for accredited CME from Bayer and Boehringer Ingelheim. Anthony B. Ward, MD, FRCP: Dr Ward is a speaker and consultant for Allergan plc and Ipsen. Carolyn Geis, MD: Dr Geis has received research support from and is a speaker/consultant for Allergan plc. Chengcheng Liu, PhD, and Rozalina Dimitrova, MD, MPH, are employees of Allergan plc and Rozalina Dimitrova holds stock in the company. Study funding: This study and analysis were sponsored by Allergan plc (Dublin, Ireland). The study sponsor was involved in the study design, data collection, data analysis, data interpretation, and writing of the article. Assistance with medical writing was provided by Complete Healthcare Communications, LLC (West Chester, PA). Details of Previous Presentations: The REFLEX Study subanalysis on muscle selection patterns for onabotulinumtoxinA has been presented at the following conferences: Wein T, Esquenazi A, Ward A, Geis C, Liu C, Dimitrova R. Muscle Selection Patterns for Injection of OnabotulinumtoxinA in Adult Patients With Post-Stroke Lower-Limb Spasticity Influence Outcome: Results From a Double-Blind, Placebo-Controlled Phase 3 Clinical Trial. American Academy of Neurology 2016 - 68th Annual Meeting. 2016. Wein T, Esquenazi A, Ward A, Geis C, Liu C, Dimitrova R. Muscle Selection Patterns for Injection of OnabotulinumtoxinA in Adult Patients With Post-Stroke Lower-Limb Spasticity Influence Outcome: Results From a Double-Blind, Placebo-Controlled Phase 3 Clinical Trial. World Federation for NeuroRehabilitation - 9th World Congress for NeuroRehabilitation. 2016. Wein T, Esquenazi A, Ward A, Geis C, Liu C, Dimitrova R. Muscle Selection Patterns for Injection of OnabotulinumtoxinA in Adult Patients With Post-Stroke Lower-Limb Spasticity Influence Outcome: Results From a Double-Blind, Placebo-Controlled Phase 3 Clinical Trial. Movement Disorder Society - 20th International Congress of Parkinson's Disease and Movement Disorder. 2016. Wein T, Esquenazi A, Ward A, Geis C, Liu C, Dimitrova R. Muscle Selection Patterns for Injection of OnabotulinumtoxinA in Adult Patients With Post-Stroke Lower-Limb Spasticity Influence Outcome: Results From a Double-Blind, Placebo-Controlled Phase 3 Clinical Trial. American Academy of Physical Medicine and Rehabilitation. 2016. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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