Repeated Treatments With Botulinum Toxin Type A Produce Sustained Decreases in the Limitations Associated With Focal Upper-Limb Poststroke Spasticity for Caregivers and Patients
Presented in part to the American Academy of Physical Medicine and Rehabilitation, October 27–30, 2005, Philadelphia, PA; and the International Conference on the Basic and Therapeutic Aspects of Botulinum and Tetanus Toxins, June 23–25, 2005, Denver, CO.
Abstract
Elovic EP, Brashear A, Kaelin D, Liu J, Millis SR, Barron R, Turkel C. Repeated treatments with botulinum toxin type A produce sustained decreases in the limitations associated with focal upper-limb poststroke spasticity for caregivers and patients.
Objective
To assess the safety and evaluate the effects of repeated treatments with botulinum toxin type A (BTX-A) on functional disability, quality of life (QOL), and muscle tone of patients with upper-limb poststroke spasticity, as well as its effect on caregivers.
Design
Multicenter, open-label, repeated-dose study.
Setting
Thirty-five clinical sites in North America.
Participants
Patients (N=279) with upper-limb poststroke spasticity at 6 months or more poststroke.
Intervention
Up to 5 intramuscular injections of BTX-A (200–400U) divided among the wrist, finger, thumb, and elbow flexors, with at least 200U in the wrist and finger flexors. Retreatment was permitted at 12 weeks or more after the last treatment.
Main Outcome Measures
Investigators rated disability using the Disability Assessment Scale and muscle tone using the Ashworth Scale. Each patient's health-related QOL was assessed by using the Stroke Adapted Sickness Impact Profile and the visual analog scale of the European Quality of Life−5 Dimensions questionnaires.
Results
Patients treated with BTX-A reported improvements in muscle tone, disability, and ability to function that were statistically significant and clinically meaningful. Significant improvements were observed at week 30 and at subsequent time points in QOL in the overall group and the high-dose group.
Conclusions
Up to 5 treatments with BTX-A every 12 weeks for up to 56 weeks in patients with poststroke spasticity was well tolerated and significantly improved muscle tone, lessened disability, and improved patients' QOL. Further research is required to examine the effectiveness of repeated injections of BTX-A in patients with poststroke spasticity.
fDepartment of Physical Medicine and Rehabilitation UMDNJ-NJ Medical School, Newark, NJ
Reprint requests to Elie P. Elovic, MD, 1199 Pleasant Valley Way, West Orange, NJ, 07052
Supported by Allergan Inc.
A commercial party having a direct financial interest in the results of the research supporting this article has conferred or will confer a financial benefit upon the author or one or more of the authors. Elovic has received grant funding from Allergan and Merz, is on the speakers bureau of Allergan, and is on the advisory boards of Allergan, Merz, and Solstice. Brashear has received grant funding from Allergan, Merz, Solstice, and Ipsen and has a consulting agreement with Allergan and Merz. Kaelin has received grant funding from Allergan and is on the speakers bureau of Allergan. Liu was an employee of Allergan and had stock in Allergan at the time the study was conducted. Barron was an employee of Allergan and had stock options in Allergan at the time the study was conducted. Turkel is an employee of Allergan and has both stock and stock options in Allergan. Merz and Ipsen manufacture botulinum toxin type A; Solstice manufactures botulinum toxin type B.
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