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From Rush University Medical Center (Drs. Comella, Shannon, Leurgans, and Mr. Fan), Chicago, IL; Baylor College of Medicine (Dr. Jankovic), Houston, TX; Vancouver Hospital University of British Columbia (Mr. Tsui), Vancouver, British Columbia, Canada; University of Louisville (Dr. Swenson), Louisville, KY.
Address correspondence and reprint requests to Dr. Cynthia L. Comella, Department of Neurological Sciences, Rush University Medical Center, 1725 West Harrison, Chicago, IL 60612; e-mail: ccomella{at}rush.edu
Objective: To directly compare two serotypes of botulinum toxin (BoNTA and BoNTB) in cervical dystonia (CD) using a randomized, double-blind, parallel-arm study design.
Methods: Subjects with CD who had a previous response from BoNTA were randomly assigned to BoNTA or BoNTB and evaluated in a blinded fashion at baseline, 4 weeks, 8 weeks, and 2-week intervals thereafter until loss of 80% of clinical effect or completion of 20 weeks of observation. CD severity was measured with the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), and adverse events were assessed by structured interview. Statistical analysis included Wilcoxon rank sum test, log rank tests, and Kaplan–Meier survival curves for duration of effect.
Results: A total of 139 subjects (BoNTA, n = 74; BoNTB, n = 65) were randomized at 19 study sites. Improvement in TWSTRS score was found at 4 weeks after injection and did not differ between serotypes. Dysphagia and dry mouth were more frequent with BoNTB (dysphagia: BoNTA 19% vs BoNTB 48%, p = 0.0005; dry mouth (BoNTA 41% vs BoNTB 80%, p < 0.0001). In clinical responders, BoNT A had a modestly longer duration of benefit (BoNTA 14 weeks, BoNTB 12.1 weeks, p = 0.033).
Conclusion: Both serotypes of botulinum toxin (BoNTA and BoNTB) had equivalent benefit in subjects with cervical dystonia at 4 weeks. BoNTA had fewer adverse events and a marginally longer duration of effect in subjects showing a clinical response.
*See Appendix 1 for a list of Group members.
Sponsored by the Dystonia Study Group (DSG). The DSG is solely responsible for the development and implementation of the study protocol. Supported primarily by an unrestricted research grant from Allergan Inc., Irvine, CA.
Disclosure: See full disclosure information in Appendix 2.
Received November 15, 2004. Accepted in final form July 22, 2005.
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Neurology 2005 65: 1344-1345.
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