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. 2020 Feb 27:10.
doi: 10.7916/tohm.v0.749. eCollection 2020.

High-dose Botulinum Toxin Therapy: Safety, Benefit, and Endurance of Efficacy

Shannon Y Chiu  1 , Bhavana Patel  1 , Matthew R Burns  1 , Joseph Legacy  1 , Aparna Wagle Shukla  1 , Adolfo Ramirez-Zamora  1 , Wissam Deeb  1 , Irene A Malaty  1
Affiliations

High-dose Botulinum Toxin Therapy: Safety, Benefit, and Endurance of Efficacy

Shannon Y Chiu et al. Tremor Other Hyperkinet Mov (N Y). .

Abstract

Background: Botulinum neurotoxin therapy (BoNT) is a powerful tool for treating many neurologic disorders. The U.S. Food and Drug Administration (FDA)-approved maximum onabotulinum toxin A (OnaA) dose is 400 units (U) per visit, but higher doses are commonly necessary, particularly when treating multiple body regions.

Methods: We collected demographics, OnaA dose, body regions injected and indications, patient-reported efficacy via 7-point Clinical Global Impression Scale (CGIS), and duration of benefit.

Results: Sixty-eight patients were identified receiving OnaA >400 U/session. Dystonia (n = 44) and spasticity (n = 24) were the most common indications for high-dose OnaA. Mean duration of benefit was 9 weeks (standard deviation [SD] 3). More than 70% of patients self-reported "very much improved" or "much improved" at 6 month, 1 year, and last visit. No serious adverse effects were reported.

Discussion: The majority of patients tolerated >400 U OnaA with continued benefit. OnaA doses >400 U may be safe and effective in appropriate patients.

Keywords: Botulinum toxin; dystonia; onabotulinum toxin A; spasticity.

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Conflict of interest statement

Funding: None. Conflicts of Interest: The authors report no conflicts of interest. Ethics Statement: This study was reviewed by the authors’ institutional ethics committee and was considered exempted from further review.

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