Objective: To determine if there is a difference in efficacy and duration of effect between high-dose and low-dose botulinumtoxin neurotoxin type-A for cervical dystonia.

Background: Recently, a long-acting neurotoxin, daxibotulinumtoxinA, was approved for cervical dystonia (CD). In their Phase 3 trial, they randomized patients with CD to receive either a low-dose (125 units) or a high-dose (250 units). Surprisingly, the low-dose group had a longer duration of effect (24.0 weeks) compared to the high-dose group (20.3 weeks). We explored whether a similar pattern is seen in other formulations of botulinum neurotoxin type-A (BoNT-A).

Method: Patients with CD who received two consecutive doses of the same cumulative dose of  BoNT-A between August 1, 2022 and December 31, 2023 were included in the study. Patients with a history of essential tremor, who previously received rimabotulinumtoxinB, or received injections for multiple indications, were excluded from the study. The cutoff between low-dose and high-dose groups was 220 units for those who received either onabotulinumtoxinA or incobotulinumtoxinA and 500 units for those who received abobotulinumtoxinA. Outcomes included patient-reported duration of effect and peak dose efficacy at time of follow up. Patient age, duration of illness, and type of neurotoxin were evaluated as potential confounders.

Results: Preliminary data analyses included 79 patients out of which 52 were in the high-dose group and 27 were in the low-dose group. The low-dose group was associated with an increase in the patient-reported duration of effect by 2.64 weeks (95% CI, 2.38-2.90; p-value = 0.01) and an increase in dose efficacy by 7% (95% CI, 6-8%; p-value = 0.02) compared to the high-dose group.

Conclusion: Our preliminary data showed that patients administered a lower dose of BoNT-A reported a longer duration of effect and superior efficacy compared to those who received a higher dose. While a potential explanation for our result is a greater disease burden in patients requiring higher doses, it is also possible that there is a ceiling effect, and we are unnecessarily overdosing patients.

References: Solish, N., Carruthers, J., Kaufman, · Joely, Rubio, R. G., Todd, ·, Gross, M., Conor, ·, Gallagher, J., & Conor, *. (2021). Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A. 81, 2091–2101. https://doi.org/10.1007/s40265-021-01631-w

Study Details | Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1) | ClinicalTrials.gov. (n.d.). Retrieved October 15, 2023, from https://clinicaltrials.gov/study/NCT03608397

Comella, C., Joaquim, ·, Ferreira, J., Pain, E., Azoulai, M., & Om, S. (2021). Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in cervical dystonia. Journal of Neurology, 268, 903–912. https://doi.org/10.1007/s00415-020-10217-7

Dressler, D., Tacik, P., Fereshte, •, & Saberi, A. (n.d.). Botulinum toxin therapy of cervical dystonia: duration of therapeutic effects. https://doi.org/10.1007/s00702-014-1253-8

Marsh, W. A., Monroe, D. M., Brin, M. F., & Gallagher, C. J. (2014). Systematic review and meta-analysis of the duration of clinical effect of onabotulinumtoxinA in cervical dystonia. https://doi.org/10.1186/1471-2377-14-91

Poliziani, M., Koch, M., & Liu, X. (2016). Striving for more good days: patient perspectives on botulinum toxin for the treatment of cervical dystonia. Patient Preference and Adherence, 10, 1601–1608. https://doi.org/10.2147/PPA.S106560

Sethi, K. D., Rodriguez, R., & Olayinka, B. (2012). Satisfaction with botulinum toxin treatment: a cross-sectional survey of patients with cervical dystonia. https://doi.org/10.3111/13696998.2011.653726

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MDS Abstracts - https://www.mdsabstracts.org/abstract/do-lower-doses-of-botulinum-neurotoxin-type-a-offer-a-longer-duration-of-effect-and-superior-efficacy-in-patients-with-cervical-dystonia/