Objective: To evaluate the efficacy and safety of the higher dilution rates of Botulinum neurotoxin (BoNT) in focal dystonia.

Background: BoNT is the first line symptomatic treatment of focal dystonia. It is known that dilutation and volume of BoNT preparations have an effect of potency and adverse drug reactions [1]. Compared to the majority of BoNT utilising centres, the outpatient department at the clinic of neurology at Leipzig University Hospital uses a higher dilutation rate for all common BoNT preparations (Leipzig: Abobotulinumtoxin (ABO) 500 mouse units (MU)/10ml, Onabotulinumtoxin (ONA) and Incobotulinumtoxin (INCO) 100 MU/5 ml, most commonly: ABO 500 MU/1-5ml, ONA and INCO 100 MU/1-2.5 ml).

Method: In this observational retrospective study we retrospectively extracted data from reports of our dystonia ambulance of patients with cervical dystonia (CD) and blepharospasm/Meige syndrome (B/M) respectively. The reports contain amongst others the used preparation and dose, clinical scores, subjective patients’ satisfaction and effect duration as well as adverse events.

Results: We included a total of 225 patients, of which 142 had CD and 83 B/M. There was a total of 4985 treatment sessions (CD 3321, B/M 1664). In CD, mean BoNT dose per treatment ± standard deviation of patients treated with ONA was 182.4±50.6 MU, with ABO 414.8±163.3 MU and with INCO 152.8±88.1 MU. In B/M, mean BoNT dose of patients treated with ONA was 63.8±28.3 MU, with ABO 94.7±71.0 MU and with INCO 57.4±36.7 MU. Neither the mean TSUI Score differ between preparations (ONA 6.3±3.0, ABO 6.3±3.1 and INCO 7.2±3.6, p>0.05) nor the mean B/M score (ONA 2.9±1.1, ABO 2.4±1.1 and INCO 2.7±1.2, p>0.05). Mean interval between treatments in CD was longer in the ABO treated patients (CD 95.4±41.2 days, B/M 87.0±27.4) compared to patients treated with ONA (CD 84.9±14.9, B/M  73.3±13.2) and INCO (CD 84.6±11.8, B/M 79.4±12.6; p<0.05). Adverse events did not differ between BoNT preparations and indication.

Conclusion: We could show that the higher BoNT dilution rates used here are efficient and safe. Compared to other BoNT utilising centres [2,3], our dilutation rates can lead to lower BoNT doses. Lower single doses may decrease the risk of developing BoNT antibodies and/or give the opportunity of lower treatment intervals. Further studies in a prospective design will be needed to compare different dilution rates in focal dystonia.

References: [1] Mov Disord. 2013 Nov;28(13):1775-83. doi: 10.1002/mds.25582. Epub 2013 Jul 18. Diffusion, spread, and migration of botulinum toxin. Ramirez-Castaneda J1, Jankovic J, Comella C, Dashtipour K, Fernandez HH, Mari Z.

[2] J Neural Transm (Vienna). 2015 Mar;122(3):427-31. doi: 10.1007/s00702-014-1278-z. Epub 2014 Jul 25. Blepharospasm: long-term treatment with either Botox®, Xeomin® or Dysport®. Kollewe K1, Mohammadi B, Köhler S, Pickenbrock H, Dengler R, Dressler D.

[3] Mov Disord. 2002 Nov;17(6):1288-93. Long-term efficacy of botulinum toxin A in treatment of various movement disorders over a 10-year period. Hsiung GY1, Das SK, Ranawaya R, Lafontaine AL, Suchowersky O

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MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-treatment-with-botulinum-neurotoxin-for-focal-dystonia-effect-of-dose-and-dilution/