Abstract
Introduction
Treatment with botulinum toxin A is the evidence-based first-line therapy of cervical dystonia. The aim of this study was to analyze long-term data of the most commonly used products concerning safety and efficacy in a big cohort over decades.
Methods
We retrospectively analyzed the treatment data of all cervical dystonia patients in our outpatient clinic having at least three treatment sessions with current onabotulinumtoxinA or abobotulinumtoxinA. The observation period was up to 17 years for onabotulinumtoxinA and 27 years for abobotulinumtoxinA. We report on safety and efficacy, comparing parameters such as dose, treatment intervals, side effects, occurrence and reasons of primary or secondary non-response.
Results
We analyzed a total of 2592 and 6660 treatment sessions in 135 patients with onabotulinumtoxinA, 209 with abobotulinumtoxinA and 10 having received both preparations. We found a moderate increase of dosage in the first years which was succeeded by a stable mean dose (138 and 663 mouse units, respectively) and stable injection intervals from the beginning. The most frequent side effects were mild dysphagia (2/6%), muscle weakness (2/6%) and pain (2/2%). Reasons for therapy discontinuation were change to a nearby doctor, age, other diseases, spontaneous improvement, side effects or possible treatment failure. Of all patients, only two tested positive for neutralizing antibodies against botulinum toxin A.
Conclusion
We show that treatment of cervical dystonia with the two most frequently used botulinum toxin A preparations is a safe and effective therapy even over a long treatment duration of up to 27 years.
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Acknowledgements
We thank Rebecca Willnecker, Sophia Schleifer and Korbinian Westphal for their support for the data capture.
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A Jochim has received travel grants from Ipsen Pharma GmbH, Merz Pharmaceuticals GmbH, Pharm-Allergan GmbH, Boston Scientific, Bayer Health and Universitätsklinikum Würzburg as well as speaker honoraria from Pharm-Allergan GmbH. T. Meindl has received travel grants from Ipsen Pharma GmbH, Merz Pharmaceuticals GmbH, Pharm-Allergan GmbH and Boston Scientific Medizintechnik. GmbH. T. Mantel has received travel grants from Bayer Vital GmbH. S. Zwirner has no conflicts of interest. M. Zech is supported by an internal research program at Helmholtz Center Munich, Germany (“Physician Scientists for Groundbreaking Projects”), has received travel expenses from Pharm-Allergan GmbH, and has received speaker honoraria from Bayer Vital GmbH. F. Castrop has no conflicts of interest. B. Haslinger has received research support from the German Research Foundation (DFG), Pharm-Allergan GmbH and Ipsen Pharma GmbH, has received speaker honoraria from Pharm-Allergan GmbH and Bayer Health Care Pharmaceuticals and has received travel grants from Ipsen Pharma GmbH.
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The study has been approved by the local ethics review board. All patients whose data were not only acquired retrospectively, but also recorded prospectively, gave their written informed consent before entering the prospective phase of the study.
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Jochim, A., Meindl, T., Mantel, T. et al. Treatment of cervical dystonia with abo- and onabotulinumtoxinA: long-term safety and efficacy in daily clinical practice. J Neurol 266, 1879–1886 (2019). https://doi.org/10.1007/s00415-019-09349-2
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DOI: https://doi.org/10.1007/s00415-019-09349-2