Thirty years after their approval, botulinum toxin injections still are the first-line therapy for blepharospasm. The aim of our study was to analyze long-term data concerning safety and efficacy in a large cohort over decades.
Treatment data of all patients with blepharospasm and Meige´s syndrome in our outpatient clinic having undergone at least three subsequent treatment sessions with current onabotulinumtoxinA or abobotulinumtoxin A were analyzed with respect to the course of dose, effect duration, side effects, patients´ satisfaction and occurrence/reasons for treatment discontinuation.
The observation period was up to 18 years for onabotulinumtoxinA and 29 years for abobotulinumtoxinA with a total of 1778 and 9319 treatment sessions in 69 patients with onabotulinumtoxinA, 281 with abobotulinumtoxin A and 2 of these having used both products. The dose increased in the first years followed by a stable dose in the following years. The mean dose was 39.1/198.7 mouse units (onabotulinumtoxinA/abobotulinumtoxinA). In over 25% of all sessions, inhibition of the eyelid opening was effectively treated with pretarsal injections. The most common adverse events included ptosis (4%/5%), epiphora/sicca (4%/5%), double vision (1%/1%) and facial asymmetry (1%/1%). Reasons for therapy discontinuation were change to a nearby doctor, age, other diseases, spontaneous improvement, side effects or possible treatment failure. Only one patient was tested positive for neutralizing antibodies against botulinum toxin A.
The treatment of blepharospasm and Meige’s syndrome with onabotulinumtoxinA and abobotulinumtoxinA is safe and effective, also over a long observation period of up to 29 years.
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Conflicts of interest:
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. C. Huber has no conflicts of interest. T. Mantel has received travel grants from Bayer Vital GmbH. S. Zwirner has no conflicts of interest. 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.
The study has been approved by the local ethics review board and has, therefore, been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. 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., Huber, C. et al. Treatment of blepharospasm and Meige’s syndrome with abo- and onabotulinumtoxinA: long-term safety and efficacy in daily clinical practice. J Neurol 267, 267–275 (2020). https://doi.org/10.1007/s00415-019-09581-w
- Orofacial dystonia
- Meige’s syndrome
- Long-term treatment
- Botulinum toxin A