Long-Term Abobotulinumtoxin A Treatment of Cervical Dystonia
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Botulinum toxin is considered as first-line therapy for cervical dystonia, but few papers have addressed these issues in the long term. Aim of this study was to investigate the long-term efficacy and safety of abobotulinumtoxin A (A/Abo) in patients with primary cervical dystonia. Consecutive patients who received at least six injections with A/Abo were included. Safety was assessed on patients’ self-reports. Efficacy was assessed by recording the total duration of benefit, duration of maximum efficacy, disease severity measured by means of the Tsui score, and pain intensity evaluated by means of the visual analog scale (VAS). Thirty-nine patients with PCD were included. The mean dose injected was 701.5 ± 280.6 U. The mean duration of the clinical improvement was 93.0 ± 30.7 days, while the mean duration of the maximum clinical improvement was 77.1 ± 27.1 days. The mean VAS before and 4 weeks after injection was 4.4 ± 1.8 and 1.8 ± 1.6, respectively. The mean Tsui score before and 4 weeks after treatment was 5.7 ± 1.8 and 3.5 ± 1.5, respectively. Doses of A/Abo and duration of the maximum clinical improvement significantly increased over time, while the Tsui score and VAS displayed a tendency to decrease along time. Side effects occurred in 19.6% of all the treatments but were severe in only four injections. The results of our study confirm the effectiveness and safety profile of A/Abo for the long-term treatment of primary cervical dystonia.
KeywordsCervical dystonia Botulinum toxin Long-term treatment abobotulinumtoxinA
clinical global assessment
deep brain stimulation
dopamine receptor blocking agents
primary cervical dystonia
Statistical Package for Social Sciences
Visual analog scale.
This study was supported by Ipsen S.p.A Italia. The sponsor provided funding for statistical to perform analysis of data and for an English revision of this paper otherwise the company had no influence on the study protocol, performance of the study, data analysis, or presentation of the results. Ipsen provided a courtesy review of this manuscript. ARB received speaker’s honoraria and a research grant from Ipsen, Merz, Allergan, Chiesi, Lundbeck, UCB and Medtronic. MP received training fees and meeting sponsorship from Ipsen, Merz, Allergan, Chiesi, UCB, ABBVIE. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. The authors alone are responsible for the content of the paper.
Compliance with Ethical Standards
This study was supported by Ipsen S.p.A Italia. The sponsor provided funding for statistical to perform analysis of data and for an English revision of this paper otherwise the company had no influence on the study protocol, performance of the study, data analysis or presentation of the results. Ipsen provided a courtesy review of this manuscript.
Conflicts of Interest
ARB received speaker’s honoraria and a research grant from Ipsen, Merz, Allergan, Chiesi, Lundbeck, UCB and Medtronic. MP received training fees and meeting sponsorship from Ipsen, Merz, Allergan, Chiesi, UCB, ABBVIE. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. The authors alone are responsible for the content of the paper.
Research Involving Human Participants and/or Animals
This was a retrospective longitudinal observational study, conducted in accordance with the Declaration of Helsinki, reviewed and approved by the local ethics committee. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
Informed consent was obtained from all individual participants included in the study.
- Bentivoglio AR, Ialongo T, Bove F, De Nigris F, Fasano A (2012) Retrospective evaluation of the dose equivalence of Botox(®) and Dysport (®) in the management of blepharospasm and hemifacial spasm: a novel paradigm for a never ending story. Neurol Sci 33(2):261–267. doi: 10.1007/s10072-011-0672-7 CrossRefPubMedGoogle Scholar
- Carruthers A, Carruthers J (2007) Eyebrow height after botulinum toxin type A to the glabella. Dermatol Surg 33(1 Spec No.):S26–31Google Scholar
- Charles PD, Manack Adams A, Davis T, Bradley K, Schwartz M, Brin MF, Patel AT (2016) Neck pain and cervical dystonia: treatment outcomes from CD PROBE (cervical dystonia patient registry for observation of OnabotulinumtoxinA efficacy). Pain Pract 16(8):1073–1082Google Scholar
- Defazio G, Jankovic J, Giel JL, Papapetropoulos S (2013) Descriptive epidemiology of cervical dystonia. Tremor Other Hyperkinet Mov (N Y) 4:3Google Scholar
- Jankovic J (2004) Treatment of cervical dystonia. In: Brin M, Comella CL, Jankovic J (eds) Dystonia etiology, clinical features, and treatment. Lippincott Williams & Wilkins, Philadelphia, pp 159–166Google Scholar
- Poewe W, Deuschl G, Nebe A, Feifel E, Wissel J, Benecke R, KR Kessler, Ceballos-Baumann AO, Ohly A, Oertel W, Kunig G (1998) What is the optimal dose of botulinum toxin A in the treatment of cervical dystonia? Results of a double blind, placebo controlled, dose ranging study using DysportÂ. J Neurol Neurosurg Psychiatry 64(1):13–17Google Scholar
- Simpson DM, Blitzer A, Brashear A et al (2008) Assessment: botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the therapeutics and technology assessment Subcommittee of the American Academy of Neurology. Neurology 70:1699–1706CrossRefPubMedGoogle Scholar
- Simpson DM, Hallett M, Ashman EJ et al (2016) Practice guideline update summary: botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: report of the guideline development Subcommittee of the American Academy of Neurology. Neurology 86(19):1818–1826. doi: 10.1212/WNL.0000000000002560 CrossRefPubMedPubMedCentralGoogle Scholar
- Tsui JK, Eisen A, Stoessl AJ, Calne S, Calne DB (1986) Double-Blind Study of Botulinum Toxin in Spasmodic Torticollis. Lancet 2, No.8501, pp. 245–247, ISSN 1474-547XGoogle Scholar
- Wissel J, Kanovsky P, Ruzicka E et al (2001) Efficacy and safety of a standardised 500 unit dose of Dysport (clostridium botulinum toxin type a haemaglutinin complex) in a heterogeneous cervical dystonia population: results of a prospective, multicentre, randomised, double-blind, placebo-controlled, parallel group study. J Neurol 248:1073–1078CrossRefPubMedGoogle Scholar