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Long-Term Abobotulinumtoxin A Treatment of Cervical Dystonia

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Abstract

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.

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Abbreviations

A/Abo:

abobotulinumtoxinA

A/Ona:

onabotulinumtoxinA

BoNT:

botulinum toxin

CD:

cervical dystonia

CGA:

clinical global assessment

DBS:

deep brain stimulation

DRBA:

dopamine receptor blocking agents

EMG:

electromyography

IM:

intramuscular

PCD:

primary cervical dystonia

SD:

standard deviation

SCM:

sternocleidomastoid

SPSS:

Statistical Package for Social Sciences

VAS:

Visual analog scale.

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Acknowledgments

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.

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Author notes

  1. A. R. Bentivoglio and E. Di Stasio equally contributed to the present manuscript.

Authors and Affiliations

  1. Center for Parkinson Disease and Extrapyramidal Disorders, Movement Disorders Unit, Institute of Neurology, Università Cattolica del Sacro Cuore, Largo Agostino Gemelli, 8, 00168, Rome, Italy

    A. R. Bentivoglio, D. Mulas, M. L. Cerbarano, T. Ialongo, A. Laurienzo & Martina Petracca

  2. Fondazione Don Carlo Gnocchi, Milan, Italy

    A. R. Bentivoglio

  3. Institute of Biochemistry and Clinical Biochemistry, Università Cattolica del Sacro Cuore, Rome, Italy

    E. Di Stasio

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  1. A. R. Bentivoglio
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  2. E. Di Stasio
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  4. M. L. Cerbarano
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Correspondence to Martina Petracca.

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Funding

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

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Ethical Approval

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.

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Informed consent was obtained from all individual participants included in the study.

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Bentivoglio, A.R., Di Stasio, E., Mulas, D. et al. Long-Term Abobotulinumtoxin A Treatment of Cervical Dystonia. Neurotox Res 32, 291–300 (2017). https://doi.org/10.1007/s12640-017-9737-6

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