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Author Notes:

Alberto Albanese, alberto.albanese@humanitas.it; Tel.: +39-02-8224-6418

Conceptualization, M.A., G.C., A.S. and M.V.; validation, A.A., J.W., W.H.J., A.C. and H.A.J.; formal analysis, G.C.; resources, M.V.; writing—review and editing, A.A., J.W., W.H.J., A.C., M.A., G.C., A.S., M.V. and H.A.J. All authors have read and agreed to the published version of the manuscript.

The authors wish to acknowledge Deirdre Elmhirst and Gill Gummer (Rx Communications, Mold, UK) for medical writing assistance with the preparation of this manuscript, funded by Merz Therapeutics.

Alberto Albanese has received grants/research support from Boston Scientific and honoraria/consultation fees from Merz Therapeutics and Ipsen. Jörg Wissel has served as an investigator/speaker for AbbVie/Allergan, Ipsen, Medtronic, and Merz, and as an advisor/consultant for AbbVie/Allergan, Ipsen, Medtronic, and Merz. Wolfgang H. Jost is an advisor and speaker for Merz Therapeutics, AbbVie, and Ipsen. Anna Castagna has received speaker honoraria from Merz Therapeutics and Ipsen. Michael Althaus, Georg Comes, Astrid Scheschonka, and Matteo Vacchelli are employees of Merz Therapeutics GmbH. Hyder A. Jinnah has grant support (recent, active, or pending) from the US government (National Institutes of Health [NIH]) and industry (AbbVie, Addex, Aeon, Revance, Sage, and Jazz). He has also served on advisory boards or as a consultant for Addex, AbbVie Apello, CoA Therapeutics, Cavion, Daiichi Sankyo, Ipsen, Jazz, PureTech, Retrophin, Revance, and Takaha/Ene. He has received honoraria or stipends for lectures or administrative work from the International Parkinson′s Disease and Movement Disorders Society. He has also served on scientific advisory boards of several private foundations, including the Benign Essential Blepharospasm Research Foundation, the Dystonia Medical Research Foundation, and the Tourette Association of America. He is also principal investigator for the Dystonia Coalition, which has received most of its support through the NIH (grants NS116025 and NS065701 from the National Institutes of Neurological Disorders and Stroke TR001456 from the Office of Rare Diseases Research at the National Center for Advancing Translational Sciences). The Dystonia Coalition has received additional material or administrative support from industry sponsors (Allergan Inc. and Merz Therapeutics) as well as private foundations (the Benign Essential Blepharospasm Foundation, Cure Dystonia [now, the Dystonia Medical Research Foundation], the National Spasmodic Dysphonia Association, and the National Spasmodic Torticollis Association).

Subject:

Research Funding:

This research was funded by Merz Therapeutics GmbH.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Food Science & Technology
  • Toxicology
  • botulinum toxin type A
  • cervical dystonia
  • incobotulinumtoxinA
  • pain
  • pooled analysis
  • BOTULINUM NEUROTOXIN
  • DOUBLE-BLIND
  • EFFICACY
  • ABOBOTULINUMTOXINA
  • ONABOTULINUMTOXINA
  • DISABILITY
  • XEOMIN(R)
  • PROTEINS
  • SAFETY

Pain Reduction in Cervical Dystonia Following Treatment with IncobotulinumtoxinA: A Pooled Analysis

Tools:

Journal Title:

TOXINS

Volume:

Volume 15, Number 5

Publisher:

Type of Work:

Article | Final Publisher PDF

Abstract:

This analysis pooled pain severity data from four phase 3 and 4 studies of incobotulinumtoxinA (incoBoNT-A) for the treatment of cervical dystonia (CD) in adults. CD-related pain severity was assessed at baseline, each injection visit, and 4 weeks after each injection of incoBoNT-A using the Toronto Western Spasmodic Torticollis Rating Scale pain severity subscale or a pain visual analog scale. Both were analyzed using a score range of 0–10 and pain was categorized as mild, moderate, or severe. Data for 678 patients with pain at baseline were assessed and sensitivity analyses evaluated pain responses in the subgroup not taking concomitant pain medication (n = 384 at baseline). At Week 4 after the first injection, there was a mean change of −1.25 (standard deviation 2.04) points from baseline pain severity (p < 0.0001), with 48.1% showing ≥ 30% pain reduction from baseline, 34.4% showing ≥50% pain reduction from baseline, and 10.3% becoming pain free. Pain responses were sustained over five injection cycles with a trend to incremental improvements with each successive cycle. Pain responses in the subgroup not taking concomitant pain medication demonstrated the lack of confounding effects of pain medications. These results confirmed the pain relief benefits of long-term treatment with incoBoNT-A.

Copyright information:

© 2023 by the authors.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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