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

• Type of Material: Article
• Authors: Alberto Albanese, IRCCS Humanitas Research Hospital; Jörg Wissel, Vivantes Hospital Spandau; Wolfgang H Jost, Parkinson Klin Ortenau; Anna Castagna, IRCCS Fondazione Don Carlo Gnocchi; Michael Althaus, Merz Therapeutics GmbH; Georg Comes, Merz Therapeutics GmbH; Astrid Scheschonka, Merz Therapeutics GmbH; Matteo Vacchelli, Merz Therapeutics GmbH; Hyder Jinnah, Emory University
• Language: English
• Date: 2023-05-12
• Publisher: MDPI
• Publication Version: Final Published Version
• Copyright Statement: © 2023 by the authors.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.3390/toxins15050333
• Title of Journal or Parent Work: TOXINS
• Volume: 15
• Issue: 5
• Grant/Funding Information: This research was funded by Merz Therapeutics GmbH.
• Keywords: incobotulinumtoxinA; cervical dystonia; DISABILITY; pain; ABOBOTULINUMTOXINA; Food Science & Technology; botulinum toxin type A; BOTULINUM NEUROTOXIN; Life Sciences & Biomedicine; ONABOTULINUMTOXINA; Toxicology; pooled analysis; SAFETY; PROTEINS; DOUBLE-BLIND; Science & Technology; EFFICACY; XEOMIN(R)
• Research Categories: Health Sciences, Medicine and Surgery

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.