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

Author:

Albanese Alberto1,Wissel Jörg2ORCID,Jost Wolfgang H.3ORCID,Castagna Anna4,Althaus Michael5,Comes Georg5,Scheschonka Astrid5ORCID,Vacchelli Matteo5,Jinnah Hyder A.6

Affiliation:

1. Department of Neurology, IRCCS Humanitas Research Hospital, 20089 Rozzano, MI, Italy

2. Department of Neurorehabilitation and Physical Therapy, Vivantes Hospital Spandau, 13585 Berlin, Germany

3. Parkinson-Klinik Ortenau, 77709 Wolfach, Germany

4. IRCCS Fondazione Don Carlo Gnocchi, 20148 Milano, MI, Italy

5. Merz Therapeutics GmbH, 60318 Frankfurt am Main, Germany

6. Department of Neurology, Emory University School of Medicine, Atlanta, GA 30322, USA

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.

Funder

Merz Therapeutics GmbH

Publisher

MDPI AG

Subject

Health, Toxicology and Mutagenesis,Toxicology

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