Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin Versus Toxin-Naïve Subjects with Cervical Dystonia. (7th May 2013)

• Record Type: Journal Article
• Authors: Fernandez, Hubert H.; Pappert, Eric J.; Comella, Cynthia L.; Evidente, Virgilio Gerald H.; Truong, Daniel D.; Verma, Amit; Jankovic, Joseph
• Editors: Louis, Elan D.
• Is Part Of: Tremor and other hyperkinetic movements. Volume 3(2013)
• Publication Date: 2013-05-07
• Subjects: Botulinum toxin type A -- cervical dystonia -- incobotulinumtoxinA -- pretreated -- treatment-naïve; Tremor -- Periodicals; Hyperkinesia -- Periodicals; 616.8
• Languages: English
• ISSNs: 2160-8288

Abstract

Background: To determine whether botulinum toxin treatment history affected the outcomes of a study comparing the safety and efficacy of incobotulinumtoxinA with placebo in subjects with cervical dystonia (CD). Methods: This was a prospective, double-blind, randomized, placebo-controlled, multicenter trial in botulinum toxin-treated or toxin-naïve CD subjects. Subjects received a fixed dose of either 120 U or 240 U of incobotulinumtoxinA or placebo. The primary outcome measure was change from baseline to Week 4 in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score. Treatment-emergent adverse events (TEAEs) were also evaluated. This report represents a subgroup analysis of botulinum toxin-treated or toxin-naïve subjects. Results: Participants (N = 233; 38.6% toxin-naïve) had a mean age of 52.8 years. IncobotulinumtoxinA significantly improved TWSTRS total scores from baseline to Week 4 in both dose groups versus placebo, and the improvement persisted through the end of the study (≤20 weeks). Both the previously toxin-treated and toxin-naïve subjects demonstrated significant improvements in TWSTRS total scores at Week 4 compared to baseline. The most frequent TEAEs in the incobotulinumtoxinA groups were dysphagia, neck pain, and muscular weakness, which were generally mild. TEAEs were more common in the 240 U group and toxin-naïve subjects. Discussion: Overall, incobotulinumtoxinA was safe and effective in CD, regardless of toxin therapy history. A lower starting dose may be better tolerated among toxin-naïve subjects without sacrificing efficacy.