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Efficacy of botulinum toxin type B (rimabotulinumtoxinB) in patients with cervical dystonia previously treated with botulinum toxin type A: A post-marketing observational study in Japan

ABSTRACT: To date, efficacy data on botulinum toxin type B (rimabotulinumtoxinB) in patients with cervical dystonia (CD) previously treated with botulinum toxin type A in a large population are lacking; thus, we aimed to evaluate type B efficacy in this patient population. In a post-marketing observational cohort study, 150 patients previously treated with botulinum toxin type A were enrolled, of whom 138 were followed up for 1 year after the initial type B injection. Final observation data were available for 122 patients. Efficacy was evaluated using the Toronto Western Spasmodic Torticollis Rating Scale. Total score improved from 39.9 at baseline to 34.3 at 4 weeks after the first injection, and pain score improved from 8.9 to 7.9. Improvements were maintained through six further injections in two subpopulations: patients who showed resistance to botulinum toxin type A and patients who were not type A resistant but switched to type B. For a number of patients, even low doses (<5000 units) of botulinum toxin type B demonstrated efficacy. These findings support the efficacy of botulinum toxin type B in clinical settings for the management of CD symptoms, including pain, even at low doses, regardless of the patient's botulinum toxin type A resistance status. Highlights • Botulinum toxin type B improved cervical dystonia symptoms and pain after 4 weeks.• Botulinum toxin type B was effective even at low doses (<5000 units).• The efficacy of toxin type B is not affected by toxin type A resistance status.

SUBMITTER: Kaji R

PROVIDER: S-EPMC8627969 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin Versus Toxin-Naive Subjects with Cervical Dystonia.

Project description: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). 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. 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. 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.

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Factors influencing response to Botulinum toxin type A in patients with idiopathic cervical dystonia: results from an international observational study.

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Botulinum Toxin Type A Injection for Cervical Dystonia in Adults with Dyskinetic Cerebral Palsy.

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