Sustained efficacy of incobotulinumtoxinA (XEOMIN®; botulinum neurotoxin type A, free from complexing proteins) in long-term treatment of cervical dystonia
Germany 
Disclosure : Consultancy fees from Allergan,
Eisai/Soltice, Ipsen, Merz
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16 slide(s) – English – 1999-11-30
Sustained efficacy of incobotulinumtoxinA (XEOMIN®; botulinum neurotoxin type A, free from complexing proteins) in long-term treatment of cervical dystonia
Objective: To assess the long-term efficacy and tolerability of incobotulinumtoxinA in cervical dystonia (CD) in a setting similar to clinical practice.
Methods: In this prospective study (≤121 weeks’ duration), patients with CD received up to five injection series (IS) of incobotulinumtoxinA. The interval between each IS was 10-24 weeks, depending on clinical need. Investigators were free to choose the pattern of muscles injected, number of injection sites and total dose injected (maximum: 300 Units).
Results: Seventy-six patients were enrolled at 17 centres across Germany. Nineteen patients were botulinum toxin treatment naïve, and 57 had received previous injections of botulinum neurotoxin type A. The mean duration of study participation was 64 weeks (range: 49-114 weeks). Mean change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-total score from baseline to 4 weeks after each IS was -11.7 (IS1), 13.6 (IS2), -13.4 (IS3), -13.9 (IS4) and -14.3 (IS5) (data of Full Analysis Set; missing values imputed with LOCF). Similar results were seen with the TWSTRS severity and disability sub-scores. Mean change in Dystonia Discomfort Scale (DDS; a newly developed patient diary) score from baseline to 4 weeks after each IS was 21.1 (IS1), 23.0 (IS2), 20.2 (IS3), 22.2 (IS4) and 21.7 (IS5). Statistical analyses indicated a moderate positive relationship between DDS and TWSTRS-total scores (Bravais Pearson coefficient 0.5482, Spearman coefficient 0.5146). Most treatment related adverse events were mild in severity and none were serious.
Conclusions: IncobotulinumtoxinA showed sustained efficacy with a favourable safety profile in a study of CD with duration up to 121 weeks.
Keywords: botulinum toxin type A; botulinum neurotoxin free from complexing proteins; dystonia; dystonia discomfort scale; incobutulinumtoxinA
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