Objective: In this prospective, multicenter, non-interventional study (NCT01840462) the primary objective was effectiveness of abobotulinumtoxinA in BoNT treatment-naïve and previously treated subjects after two injection cycles. Secondary objectives included the effectiveness of abobotulinumtoxinA in different CD subtypes.

Background: Cervical dystonia (CD) is a focal dystonia prevalent in roughly 8/100,000 inhabitants, and characterised by involuntary muscle contractions that result in movement and undesired positioning of the head. Depending on the dystonic function of the affected muscles, CD can be further classified by the location (as head or neck type) and the movement (as a turn, shift, or inclination). AbobotulinumtoxinA (Dysport) has been demonstrated to be an effective treatment with a well-established safety profile for CD.

Methods: Subjects received 4 injection cycles (each 3-4 months), with 5 visits (V1-V5), resulting in a 12-16 months study program. Effectiveness was determined using the TSUI score and Quality of Life measures (CDQ-24) with the primary effectiveness variable as the difference of the total TSUI score at visit 1 (V1) and visit 3 (V3).

Results: 361 subjects were enrolled in 41 centers across Germany and Austria. 273 subjects were included in the main analysis population. At baseline, 62.6% had been previously treated with BoNT. The major primary components of CD were torticollis (64.5%) and torticaput (17.6%). Previously treated subjects showed a slight reduction of the TSUI scores (mean V1: 5.6 [SD: 3.3]; mean change V3-V1: -0.3 [SD: 2.4]), whereas BoNT-naïve subjects had a more severe baseline TSUI score (mean V1: 7.8 [SD: 4.2]) and improved much more over all cycles (mean change V3-V1: -2.6 [SD: 4.3]). Results were similar for CDQ-24. Interestingly, improvements mainly occurred in the TSUI subscore A (amplitude of sustained posture) with mean change V3-V1 previously treated: -0.1 [SD: 1.1] and mean change V3-V1 naïve: -1.2 [1.7]. Marked differences between CD subtypes regarding effectiveness could not be determined.

Conclusions: To our knowledge this is the first large multi-centre study investigating and illustrating the effectiveness of BoNT-A in different primary components of CD over several injection cycles.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-german-austrian-multicenter-non-interventional-prospective-study-for-the-treatment-with-abobotulinumtoxina-injections-in-naive-and-previously-treated-patients-suffering-from-cervical-dystonia/