Coleman C, Chang S, Copley-Merriman K, Masaquel CJ, Hubble J. Health-related quality-of-life improvements with dysport in cervical dystonia. Poster presented at the 2011 ISPOR 16th Annual International Meeting; May 26, 2011. [abstract] Value Health. 2011 May; 14(3):A210.

In a multicenter, double-blind trial, Dysport 500 units was compared to placebo in the treatment of cervical dystonia. The primary efficacy response was evaluated using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). Pain was evaluated with the Pain subscale of the TWSTRS and a self-reported pain visual analog scale (VAS). HRQL was assessed using the SF-36 Health Survey (SF-36).

OBJECTIVES: To evaluate improvements in health-related quality of life (HRQL) within patients with cervical dystonia enrolled in a randomized clinical trial with Dysport™ (also known as abobotulinumtoxinA for Injection in the United States).

METHODS: Eighty patients were randomly assigned to receive one treatment with Dysport 500 units or placebo. Participants were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. To evaluate HRQL, changes from baseline to Week 8 on the 8 SF-36 domains, the TWSTRS Pain subscale, and the pain VAS were compared.

RESULTS: TWSTRS total scores were significantly improved with Dysport at weeks 4, 8, and 12 (P 0.013 when compared with placebo). Improvements from baseline to week 8 were seen for all 8 SF-36 domains in the Dysport group. The largest improvements occurred in the Role–Physical and Bodily Pain domains. The placebo group showed some decrease (worsening) in Physical Functioning and little to no change in other SF-36 domains. The differences in mean change scores were statistically significant between the Dysport and placebo for 5 of the 8 domains (Physical Functioning, Role–Physical, Bodily Pain, General Health, and Role–Emotional [P 0.03 for all]). Improvement in the Bodily Pain domain was also supported by significant improvements in the TWSTRS Pain subscale and the pain VAS at week 4.

CONCLUSIONS: The data suggest that HRQL is improved with Dysport, particularly pain improvement and in the SF-36 Physical Functioning and Role–Physical domains.

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