Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study.

Autor:	Mordin M; Market Access and Outcomes Strategy, RTI Health Solutions, Ann Arbor, Michigan, USA., Masaquel C; Market Access and Outcomes Strategy, RTI Health Solutions, Ann Arbor, Michigan, USA., Abbott C; Neurology Medical Affairs, Ipsen Biopharmaceuticals Inc, Basking Ridge, New Jersey, USA., Copley-Merriman C; Market Access and Outcomes Strategy, RTI Health Solutions, Ann Arbor, Michigan, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2014 Oct 16; Vol. 4 (10), pp. e005150. Date of Electronic Publication: 2014 Oct 16.
DOI:	10.1136/bmjopen-2014-005150
Abstrakt:	Objective: To describe the health-related quality of life (HRQOL) burden of cervical dystonia (CD) and report on the HRQOL and patient perception of treatment benefits of abobotulinumtoxinA (Dysport). Design: The safety and efficacy of a single injection of abobotulinumtoxinA for CD treatment were evaluated in a previously reported international, multicenter, double-blind, randomised trial. HRQOL measures were assessed in the trial and have not been previously reported. Setting: Movement disorder clinics in the USA and Russia. Participants: Patients had to have a diagnosis of CD with symptoms for at least 18 months, as well as a total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score of at least 30; a Severity domain score of at least 15; and a Disability domain score of at least 3. Key exclusion criteria included treatment with botulinum toxin type A (BoNT-A) or botulinum toxin type B (BoNT-B) within 16 weeks of enrolment. Interventions: Patients were randomised to receive either 500 U abobotulinumtoxinA (n=55) or placebo (n=61). Primary and Secondary Outcome Measures: Efficacy assessments included TWSTRS total (primary end point) and subscale scores at weeks 0, 4, 8, 12; a pain visual analogue scale at weeks 0 and 4; and HRQOL assessed by the SF-36 Health Survey (SF-36; secondary end point) at weeks 0 and 8. Results: Patients with CD reported significantly greater impairment for all SF-36 domains relative to US norms. Patients treated with abobotulinumtoxinA reported significantly greater improvements in Physical Functioning, Role Physical, Bodily Pain, General Health and Role Emotional domains than placebo patients (p≤0.03 for all). The TWSTRS was significantly correlated with Physical Functioning, Role Physical and Bodily Pain scores, for those on active treatment. Conclusions: CD has a marked impact on HRQOL. Treatment with a single abobotulinumtoxinA injection results in significant improvement in patients' HRQOL. Trial Registration Number: The trial is registered at ClinicalTrials.gov, numbers NCT00257660 and NCT00288509. (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)
Databáze:	MEDLINE
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