title: 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.
abstract: 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).
  
  
  METHODS
  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.
  
  
  METHODS
  Movement disorder clinics in the USA and Russia.
  
  
  METHODS
  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.
  
  
  METHODS
  Patients were randomised to receive either 500 U abobotulinumtoxinA (n=55) or placebo (n=61).
  
  
  METHODS
  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.
  
  
  BACKGROUND
  The trial is registered at ClinicalTrials.gov, numbers NCT00257660 and NCT00288509.
authors.affiliation: Market Access and Outcomes Strategy, RTI Health Solutions, Ann Arbor, Michigan, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Mordin
authors.affiliation: Market Access and Outcomes Strategy, RTI Health Solutions, Ann Arbor, Michigan, USA.
authors.forename: Catherine
authors.identifier: http://orcid.org/0000-0002-5983-7863
authors.initials: C
authors.lastname: Masaquel
authors.affiliation: Neurology Medical Affairs, Ipsen Biopharmaceuticals Inc, Basking Ridge, New Jersey, USA.
authors.forename: Chandra
authors.initials: C
authors.lastname: Abbott
authors.affiliation: Market Access and Outcomes Strategy, RTI Health Solutions, Ann Arbor, Michigan, USA.
authors.forename: Catherine
authors.initials: C
authors.lastname: Copley-Merriman
mesh_terms: D065087:Acetylcholine Release Inhibitors / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D004421:Dystonia / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006304:Health Status; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009334:Neck Muscles; D019547:Neck Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D017060:Patient Satisfaction; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A; C542869:abobotulinumtoxinA
keywords: QUALITATIVE RESEARCH