title: Real-World, Long-Term Quality of Life Following Therapeutic OnabotulinumtoxinA Treatment.
abstract: BACKGROUND
  OnabotulinumtoxinA is an efficacious treatment option for patients with various conditions. Although studies have reported on the efficacy of onabotulinumtoxinA, quality of life (QoL) data are limited. This study evaluated QoL in patients treated with onabotulinumtoxinA across various therapeutic indications.
  
  
  METHODS
  MDs on BOTOX Utility (MOBILITY) was a prospective, multicenter, observational Canadian study in patients initiating (naïve) or receiving ongoing (maintenance) onabotulinumtoxinA treatment. Health utility was the primary outcome measure and was obtained from the Short Form-12 Health Survey using the Short Form-6D at baseline, week 4 posttreatment, and up to five subsequent treatment visits. The safety cohort included patients who received ≥1 onabotulinumtoxinA treatment.
  
  
  RESULTS
  The efficacy cohort included 1062 patients; the majority were Caucasian, female, and on maintenance onabotulinumtoxinA treatment. Adult focal spasticity (n=398), blepharospasm (n=81), cerebral palsy (n=22), cervical dystonia (n=234), hemifacial spasm (n=116), and hyperhidrosis (n=211) patients were included. Baseline health utility was generally higher in maintenance versus naïve patients; however, naïve patients showed the greatest improvements over time. Health utility was generally maintained or trended toward improvement across all cohorts, including maintenance patients who had been treated for up to 22 years before study entry. Eighteen of 1222 patients (2%) in the safety cohort reported 28 treatment-related adverse events; eight were serious in four patients.
  
  
  CONCLUSIONS
  MOBILITY is the largest prospective study to date to provide QoL data over a variety of therapeutic indications following treatment with onabotulinumtoxinA. Although the QoL burden varies by disease, data suggest that long-term treatment may help improve or maintain QoL over time.
authors.affiliation: 1London Health Sciences Centre,London,Ontario,Canada.
authors.forename: Mandar
authors.initials: M
authors.lastname: Jog
authors.affiliation: 2McGill University,Montreal,Quebec,Canada.
authors.forename: Theodore
authors.initials: T
authors.lastname: Wein
authors.affiliation: 3Allergan Inc.,Markham,Ontario,Canada.
authors.forename: Meetu
authors.initials: M
authors.lastname: Bhogal
authors.affiliation: 3Allergan Inc.,Markham,Ontario,Canada.
authors.forename: Sonja
authors.initials: S
authors.lastname: Dhani
authors.affiliation: 4Dalhousie University,Halifax,Nova Scotia,Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: Miller
authors.affiliation: 5Westpark Healthcare Centre,Toronto,Ontario,Canada.
authors.forename: Farooq
authors.initials: F
authors.lastname: Ismail
authors.affiliation: 6Children's and Women's Health Centre of B.C.,Vancouver,British Columbia,Canada.
authors.forename: Richard
authors.initials: R
authors.lastname: Beauchamp
authors.affiliation: 3Allergan Inc.,Markham,Ontario,Canada.
authors.forename: Grace
authors.initials: G
authors.lastname: Trentin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D065087:Acetylcholine Release Inhibitors / Q000627:therapeutic use; D001764:Blepharospasm / Q000188:drug therapy; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use; D002170:Canada; D002547:Cerebral Palsy / Q000188:drug therapy; D015331:Cohort Studies; D006306:Health Surveys; D019569:Hemifacial Spasm / Q000188:drug therapy; D006945:Hyperhidrosis / Q000188:drug therapy; D009128:Muscle Spasticity / Q000188:drug therapy; D017063:Outcome Assessment, Health Care; D064792:Pragmatic Clinical Trials as Topic; D011788:Quality of Life / Q000523:psychology; D013997:Time Factors; D014103:Torticollis / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A
keywords: Cerebral Palsy; Clinical Trials; Movement Disorders; Quality Of Life; Spasticity