title: Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm.
abstract: BACKGROUND
  XCiDaBLE is a large, prospective, observational "naturalistic" study evaluating Xeomin® for Cervical Dystonia or BLEpharospasm in the United States. We report the interim results from the blepharospasm cohort of XCiDaBLE.
  
  
  METHODS
  Subjects (≧18 years old) with blepharospasm were followed for two treatment cycles of incobotulinumtoxinA and monitored for 4 weeks after injection via interactive voice/web response system (IVRS/IWRS). The investigator-reported scale includes the Clinical Global Impression Scale-Severity subscale (CGI-S). Patient-reported outcome measures include the Patient Global Impression Scale-Severity (PGI-S) and -Improvement (PGI-I) subscales, Jankovic Rating Scale (JRS), SF-12v2® health survey, and Work Productivity and Activity Impairment questionnaire. Subjects are seen by the investigator at baseline (including the first injection), during the second injection, and at a final study visit (12 weeks after the second injection).
  
  
  RESULTS
  One hundred seventy subjects were included in this interim analysis. The majority of subjects were female (77.1%) and white (91.8%), and had previously been treated with botulinum toxins (96.5%). The mean total dose (both eyes) was 71.5 U of incobotulinumtoxinA for the first injection. PGI-S, PGI-I, and JRS scores were significantly improved 4 weeks after treatment (all p<0.0001). No differences were noted in either quality of life (QoL) or work productivity in this short assessment period. No unexpected adverse events occurred.
  
  
  CONCLUSIONS
  This is an interim study and assessment method based on an IVRS/IWRS. In this predominantly toxin-experienced cohort, significant benefits in specific and global measures of disease severity were seen in the immediate post-incobotulinumtoxinA injection period. It will be interesting to see if there are improvements in QoL with consistent individualized injections over a longer period.
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Hubert H
authors.initials: HH
authors.lastname: Fernandez
authors.affiliation: Baylor College of Medicine, Houston, TX, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Jankovic
authors.affiliation: Ophthalmic Plastic and Cosmetic Surgery, Inc., Des Peres, MO, USA.
authors.forename: John B
authors.initials: JB
authors.lastname: Holds
authors.affiliation: Michigan Neuro-ophthalmology & Oculoplastics, PLC, Warren, MI, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Lin
authors.affiliation: Ophthalmic Surgeons and Consultants of Ohio, Columbus, OH, USA.
authors.forename: John
authors.initials: J
authors.lastname: Burns
authors.affiliation: Merz North America, Inc., Greensboro, NC, USA.
authors.forename: Amit
authors.initials: A
authors.lastname: Verma
authors.affiliation: Merz North America, Inc., Greensboro, NC, USA ; Georgia Health Sciences University, Atlanta, GA, USA.
authors.forename: Kapil
authors.initials: K
authors.lastname: Sethi
authors.affiliation: Merz Pharmaceuticals, LLC, Greensboro, NC, USA.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Pappert
keywords: Jankovic Rating Scale; Open label; Xeomin; blepharospasm; incobotulinumtoxinA; prospective