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Fernandez HH, Jankovic J, Holds JB, et al. Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm. Tremor Other Hyperkinet Mov (N Y). 2014;4:238doi: 10.7916/D8MK6B1B.
Fernandez, H. H., Jankovic, J., Holds, J. B., Lin, D., Burns, J., Verma, A., Sethi, K., & Pappert, E. J. (2014). Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm. Tremor and other hyperkinetic movements (New York, N.Y.), 4238. https://doi.org/10.7916/D8MK6B1B
Fernandez, Hubert H, et al. "Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm." Tremor and other hyperkinetic movements (New York, N.Y.) vol. 4 (2014): 238. doi: https://doi.org/10.7916/D8MK6B1B
Fernandez HH, Jankovic J, Holds JB, Lin D, Burns J, Verma A, Sethi K, Pappert EJ. Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm. Tremor Other Hyperkinet Mov (N Y). 2014 Jul 16;4:238. doi: 10.7916/D8MK6B1B. eCollection 2014. PMID: 25120942; PMCID: PMC4107228.
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Tremor Other Hyperkinet Mov (N Y). 2014 Jul 16;4:238. doi: 10.7916/D8MK6B1B. eCollection 2014.

Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm.

Tremor and other hyperkinetic movements (New York, N.Y.)

Hubert H Fernandez, Joseph Jankovic, John B Holds, Daniel Lin, John Burns, Amit Verma, Kapil Sethi, Eric J Pappert

Affiliations

  1. Cleveland Clinic, Cleveland, OH, USA.
  2. Baylor College of Medicine, Houston, TX, USA.
  3. Ophthalmic Plastic and Cosmetic Surgery, Inc., Des Peres, MO, USA.
  4. Michigan Neuro-ophthalmology & Oculoplastics, PLC, Warren, MI, USA.
  5. Ophthalmic Surgeons and Consultants of Ohio, Columbus, OH, USA.
  6. Merz North America, Inc., Greensboro, NC, USA.
  7. Merz North America, Inc., Greensboro, NC, USA ; Georgia Health Sciences University, Atlanta, GA, USA.
  8. Merz Pharmaceuticals, LLC, Greensboro, NC, USA.

PMID: 25120942 PMCID: PMC4107228 DOI: 10.7916/D8MK6B1B

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.

DISCUSSION: 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.

Keywords: Jankovic Rating Scale; Open label; Xeomin; blepharospasm; incobotulinumtoxinA; prospective

References

  1. Neurology. 2008 May 6;70(19):1699-706 - PubMed
  2. Parkinsonism Relat Disord. 2012 Jun;18(5):441-5 - PubMed
  3. N Engl J Med. 2006 Aug 24;355(8):818-29 - PubMed
  4. Pharmacoeconomics. 1993 Nov;4(5):353-65 - PubMed
  5. Neurotox Res. 2012 Nov;22(4):265-73 - PubMed
  6. J Neural Transm (Vienna). 2011 Feb;118(2):233-9 - PubMed
  7. Tremor Other Hyperkinet Mov (N Y). 2013 May 17;3: - PubMed
  8. Mov Disord. 2011 Jul;26(8):1521-8 - PubMed
  9. Mov Disord. 2009 Feb 15;24(3):407-13 - PubMed
  10. J Infect Dis. 2014 Jan 15;209(2):183-91 - PubMed
  11. J Neural Transm (Vienna). 2013 Sep;120(9):1345-53 - PubMed
  12. J Neural Transm (Vienna). 2006 Mar;113(3):303-12 - PubMed

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