Prospective study evaluating IncobotulinumtoxinA for cervical dystonia or blepharospasm

Interim results from the first 145 subjects with cervical dystonia

Hubert H. Fernandez, Fernando Pagan, Fabio Danisi, David Greeley, Joseph Jankovic, Amit Verma, Kapil Dev Sethi, Eric J. Pappert

Research output: Contribution to journalArticle

Abstract

Background: We report the interim results from XCiDaBLE, a large, prospective, observational "naturalistic" study evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or BLEpharospasm in the United States. Methods: Subjects (≥ 18 years old) with cervical dystonia (CD) are followed for two treatment cycles and monitored via Interactive Voice/Web Response. The subject's physician must have chosen to treat with incobotulinumtoxinA prior to and independent of enrollment in this study. Subject-reported scales include the Subject Global Impression-Severity and Improvement and Cervical Dystonia Impact Profile (CDIP-58), and Work Productivity and Quality of Life (QoL) are assessed by means of an employment questionnaire and work history and the SF-12v2 Health Survey (SF-12v2). Subjects are seen by the investigator for three visits, which include a baseline visit (including the first injection), a second injection visit, and a final study visit (12 weeks after the second injection). Results: This ongoing study includes 145 subjects with a diagnosis of CD. The majority were female (82.3%) and white (91.0%) and had previously been treated with botulinum toxins (77.2%). There were 106 employed at the time of disease onset, but 12.6 years later only 44% were still employed at the time of enrolment into the study, and 20% were either receiving or seeking disability benefits. The mean total dose/treatment of CD was 225.2 units for the first injection. The CDIP-58 total score was significantly improved 4 weeks after the first injection compared to baseline (p≤0.0001). Most subjects noted improvement in their global impression assessment. No new or unexpected adverse events occurred. Discussion: The results from these interim analyses confirm previous controlled, single-dose studies of incobotulinumtoxinA in terms of efficacy and safety.

Original languageEnglish (US)
JournalProceedings of the Royal Society B: Biological Sciences
Volume280
Issue number1760
StatePublished - Jun 7 2013

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Blepharospasm
Torticollis
prospective studies
Prospective Studies
injection
Injections
health survey
disability
quality of life
toxin
safety
productivity
Botulinum Toxins
botulinum toxin
history
observational studies
dosage
Health Surveys
physicians
Productivity

Keywords

  • Botulinum toxin type A
  • CDIP-58
  • Cervical dystonia
  • IncobotulinumtoxinA
  • NT 201

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Microbiology(all)
  • Environmental Science(all)
  • Agricultural and Biological Sciences(all)

Cite this

Prospective study evaluating IncobotulinumtoxinA for cervical dystonia or blepharospasm : Interim results from the first 145 subjects with cervical dystonia. / Fernandez, Hubert H.; Pagan, Fernando; Danisi, Fabio; Greeley, David; Jankovic, Joseph; Verma, Amit; Sethi, Kapil Dev; Pappert, Eric J.

In: Proceedings of the Royal Society B: Biological Sciences, Vol. 280, No. 1760, 07.06.2013.

Research output: Contribution to journalArticle

Fernandez, Hubert H. ; Pagan, Fernando ; Danisi, Fabio ; Greeley, David ; Jankovic, Joseph ; Verma, Amit ; Sethi, Kapil Dev ; Pappert, Eric J. / Prospective study evaluating IncobotulinumtoxinA for cervical dystonia or blepharospasm : Interim results from the first 145 subjects with cervical dystonia. In: Proceedings of the Royal Society B: Biological Sciences. 2013 ; Vol. 280, No. 1760.
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AU - Pagan, Fernando

AU - Danisi, Fabio

AU - Greeley, David

AU - Jankovic, Joseph

AU - Verma, Amit

AU - Sethi, Kapil Dev

AU - Pappert, Eric J.

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AB - Background: We report the interim results from XCiDaBLE, a large, prospective, observational "naturalistic" study evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or BLEpharospasm in the United States. Methods: Subjects (≥ 18 years old) with cervical dystonia (CD) are followed for two treatment cycles and monitored via Interactive Voice/Web Response. The subject's physician must have chosen to treat with incobotulinumtoxinA prior to and independent of enrollment in this study. Subject-reported scales include the Subject Global Impression-Severity and Improvement and Cervical Dystonia Impact Profile (CDIP-58), and Work Productivity and Quality of Life (QoL) are assessed by means of an employment questionnaire and work history and the SF-12v2 Health Survey (SF-12v2). Subjects are seen by the investigator for three visits, which include a baseline visit (including the first injection), a second injection visit, and a final study visit (12 weeks after the second injection). Results: This ongoing study includes 145 subjects with a diagnosis of CD. The majority were female (82.3%) and white (91.0%) and had previously been treated with botulinum toxins (77.2%). There were 106 employed at the time of disease onset, but 12.6 years later only 44% were still employed at the time of enrolment into the study, and 20% were either receiving or seeking disability benefits. The mean total dose/treatment of CD was 225.2 units for the first injection. The CDIP-58 total score was significantly improved 4 weeks after the first injection compared to baseline (p≤0.0001). Most subjects noted improvement in their global impression assessment. No new or unexpected adverse events occurred. Discussion: The results from these interim analyses confirm previous controlled, single-dose studies of incobotulinumtoxinA in terms of efficacy and safety.

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