Primary results from the Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE)

Joseph Jankovic, Charles Howard Adler, David Charles, Cynthia Comella, Mark Stacy, Marc Schwartz, Aubrey Manack Adams, Mitchell F. Brin

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Background The Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE; NCT00836017) is a prospective, observational, multicenter, real-world registry designed to assess the safety, effectiveness, and treatment utilization following multiple treatments of onabotulinumtoxinA. Methods Subjects were naïve to botulinum toxin, new to practice, or had not received toxin in ≤16 weeks if in a clinical trial. Dosages and treatment intervals varied due to the real-world design. Descriptive and inferential statistics evaluated changes over 3 treatments. Results 1046 subjects enrolled. Subjects were 74.4% female, 63.5% toxin-naïve, mean age 58.0 ± 14.7 years. The mean dose over 2481 treatment sessions was 189.8 ± 87.1 U, with average treatment intervals of 14.6 and 15.1 weeks. The mean Toronto Western Spasmodic Torticollis Rating Scale Total score in subjects who completed all assessments (n = 479) decreased from 39.2 at baseline to 27.1 at final visit (P <.0001). A high percentage of physicians reported improvement in Clinician Global Impression of Change after initial assessment; this significantly increased at final assessment (n = 479, 91.2% vs 95.0%; P <.0001). Similarly, a high percentage of subjects reported improvement in Patient Global Impression of Change after initial assessment, which significantly increased at final assessment (n = 470, 83.0% vs 91.7%; P <.0001). Significant reductions in all Cervical Dystonia Impact Profile-58 scores were observed (n = 407). Overall, 26.2% of subjects reported adverse events, including muscular weakness (7.0%) and dysphagia (6.4%). Conclusions Results indicate robust improvement in clinical ratings and excellent tolerability following onabotulinumtoxinA treatment of CD.

Original languageEnglish (US)
Pages (from-to)84-93
Number of pages10
JournalJournal of the Neurological Sciences
Volume349
Issue number1-2
DOIs
StatePublished - Feb 15 2015

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Registries
Torticollis
Observation
Therapeutics
Botulinum Toxins
Muscle Weakness
Deglutition Disorders
onabotulinumtoxinA
Primary Cervical Dystonia
Clinical Trials
Physicians
Safety

Keywords

  • Botulinum toxin
  • Cervical dystonia
  • OnabotulinumtoxinA
  • Pain
  • Torticollis

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Primary results from the Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE). / Jankovic, Joseph; Adler, Charles Howard; Charles, David; Comella, Cynthia; Stacy, Mark; Schwartz, Marc; Manack Adams, Aubrey; Brin, Mitchell F.

In: Journal of the Neurological Sciences, Vol. 349, No. 1-2, 15.02.2015, p. 84-93.

Research output: Contribution to journalArticle

Jankovic, Joseph ; Adler, Charles Howard ; Charles, David ; Comella, Cynthia ; Stacy, Mark ; Schwartz, Marc ; Manack Adams, Aubrey ; Brin, Mitchell F. / Primary results from the Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE). In: Journal of the Neurological Sciences. 2015 ; Vol. 349, No. 1-2. pp. 84-93.
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AU - Jankovic, Joseph

AU - Adler, Charles Howard

AU - Charles, David

AU - Comella, Cynthia

AU - Stacy, Mark

AU - Schwartz, Marc

AU - Manack Adams, Aubrey

AU - Brin, Mitchell F.

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N2 - Background The Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE; NCT00836017) is a prospective, observational, multicenter, real-world registry designed to assess the safety, effectiveness, and treatment utilization following multiple treatments of onabotulinumtoxinA. Methods Subjects were naïve to botulinum toxin, new to practice, or had not received toxin in ≤16 weeks if in a clinical trial. Dosages and treatment intervals varied due to the real-world design. Descriptive and inferential statistics evaluated changes over 3 treatments. Results 1046 subjects enrolled. Subjects were 74.4% female, 63.5% toxin-naïve, mean age 58.0 ± 14.7 years. The mean dose over 2481 treatment sessions was 189.8 ± 87.1 U, with average treatment intervals of 14.6 and 15.1 weeks. The mean Toronto Western Spasmodic Torticollis Rating Scale Total score in subjects who completed all assessments (n = 479) decreased from 39.2 at baseline to 27.1 at final visit (P <.0001). A high percentage of physicians reported improvement in Clinician Global Impression of Change after initial assessment; this significantly increased at final assessment (n = 479, 91.2% vs 95.0%; P <.0001). Similarly, a high percentage of subjects reported improvement in Patient Global Impression of Change after initial assessment, which significantly increased at final assessment (n = 470, 83.0% vs 91.7%; P <.0001). Significant reductions in all Cervical Dystonia Impact Profile-58 scores were observed (n = 407). Overall, 26.2% of subjects reported adverse events, including muscular weakness (7.0%) and dysphagia (6.4%). Conclusions Results indicate robust improvement in clinical ratings and excellent tolerability following onabotulinumtoxinA treatment of CD.

AB - Background The Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE; NCT00836017) is a prospective, observational, multicenter, real-world registry designed to assess the safety, effectiveness, and treatment utilization following multiple treatments of onabotulinumtoxinA. Methods Subjects were naïve to botulinum toxin, new to practice, or had not received toxin in ≤16 weeks if in a clinical trial. Dosages and treatment intervals varied due to the real-world design. Descriptive and inferential statistics evaluated changes over 3 treatments. Results 1046 subjects enrolled. Subjects were 74.4% female, 63.5% toxin-naïve, mean age 58.0 ± 14.7 years. The mean dose over 2481 treatment sessions was 189.8 ± 87.1 U, with average treatment intervals of 14.6 and 15.1 weeks. The mean Toronto Western Spasmodic Torticollis Rating Scale Total score in subjects who completed all assessments (n = 479) decreased from 39.2 at baseline to 27.1 at final visit (P <.0001). A high percentage of physicians reported improvement in Clinician Global Impression of Change after initial assessment; this significantly increased at final assessment (n = 479, 91.2% vs 95.0%; P <.0001). Similarly, a high percentage of subjects reported improvement in Patient Global Impression of Change after initial assessment, which significantly increased at final assessment (n = 470, 83.0% vs 91.7%; P <.0001). Significant reductions in all Cervical Dystonia Impact Profile-58 scores were observed (n = 407). Overall, 26.2% of subjects reported adverse events, including muscular weakness (7.0%) and dysphagia (6.4%). Conclusions Results indicate robust improvement in clinical ratings and excellent tolerability following onabotulinumtoxinA treatment of CD.

KW - Botulinum toxin

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KW - Pain

KW - Torticollis

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