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 language | English (US) |
|---|---|
| Pages (from-to) | 84-93 |
| Number of pages | 10 |
| Journal | Journal of the Neurological Sciences |
| Volume | 349 |
| Issue number | 1-2 |
| DOIs | |
| State | Published - Feb 15 2015 |
Fingerprint
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 journal › Article
}
TY - JOUR
T1 - Primary results from the Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE)
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.
PY - 2015/2/15
Y1 - 2015/2/15
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
KW - Cervical dystonia
KW - OnabotulinumtoxinA
KW - Pain
KW - Torticollis
UR - http://www.scopus.com/inward/record.url?scp=84924007555&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84924007555&partnerID=8YFLogxK
U2 - 10.1016/j.jns.2014.12.030
DO - 10.1016/j.jns.2014.12.030
M3 - Article
C2 - 25595221
AN - SCOPUS:84924007555
VL - 349
SP - 84
EP - 93
JO - Journal of the Neurological Sciences
JF - Journal of the Neurological Sciences
SN - 0022-510X
IS - 1-2
ER -