Primary results from the cervical dystonia patient registry for observation of onabotulinumtoxina efficacy (CD PROBE).

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 ± 87.1U, 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.

• Authors: Joseph Jankovic, Charles H Adler, David Charles, Cynthia Comella, Mark Stacy, Marc Schwartz, Aubrey Manack Adams, Mitchell F Brin
• Journal: Journal of the neurological sciences (J Neurol Sci) Vol. 349 Issue 1-2 Pg. 84-93 (Feb 15 2015) ISSN: 1878-5883 [Electronic] Netherlands
• PMID: 25595221 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier B.V. All rights reserved.

Chemical References

• Acetylcholine Release Inhibitors
• Botulinum Toxins, Type A

Topics

• Acetylcholine Release Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Adult
• Aged
• Botulinum Toxins, Type A (administration & dosage, adverse effects, therapeutic use)
• Deglutition Disorders (chemically induced)
• Dose-Response Relationship, Drug
• Female
• Humans
• Male
• Middle Aged
• Muscle Weakness (chemically induced)
• Observational Studies as Topic
• Prospective Studies
• Registries
• Torticollis (drug therapy, physiopathology)
• Treatment Outcome