Category: Dystonia: Clinical Trials and Therapy
Objective: Examine the impact of cervical dystonia (CD) severity on presentation subtype and onabotulinumtoxinA utilization in the completer population from the CD PROBE study.
Background: Additional real-world evidence on the utilization of onabotulinumtoxinA to treat various CD subtypes and disease severities is needed to better guide novice injectors.
Method: Multicenter, prospective, observational registry (NCT00836017); patients with CD were treated with onabotulinumtoxinA according to the standard of care at each clinician’s practice. OnabotulinumtoxinA utilization and safety data were collected at each treatment session. Completers were defined as patients that completed all treatment sessions and had data for all outcome measures.
Results: Of N=1046 patients enrolled in CD PROBE, N=350 were categorized as completers. Completers (N=350) were on average 57.3 years old, 74.9% female, 94.6% White, and 60.6% naïve to botulinum toxin. Of the completers, 54.3% had moderate severity at injection 1, with 32.6% mild and 13.1% severe. Regardless of severity, torticollis was the most common predominant presentation subtype at injection 1 (mild: 44.7%, moderate: 55.8%, severe: 63.0%), followed by laterocollis (mild: 42.1%, moderate: 32.6%, severe: 26.1%). The median onabotulinumtoxinA dose to treat torticollis (injection 1: 160 U, injection 3: 200 U) and laterocollis (injection 1: 170 U, injection 3: 200 U) increased over time. For all severities, the median total dose increased from injection 1 to injection 3 (mild: 138 U to 165 U, moderate: 183 U to 200 U, severe: 200 U to 285 U, respectively). 81 patients (23.1%) reported 139 treatment-related adverse events; there were no treatment-related serious adverse events. No new safety signals were identified.
Conclusion: CD severity impacted presentation subtype frequency and onabotulinumtoxinA utilization in CD PROBE, with higher and tailored dosing observed over time and with increasing disease severity.
To cite this abstract in AMA style:
P. Agarwal, R. Barbano, H. Moore, M. Schwartz, A. Zuzek, A. Patel. Impact of Disease Severity on Presentation Subtype and OnabotulinumtoxinA Utilization in Patients with Cervical Dystonia: Results from the CD PROBE Completer Population [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/impact-of-disease-severity-on-presentation-subtype-and-onabotulinumtoxina-utilization-in-patients-with-cervical-dystonia-results-from-the-cd-probe-completer-population/. Accessed November 22, 2024.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/impact-of-disease-severity-on-presentation-subtype-and-onabotulinumtoxina-utilization-in-patients-with-cervical-dystonia-results-from-the-cd-probe-completer-population/