Category: Dystonia: Clinical Trials and Therapy
Objective: This analysis evaluated the sustained effects of onabotulinumtoxinA in patients with CD who were naive or non-naive to botulinum toxin at enrollment in CD PROBE (CD Patient Registry for Observation of BOTOX® Efficacy), a multi-center, prospective, observational study of up to three onabotulinumtoxinA treatments.
Background: OnabotulinumtoxinA is a level-A treatment for cervical dystonia (CD) due to its proven efficacy and safety.
Method: For this analysis, patients were included if they completed all treatment cycles and had accompanying data. Assessments included CD severity, Cervical Dystonia Impact Profile (CDIP-58), Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), treatment interval, and total dose. Adverse events (AEs) were also recorded.
Results: Changes in severity following each onabotulinumtoxinA treatment were generally similar between naive (n=212) and non-naive (n=138) patients. Severity scores were maintained or improved in most patients with mild to moderate symptoms, while 30.0-66.7% with the highest severity scores shifted to a lower severity score across the three treatments. Similarly, sustained improvements were seen in all CDIP-58 subscales and in TWSTRS total scores irrespective of CD severity and toxin status at baseline. The median time interval between injections was similar in naive (93.0–98.0 days) and non-naive patients (96.0–97.0 days); doses tended to be lower in naïve patients. The most common AEs (dysphagia, muscular weakness) were similar.
Conclusion: CD severity was attenuated by repeat onabotulinumtoxinA treatments at consistent intervals regardless of prior botulinum toxin exposure as seen in this preliminary completer analysis. Treatments were well tolerated.
To cite this abstract in AMA style:
P. Agarwal, M. Schwartz, A. Zuzek, A. Patel. Benefits of Treatment with OnabotulinumtoxinA in Naive and Non-naive Patients with Cervical Dystonia are Sustained over Time: Preliminary Completer Analysis from CD PROBE [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/benefits-of-treatment-with-onabotulinumtoxina-in-naive-and-non-naive-patients-with-cervical-dystonia-are-sustained-over-time-preliminary-completer-analysis-from-cd-probe/. Accessed November 22, 2024.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/benefits-of-treatment-with-onabotulinumtoxina-in-naive-and-non-naive-patients-with-cervical-dystonia-are-sustained-over-time-preliminary-completer-analysis-from-cd-probe/