Characteristics and Treatment Response to OnabotulinumtoxinA of Patients From CD-PROBE With Anterocollis and Retrocollis
Khashayar Dashtipour1, Joseph Jankovic2, David Charles3, Shyamal Mehta4, Marc Schwartz5, Marjan Sadeghi6
1Loma Linda University, 2Baylor College of Medicine, 3Vanderbilt University Medical Center, 4Mayo Clinic, Arizona, 5MS Biostatistics, LLC, 6Abbvie/Allergan
Objective:
To describes baseline characteristics and treatment response of these cervical dystonia (CD) subtypes.
Background:
CD-PROBE included patients with anterocollis (AC) and retrocollis (RC) treated with onabotulinumtoxinA (onabotA).
Design/Methods:
CD PROBE was an observational, prospective study designed to identify real-world outcomes in patients with CD after onabotA treatment; patients from 82 US sites with CD diagnosis who were candidates for onabotA therapy, new to treatment, or not previously treated in a clinical trial in ≥16 weeks, and completed 3 onabotA treatments. Treatment benefit was measured using the Patient’s Global Impression of Change (PGI-C), Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), Cervical Dystonia Impact Profile (CDIP-58), Clinician’s Global Impression of Change (CGI-C), and physician assessments of CD severity.
Results:
Patients with AC (n=59) and RC (n=55) were older and more disabled, with a shorter time to diagnosis and treatment, than patients with laterocollis (LC) or torticollis (TC). From PGI-C responses, 58.4% of RC vs 47.8% of AC patients reported being much/very much improved by onabotA post-injection 3 (final visit). CGI-C responses similarly improved over this timeframe; 82.6% of RC and 60.9% of AC patients reporting much/very much improved. The mean total TWSTRS score decreased for AC and RC patients from injection 1 (46 [AC]; 40 [RC]) to final visit (36 [AC]; 32 [RC]); CDIP-58 scores also decreased over time. The proportion of patients with physician-assessed severe CD decreased from injection 1 (28.8% [AC]; 21.8% [RC]) to final visit (21.7% [AC]; 4.3% [RC]); most patients shifted to lower symptom severity. OnabotA dose generally increased per visit, with AC patients having lowest doses (153.5–195.4U) and RC patients the highest (184.0–213.4U). Adverse event of dysphagia reported in 4 AC and 7 RC patients. No new safety signals were identified.
Conclusions:
CD PROBE data indicates real-world treatment with onabotA relieves CD symptoms in patients with anterocollis and retrocollis.