OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE.

Autor:	Agarwal P; Evergreen Medical Center, Kirkland, WA, United States.; University of Washington, Seattle, WA, United States., Barbano R; University of Rochester, Rochester, NY, United States., Moore H; University of Miami-Miller School of Medicine, Miami, FL, United States., Schwartz M; MS Biostatistics LLC, Clermont, FL, United States., Zuzek A; AbbVie, Irvine, CA, United States., Sadeghi M; AbbVie, Irvine, CA, United States., Patel A; Kansas City Bone & Joint Clinic, Overland Park, KS, United States.; University of Missouri, Kansas City, MO, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in neurology [Front Neurol] 2022 Jun 30; Vol. 13, pp. 914486. Date of Electronic Publication: 2022 Jun 30 (Print Publication: 2022).
DOI:	10.3389/fneur.2022.914486
Abstrakt:	Introduction: The Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE) study (ClinicalTrials.gov identifier: NCT00836017), a multicenter, prospective, observational registry, was designed to identify real-world practices and outcomes for patients with cervical dystonia (CD) treated with onabotulinumtoxinA (onabotA). This secondary analysis from CD PROBE aims to determine the impact of presentation subtype on onabotA utilization and CD severity. Materials and Methods: The study cohort includes those who completed all 3 treatments, 4 office visits, and had data recorded for all assessments. Patient outcomes were assessed with the Cervical Dystonia Impact Profile (CDIP-58), Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), and determination of CD severity. Treatment interval, dose, and adverse events (AEs) were also recorded. Data were stratified according to prior exposure to botulinum toxins (BoNTs) and analyzed with descriptive statistics. Results: Torticollis was the most common presentation subtype in the study cohort ( N = 350); the proportion of patients with torticollis was highest in those with severe disease. At each treatment, between 40.7 and 65.2% of those categorized as severe shifted to moderate or mild severity after treatment. Sustained improvements in CDIP-58 and TWSTRS were observed regardless of prior exposure to BoNTs. Dosing of onabotA generally increased from injection 1 to injection 3 and tended to be lower for patients naïve to BoNT. Median time interval between injections for the study cohort was 94.0 to 97.5 days. The most common AEs (dysphagia, muscular weakness) and injection intervals were similar between naïve vs. non-naïve patients; there were no serious treatment-related AEs. Conclusions: This secondary cohort analysis from CD PROBE demonstrates that three repeat treatments with onabotA at intervals consistent with labeling attenuated disease severity and neck pain, resulting in sustained improvements in physician- and patient-reported outcomes. No new safety signals were identified. Competing Interests: PA has served as a speaker/consultant for AbbVie, Acadia, Accorda, Adamas Pharmaceuticals, Amneal, Kyowa Kirin, Sunovion, and US WorldMeds. RB serves as an associate editor for Neurology: Clinical Practice; performs botulinum toxin injections at the University of Rochester (40% effort); serves/has served on scientific advisory boards for Allergan, Ipsen, Merz, and Revance; receives research support from Fox Foundation, NIH (via NINDS, ORDR: Dystonia Coalition Projects, Site PI), Revance, and Vaccinex; consultant for Oscine Corporation; consultant for AbbVie and independent rater for AbbVie's ELATE trial; receives fees as section editor and holds stock options in VisualDx; and has served as an expert witness in legal proceedings including malpractice, not involving commercial entities. HM has served as consultant for AbbVie, Acadia, Adamas Pharmaceuticals Inc., Amneal Pharmaceuticals LLC, Lunbeck LLC, Merz, Neurocrine Biosciences, Sunovion, TEVA Pharmaceuticals, UCB, and US World Meds. MSc is the founder of MS Biostatistics, LLC, and was formerly an employee of MedNet Solutions Inc., which was contracted by Allergan to provide biostatistical services for the study. AZ and MSa are employees of AbbVie and may hold AbbVie stock. AP has served as a consultant and speaker for Allergan (an AbbVie company), Ipsen, and as a consultant for Revance. He has received research funding for clinical trials from Allergan, Ipsen, and Revance. Medical writing was provided by A. Preininger, an employee of AbbVie. Editorial assistance was provided by A. Hadsell, an employee of AbbVie. The authors declare that this study received funding from AbbVie. The funder had the following involvement in the study: trial design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. (Copyright © 2022 Agarwal, Barbano, Moore, Schwartz, Zuzek, Sadeghi and Patel.)
Databáze:	MEDLINE
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