SYNCHRONIZE: Real-World Retrospective Safety Analysis of Patients Treated with OnabotulinumtoxinA for More than One Therapeutic Indication.
Publication Title
Toxins (Basel)
Document Type
Article
Publication Date
9-29-2024
Keywords
Humans; Botulinum Toxins, Type A; Retrospective Studies; Male; Female; Middle Aged; Adult; Aged; Migraine Disorders; Torticollis; Neuromuscular Agents; Treatment Outcome; cervical dystonia; chronic migraine; multiple therapeutic indications; onabotulinumtoxinA; overactive bladder; safety; spasticity; treatment-emergent adverse event.; washington; swedish; swedish neurosci
Abstract
OnabotulinumtoxinA (onabotA) is approved in the US for 12 therapeutic indications. Real-world data on onabotA multi-indication use are limited, often leading to delayed or reduced treatment. This study provides real-world evidence on the safety of onabotA when treating multiple indications concomitantly. SYNCHRONIZE was a multicenter, retrospective, chart-review study evaluating onabotA's safety for adults treated for ≥2 therapeutic indications within a 3-month period. The primary outcome was treatment-emergent adverse events (TEAEs) within 6 months post-treatment. A total of 279 patients were included. The most common concomitant indications treated were cervical dystonia and chronic migraine (43.4%). The average 3-month cumulative dose for multiple indications was 282.2 U. The treatment interval for multiple indications was ≤24 h for most patients (62.4%). Overall, 28.7% of patients reported ≥1 TEAE with no apparent trends in TEAEs and dose interval or cumulative dose. Reported TEAEs included UTI (5.7%), neck pain (5.0%), and headache (4.3%). No patient had a lack of effect according to clinical objective measurements. SYNCHRONIZE described the real-world safety of onabotA for patients treated concomitantly for ≥2 indications within a 3-month period. TEAEs were generally consistent with the known safety profiles of individual indications. No new safety signals were identified).
Area of Special Interest
Neurosciences (Brain & Spine)
Specialty/Research Institute
Neurosciences
Specialty/Research Institute
Pharmacy
DOI
10.3390/toxins16100420
