SYNCHRONIZE: Real-World Retrospective Review of Safety in Patients Treated With OnabotulinumtoxinA for More Than 1 Therapeutic Indication: An Epidemiologic Perspective
Grace Forde1, Ken Martinez2, Angeli Mayadev3, Benjamin Brucker4, Atul Patel5, Kimberly Becker Ifantides6, Ritu Singh6, Aleksej Zuzek6, Ahunna Ukah6, Christopher Rhyne7
1Forde Headache and Pain Center, Lake Success NY, 2Neurology & Pain Specialty Center, Aliso Viejo, CA, USA, 3Swedish Neuroscience Institute, Seattle WA, USA, 4NYU Langone Health, New York, NY, USA, 5Kansas City Bone & Joint Clinic, Overland Park, KS, USA, 6AbbVie, Irvine, CA, USA, 7Diamond Headache Clinic, Chicago, IL, USA
Objective:
Describe demographics, baseline characteristics, and therapeutic indications of patients treated with onabotulinumtoxinA (onabotA) for simultaneous multiple therapeutic indications in the SYNCHRONIZE real-world study
Background:

OnabotA is approved by the US Food and Drug Administration (FDA) for treatment of 12 therapeutic and 3 cosmetic indications. However, data are limited on the use of onabotA when treating multiple indications. This often leads to delayed or reduced treatment which may negatively impact patient care. SYNCHRONIZE aimed to provide real-world evidence on the safety of onabotA when treating multiple therapeutic indications within a 3-month period.

Design/Methods:

This retrospective, chart review study analyzed data from medical records of adult patients from 10 US clinical sites who were treated with onabotA for >1 therapeutic indication within a 3-month period. Patients were followed for up to 24 months.

Results:

Of 279 patients enrolled (mean [SD] age 49.2 [14.4] years, 78% female, 56% White), most (n=220, 79%) were treated with onabotA for multiple indications by the same provider. The most common comorbidities at baseline (>10%) were migraine (24%), significant pain condition (14%), and anxiety (11%). Most patients received onabotA treatments for 2 indications; the most common treatment indication combination group was cervical dystonia and chronic migraine (n=121, 43%), followed by overactive bladder and spasticity (n=28, 10%). Sixteen patients received onabotA for 3 or more indications within a 3-month period; the most common treatment indication combination for these patients was cervical dystonia, chronic migraine, and oromandibular dystonia (n=4; 1.4%).

Conclusions:

OnabotulinumtoxinA is FDA-approved for multiple indications. SYNCHRONIZE evaluated real-world utilization and safety when patients were concurrently treated for ≥2 indications within a 3-month period. Baseline data from SYNCHRONIZE indicated that most patients were treated for 2 indications and the most common overlapping indications were cervical dystonia and chronic migraine. OnabotulinumtoxinA safety and utilization data continues to be evaluated.

10.1212/WNL.0000000000201812