SYNCHRONIZE: real-world retrospective safety analysis in chronic migraine patients treated with OnabotulinumtoxinA for ≥1 indication
<h3>Objective</h3> Assess real-world safety of onabotulinumtoxinA (onabotA) concomitant administration for the prevention of chronic migraine (CM) and ≥1 other therapeutic indications (TIs). <h3>Methods</h3> Phase 4, retrospective chart review conducted at 10 US sites, evaluated the safety of onabotA in adults treated for multiple TIs within a 3-month period. Data collected for up to 24 months. <h3>Results</h3> Of 279 patients, 183 (66%) received onabotA for prevention of CM and ≥1 concomitant TI. Most (n=114; 62%) were treated for multiple TIs within 24 hours. 60 patients (33%) traveled ≥20 miles for onabotA treatment. Treatment-emergent adverse events (TEAEs) occurred in 23% (42/183) of patients within 6 months and were consistent up to 24 months (31%; 18/58). There was no apparent trend between AEs and dosing intervals or cumulative 3-month dose. No patients were determined to have a lack of effect based on clinical objective measurement. <h3>Conclusions</h3> In this real-world study, onabotA demonstrated consistent safety, with no new signals in adults treated concomitantly for the prevention of CM and other TIs within a 3-month period. Most patients received injections within 24 hours. Some patients traveled a long distance to receive onabotA treatment, highlighting the potential burden of treating multiple TIs on separate days.
Authors
- B. Giritharan Andrew
- Ingrid Becker (ORCID: https://orcid.org/0000-0001-5829-3553)
- Crocker Alicia
- Forde Grace
- Reynaldo Christopher
- Singh Ritu
- Sommer Katherine
- Battucci Simona
Institutions
- AbbVie (United States) (US)
- Pain and Headache Center (US)
- Diamond Headache Clinic (US)
- Neurology Center of Southern California (US)
- AbbVie (United Kingdom) (GB)
Publication Details
- Published
- 2024-11-01
- DOI
- https://doi.org/10.1136/jnnp-2024-abn.120
- Primary Topic
- Migraine and Headache Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00