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SYNCHRONIZE: Real-World Retrospective Safety Analysis of Patients Treated with OnabotulinumtoxinA for More than One Therapeutic Indication

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 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).

Grace Forde,1 Benjamin M. Brucker,2 Kimberly Becker Ifantides,3 Atul T. Patel,4 Angeli Mayadev,5 Theodore Brown,6 Ziyad Ayyoub,7 Kenneth Martinez,8 Ritu Singh,3 Mariana Nelson,3 Simona Battucci,9 Irina Yushmanova,3 Ahunna Ukah,3 and Christopher Rhyne10

  1. NeuroPain Care Center, Lake Success, NY 11042, USA
  2. NYU Langone Health, New York, NY 10017, USA
  3. AbbVie, Irvine, CA 92612, USA
  4. Kansas City Bone & Joint Clinic, Overland Park, KS 66211, USA
  5. Swedish Neuroscience Institute, Seattle, WA 98122, USA
  6. EvergreenHealth Kirkland, Kirkland, WA 98034, USA
  7. Ranchos Los Amigos National Rehabilitation Center, Downey, CA 90242, USA
  8. Neurology & Pain Specialty Center, Aliso Viejo, CA 92656, USA
  9. AbbVie, 00144 Rome, Italy
  10. Diamond Headache Clinic, Chicago, IL 60642, USA
Source: Forde G., Brucker BM., Ifantides KB. et al. SYNCHRONIZE: Real-World Retrospective Safety Analysis of Patients Treated with OnabotulinumtoxinA for More than One Therapeutic Indication. SYNCHRONIZE: Real-World Retrospective Safety Analysis of Patients Treated with OnabotulinumtoxinA for More than One Therapeutic Indication. Toxins. 2024, 16, 420. https://doi.org/10.3390/toxins16100420.