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Introduction <p>Patients receiving onabotulinumtoxinA treatment for chronic migraine (CM) may have coexisting diseases warranting multi-indication use of onabotulinumtoxinA. However, data on safety and treatment patterns for concomitant treatment of CM and other diseases are limited.</p> Methods <p>SYNCHRONIZE was a phase&#xa0;4, multicenter, retrospective study that explored the safety of onabotulinumtoxinA treatment for ≥ 2 therapeutic (non-aesthetic) indications within 3&#xa0;months. The observation period of interest was approximately 6&#xa0;months before and 24&#xa0;months after receiving treatment for the second indication. The primary outcome was treatment-emergent adverse events (TEAEs) occurring within 6&#xa0;months. Results are reported descriptively and stratified by treatment indications. This analysis focuses on patients treated for CM and ≥ 1 other onabotulinumtoxinA indication.</p> Results <p>A total of 183 patients had CM and ≥ 1 other onabotulinumtoxinA indication (CM + cervical dystonia [CD], <i>n</i> = 121; CM + oromandibular dystonia [OD] ± blepharospasm [BS], <i>n</i> = 17; CM + BS or hemifacial spasm [HS], <i>n</i> = 13; CM + CD + other movement disorders [MD], <i>n</i> = 11; CM + spasticity [SP] or focal dystonia [FD], <i>n</i> = 10; CM + hyperhidrosis [HH] ± other MD, <i>n</i> = 5; CM + overactive bladder [OAB] or neurogenic detrusor overactivity [NDO], <i>n</i> = 4; CM + other MD, <i>n</i> = 2). The 3-month mean cumulative onabotulinumtoxinA dose ranged from 163.4&#xa0;U (CM + OD ± BS) to 396.2&#xa0;U (CM + SP or FD), and most patients received treatment for their first and subsequent indications within 24&#xa0;h. The proportion of patients with ≥ 1 TEAE in the 6&#xa0;months post-index was 23.5% overall, with the most common being neck pain (6.6%), headache (4.9%), migraine (4.9%), and brow ptosis (2.2%). There were no TEAEs consistent with distant spread of toxin and no discontinuations due to adverse events.</p> Conclusion <p>TEAEs associated with onabotulinumtoxinA treatment in adults with CM and ≥ 1 coexisting disease within 3&#xa0;months were generally consistent with the known safety profiles for the individual onabotulinumtoxinA indications. There were no new safety signals observed for up to 6&#xa0;months after multi-indication treatment.</p>

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Real-World Retrospective Safety Analysis of OnabotulinumtoxinA for the Treatment of Patients with Chronic Migraine and Concomitant Therapeutic Indications

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  • 发表日期：

    2026年2月12日

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  • Andrew M. Blumenfeld,
  • Christopher Rhyne,
  • Kenneth Martinez,
  • Atul Patel,
  • Kim Becker Ifantides,
  • Ritu Singh,
  • Irina Yushmanova,
  • Simona Battucci,
  • Marc Schwartz,
  • Grace Forde

摘要

Introduction

Patients receiving onabotulinumtoxinA treatment for chronic migraine (CM) may have coexisting diseases warranting multi-indication use of onabotulinumtoxinA. However, data on safety and treatment patterns for concomitant treatment of CM and other diseases are limited.

Methods

SYNCHRONIZE was a phase 4, multicenter, retrospective study that explored the safety of onabotulinumtoxinA treatment for ≥ 2 therapeutic (non-aesthetic) indications within 3 months. The observation period of interest was approximately 6 months before and 24 months after receiving treatment for the second indication. The primary outcome was treatment-emergent adverse events (TEAEs) occurring within 6 months. Results are reported descriptively and stratified by treatment indications. This analysis focuses on patients treated for CM and ≥ 1 other onabotulinumtoxinA indication.

Results

A total of 183 patients had CM and ≥ 1 other onabotulinumtoxinA indication (CM + cervical dystonia [CD], n = 121; CM + oromandibular dystonia [OD] ± blepharospasm [BS], n = 17; CM + BS or hemifacial spasm [HS], n = 13; CM + CD + other movement disorders [MD], n = 11; CM + spasticity [SP] or focal dystonia [FD], n = 10; CM + hyperhidrosis [HH] ± other MD, n = 5; CM + overactive bladder [OAB] or neurogenic detrusor overactivity [NDO], n = 4; CM + other MD, n = 2). The 3-month mean cumulative onabotulinumtoxinA dose ranged from 163.4 U (CM + OD ± BS) to 396.2 U (CM + SP or FD), and most patients received treatment for their first and subsequent indications within 24 h. The proportion of patients with ≥ 1 TEAE in the 6 months post-index was 23.5% overall, with the most common being neck pain (6.6%), headache (4.9%), migraine (4.9%), and brow ptosis (2.2%). There were no TEAEs consistent with distant spread of toxin and no discontinuations due to adverse events.

Conclusion

TEAEs associated with onabotulinumtoxinA treatment in adults with CM and ≥ 1 coexisting disease within 3 months were generally consistent with the known safety profiles for the individual onabotulinumtoxinA indications. There were no new safety signals observed for up to 6 months after multi-indication treatment.