ArticlePain and therapy2026
Real-World Retrospective Safety Analysis of OnabotulinumtoxinA for the Treatment of Patients with Chronic Migraine and Concomitant Therapeutic Indications.
Article in Pain and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionPatients 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.
methodsSYNCHRONIZE 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.
resultsA 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.
conclusionTEAEs 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.
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