Abstract
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.