(Research Hub Theater) SYNCHRONIZE: Real-world Retrospective Safety Analysis in Patients Treated with OnabotulinumtoxinA for More Than One Therapeutic Indication

Background and/or Objectives: Therapeutic onabotulinumtoxinA is approved in the US for 12 indications, some of which are comorbid in specific patient populations. Safety data for treating comorbid indications concomitantly are limited. Report real-world safety of onabotulinumtoxinA used concomitantly for multiple therapeutic indications.

Design: SYNCHRONIZE was a phase 4, retrospective chart review study. Dosage interval was the difference between the dates of first and last onabotulinumtoxinA treatments for multiple indications.

Setting : 10 US clinical sites

Participants : Adults treated with onabotulinumtoxinA for >1 therapeutic indication within 3-month periods for up to 24 months

Interventions: OnabotulinumtoxinA

Main Outcome Measures: Proportion of patients reporting ≥1 treatment-emergent adverse event (TEAE) within 6 months post-index (date the patient met study inclusion criteria).

Results: 279 included patients (mean age, 49.2 years; 78% female; 56% White) received a mean (SD) of 9.3 (6.6) onabotulinumtoxinA treatments (range 2-48) over 24 months. The most common indication combination group was cervical dystonia (CD)/chronic migraine (CM) (43%). Overall mean (SD) cumulative 3-month onabotulinumtoxinA dose administered to treat multiple therapeutic indications was 281.34U (186.72U). Across all combination groups, 28.7% of patients reported ≥1 TEAE within 6 months post-index; this proportion remained broadly consistent over 24 months. The most common TEAEs were urinary tract infection (6%), mostly after treatment for urological indications; neck pain (5%), mostly after treatment of CM and/or CD; and headache (4%), reported mostly by patients treated for CM. Dosage interval for multiple indications was ≤24 hours for most patients (62%). TEAE incidence varied across dosing intervals (from 30.5% [≤24 hours] to 35.3% [71-84 days]), with no apparent relationship to dosing interval or 3-month cumulative dose. No patients had lack of effect by clinical objective measurement. Adverse events were consistent with those previously reported for individual indications.

Conclusions: In this real-world study, no new safety signals were recorded in adult patients treated for ≥2 therapeutic indications with onabotulinumtoxinA concomitantly within a 3-month period.