1334 - SYNCHRONIZE: Real-world retrospective safety analysis in patients treated with onabotulinumtoxinA for more than one therapeutic indication

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. This study reportsreal-world safety of onabotulinumtoxinA used concomitantly for multiple therapeutic indications.

Design: In SYNCHRONIZE, a phase 4, retrospective chart review study of 10 US clinical sites, medical records of adults treated with onabotulinumtoxinA for >1 therapeutic indication within 3-month periods for up to 24 months were evaluated. Dosage interval was defined as the difference between the dates of first and last onabotulinumtoxinA treatments for multiple indications. 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).

Results: Across all combination groups, 28.7% of patients reported ≥1 treatment-emergent adverse event (TEAE) within 6 months post-index (date the patient met study inclusion criteria); this proportion of patients remained broadly consistent over 24 months. The most common TEAEs overall 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.