Two-year real-world retrospective safety evaluation with onabotulinumtoxinA across multiple therapeutic indications: Findings from the SYNCHRONIZE study.

OnabotulinumtoxinA (onabotA) is approved for the treatment of various therapeutic indications, which require retreatment. In clinical practice, many patients receive onabotA for multiple therapeutic indications concomitantly over extended time periods; however, there is limited long-term utilization and safety data for treating comorbid indications. SYNCHRONIZE, a 2-year, multicenter, retrospective observational chart review study in 10 US clinics, describes onabotA real-world utilization and safety in adults treated for ≥2 therapeutic indications within repeating 3-month periods for up to 7 treatments. This analysis assessed the long-term onabotA safety profile for multiple therapeutic indications by analyzing the incidence of treatment-emergent adverse events (TEAEs). Of 279 patients treated for ≥2 different therapeutic indications across all treatment combination groups in Period1, there was a gradual decrease to 80 patients at the last treatment period. The overall mean onabotA treatments over the study period was 9.3 (range: 2-48). Across treatment periods, most patients had a treatment interval between different indications of ≤24 h (range: 62-98 %) and received ≥200-<400U of cumulative 3-month dosages for multiple indications (range: 43 %-50 %) with a mean 3-month dose from 231.8 to 287.0 U. In total, 28.7 % of patients reported ≥1 TEAE after Period1; this proportion remained broadly constant across treatments (range: 28.3-31.8 %). Overall, the most common TEAEs across treatments were UTIs (range: 0.7-5.7 %), neck pain (range: 3.7-9.1 %), headache (range: 2.9-6.5 %), and migraine (range: 2.5-6.4 %). There was no apparent trend between TEAE incidence and treatment intervals nor cumulative 3-month dose categories for multiple indications. No patients were determined to have lack of effect based on clinical objective measurement. OnabotA showed a safety profile with no new signals in patients treated concomitantly for ≥2 therapeutic indications over repeat treatments up to 2 years. TEAEs across treatment periods were commonly related to the site of injection and were consistent with those previously reported for individual indications.