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3468 Real-world retrospective safety analysis in patients treated with onabotulinumtoxinA for multiple therapeutic indications over repeat treatment periods

bmjno · 2025-10-23 · canonical JSON source

11 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background Long-term real-world safety and utilization data are limited for onabotA treatment of concomitant multiple indications.Methods SYNCHRONIZE, a retrospective chart review study conducted at 10 US clinics, evaluated onabotA safety for ≥2 different therapeutic indications within 3-month treatment periods(TPs) in adults. This analysis evaluated safety of onabotA for up to seven repeat TPs within 24months.Results 279 patients were treated for ≥2 therapeutic indications across all treatment indication combination groups analyzed (Period1; mean age, 49.2y; 79% female;56% White) with a gradual decrease to 80 patients during the last TP (Period7). Mean onabotA treatments over the study period was9.3 (range 2–48); the most common indications combination was cervical dystonia and chronic migraine (range 34–44%). Compared to baseline, no significant change in comorbidities and concomitant medications were observed over repeat TPs. In total, 28.7%(80/279) patients reported ≥1 treatment-emergent adverse event (TEAE) after Period1; proportion remained consistent; 29.7%, 29.6%, and 31.3% after Periods 3, 5 and 7, respectively.Common TEAEs across all TPs were UTI (range 0.7–5.7%), neck pain (3.7–9.1%), headache (2.9–6.5%), and migraine (2.5–6.4%). Most patients had a dosage interval of ≤24h (62–98%). Most patients received ≥200-<400U of cumulative 3-months onabotA dose (43–50%) with mean total 3-month dose ranging from 232–287U. There was no apparent trend between TEAE incidence and dosage intervals or cumulative 3-month dose. No patients were determined to have lack of effect.Conclusion OnabotA demonstrated consistent safety with no new signals observed in patients treated concomitantly for ≥2 therapeutic indications over repeat treatments up to 24months.