Abstract
Introduction This SYNCHRONIZE subanalysis evaluated real-world onabotA safety profile for patients treated concomitantly for spasticity and other therapeutic indications.
Methods SYNCHRONIZE, a multicenter, retrospective, chart review study conducted at 10 US sites, evaluates onabotA safety for treatment of multiple therapeutic indications within 3-months. Primary outcome was treatment-emergent adverse events(TEAEs) ≤6 months post-index-date; follow-up ≤24months.
Results Of 279 patients,18.6%(n=52)(mean age 47.4;65.4%female;69.2%White) were treated concomitantly for spasticity and other therapeutic indications. The subanalysis included 5 treatment combinations; spasticity combined with:NDO (n=28;53.8%), CD(n=11), CM(n=5), ≥3 indications treated(n=4), other dual treatment combinations(n=4). Patients received mean(SD) of 8.1(7.6) onabotA treatments(range 2–48) over 24months. 51.9%(n=27/52) of patients reported ≥1 TEAE within 6months post-index-date, with the majority(n=17) in the spasticity+NDO group. Most frequent TEAE was UTI (overall:23.1%[n=12/52];spasticity+NDO:39.3%[n=11/28]) associated with urological treatment. Anxiety, dysphagia, headache, extremity pain, allergic rhinitis occurred in 3.8%(n=2/52) patients. Most common cumulative 3-month dosage was ≥400to<600U(34.6%;n=18/52); 44.4%(n=8/18) TEAE incidence. No apparent correlation between TEAEs among patients receiving ≥200to<400U and ≥600to<800U. TEAEs were highest(72.7%; n=8/11) >24hours to 13days; most common TEAEs reported in this interval were UTIs(37.5%;n=3/8). Generally, TEAEs were injection site related. Treatment discontinuation in 3 patients;2 in spasticity+NDO(1 due to AE, 1 due to bladder augmentation surgery; patient continued spasticity treatment); 1 in spasticity+CM group (physician determined treatment no longer necessary). No patients had lack of effect by clinical objective measurement.
Conclusion Overall safety results were consistent with known onabotA safety profile for individual therapeutic indications. Most common TEAE was UTI with the highest proportion the spasticity+NDO group. No new safety signals identified.
