Author(s): Francisco G.E.; Bandari D.S.; Bavikatte G.; Jost W.H.; Zuzek A.; McCusker E.; Patel A.; Largent J.; Esquenazi A.
Source: Annals of Physical and Rehabilitation Medicine; 2018
Publication Date: 2018
Publication Type(s): Article In Press
Abstract:Introduction/Background: Etiology-specific differences in onabotulinumtoxin A utilization to treat spasticity are largely unknown. Real-world clinical practice data from the ASPIRE study may help optimize onabotulinumtoxin A treatment for spasticity. Our objective is to evaluate real-world utilization of onabotulinumtoxin A for spasticity caused by various etiologies. Material and method: 1-year interim analysis; international, multicenter, prospective, observational study (NCT01930786) examining adult patients with spasticity across etiologies. Patients were treated with onabotulinumtoxin A at the physician’s discretion; utilization patterns were recorded at each visit. Results: A total of 731 patients received >= 1 onabotulinumtoxinA treatment; 37% of patients were naive to botulinum toxins for spasticity. The most common etiology was stroke (n = 411/731, 56%), followed by multiple sclerosis (MS; n = 119/731, 16%), cerebral palsy (CP; n = 77/731, 11%), traumatic brain injury (TBI; n = 45/731, 6%), spinal cord injury (SCI; n = 42/731, 6%), and other (n = 72/731). Across etiologies (n = 731), total onabotulinumtoxin A doses per treatment session ranged from 45-1038 U. The most frequently treated lower limb presentations, with mean doses injected per presentation, varied by etiology. Stroke: equinovarus foot (223 U [SD = 131]), flexed toe (64 U [SD = 51]), and flexed knee (143 U [SD = 86]); MS: equinovarus foot (206 U [SD = 124]), stiff extended knee (155 U [SD = 134]), and adducted thigh (173 U [SD = 112]); CP: equinovarus foot (162 U [SD = 116]), flexed knee (150 U [SD = 89]), and adducted thigh (163 U [SD = 94]); TBI: equinovarus foot (223 U [SD = 109]), flexed toe (89 U [SD = 61]), and flexed knee (154 U [SD = 60]); and SCI: equinovarus foot (277 U [SD = 168]), adducted thigh (140U [SD = 66]), and flexed knee (165 U [SD = 84]). In the overall population (n = 731), adverse events (AEs) were reported by 28.9% of patients, with 2.3% of events considered treatment-related. Serious AEs were reported by 10.3% of patients, with 0.3% of events considered treatment-related. No new safety signals were identified. Conclusion: Real-world 1-year interim data from ASPIRE captured etiology-specific utilization of onabotulinumtoxin A for spasticity in clinical practice, while further demonstrating safety across etiologies.
Copyright © 2018