Real-World Adherence to OnabotulinumtoxinA Treatment for Spasticity: Insights From the ASPIRE Study

Esquenazi, Alberto; Francisco, Gerard E.; Feng, Wuwei; Baricich, Alessio; Gallien, P.; Fanning, Kristina M.; Zuzek, Aleksej; Bandari, Daniel S.; Wittenberg, George F.

doi:10.1016/j.apmr.2021.06.008

Cited by 3 publications

(1 citation statement)

References 39 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[15][16][17][18][19][20][21][22][23] The real-world, multicenter, prospective, Adult SPasticity International REgistry (ASPIRE) study (NCT01930786) examined the patterns of real-world onabotulinumtoxinA utilization in the clinical setting and assessed the effectiveness of onabotulinumtoxinA treatment for spasticity. 15,16,24,25 Findings of ASPIRE demonstrated that among the 484 patients who received ≥1 treatment of onabotulinumtoxinA for UL spasticity, stroke was the most frequently reported underlying etiology (74.0% of patients) and clenched fist was the most commonly treated UL clinical presentation (79.1% of patients). 15 Across all presentations, the dose of onabotulinumtoxinA treatment ranged from 5 to 600 U, and treatment use varied by presentation.…”

Section: What Is Newmentioning

confidence: 99%

Safety and real-world dosing of onabotulinumtoxinA for the treatment of adult spasticity: post hoc analysis of the Adult Spasticity International Registry study

Bavikatte,

Esquenazi,

Dimyan

et al. 2024

Am J Phys Med Rehabil

Self Cite

View full text Add to dashboard Cite

Objective To evaluate the safety of onabotulinumtoxinA treatment for spasticity across dose ranges in real-world practice. Design Adult Spasticity International Registry (ASPIRE) was a multicenter, prospective, observational study (NCT01930786) of onabotulinumtoxinA treatment for adult spasticity over 2 years. Adverse events (AEs), serious AEs (SAEs), treatment-related AEs (TRAEs), and TRSAEs were sorted into 5 categories (≤200 U, 201-400 U, 401-600 U, 601-800 U, ≥801 U) based on cumulative dose per session. Results In 3103 treatment sessions (T), 730 patients received ≥1 dose of onabotulinumtoxinA. Dose categories included: ≤200 U (n = 312; t = 811), 201-400 U (n = 446, t = 1366), 401-600 U (n = 244, t = 716), 601-800 U (n = 69, t = 149), ≥801 U (n = 29, t = 61). Of these patients, 261 reported 827 AEs, 94 reported 195 SAEs, 20 reported 23 TRAEs, and 2 patients treated with 201-400 U onabotulinumtoxinA reported 3 TRSAEs. TRAEs reported: ≤200 U (8 TRAEs/811, 0.9%); 201-400 U (7/1366, 0.5%); 401-600 U (6/716, 0.8%); 601-800 U (1/149, 0.7%); ≥801 U (1/61, 1.6%). Conclusions In this post hoc analysis, most treatment sessions were performed with 201-400 U onabotulinumtoxinA. Patients treated with 201-400 U onabotulinumtoxinA had an AE profile consistent with onabotulinumtoxinA package inserts globally (eg, United States, European Union, United Kingdom, Canada). No new safety signals were identified.

show abstract

Section: What Is Newmentioning

confidence: 99%

Safety and real-world dosing of onabotulinumtoxinA for the treatment of adult spasticity: post hoc analysis of the Adult Spasticity International Registry study

Bavikatte,

Esquenazi,

Dimyan

et al. 2024

Am J Phys Med Rehabil

Self Cite

View full text Add to dashboard Cite

show abstract

Pain, disability, and quality of life in participants after concurrent onabotulinumtoxinA treatment of upper and lower limb spasticity: Observational results from the ASPIRE study

Bavikatte,

Francisco,

Jost

et al. 2024

PM&R

View full text Add to dashboard Cite

IntroductionUpper and lower limb spasticity is commonly associated with central nervous system disorders including stroke, traumatic brain injury, multiple sclerosis, cerebral palsy, and spinal cord injury, but little is known about the concurrent treatment of upper and lower limb spasticity with botulinum toxins.ObjectiveTo evaluate onabotulinumtoxinA (onabotA) utilization and to determine if concurrent onabotA treatment of the upper and lower limbs has supported improvements in participants with spasticity.DesignSub‐analysis of a 2‐year, international, prospective, observational registry (ASPIRE, NCT01930786).SettingInternational clinic sites (54).ParticipantsAdult spasticity participants across etiologies, who received ≥1 concurrent onabotA treatment of the upper and lower limbs during the study.InterventionParticipants were treated with onabotA at the clinician's discretion.OutcomesBaseline characteristics and outcomes of disability (Disability Assessment Scale [DAS]), pain (Numeric Pain Rating Scale [NPRS]), participant satisfaction, physician satisfaction, and quality of life (QoL; Spasticity Impact Assessment [SIA]) were evaluated. Adverse events were monitored throughout the study.ResultsOf 744 participants enrolled, 730 received ≥1 dose of onabotA; 275 participants received treatment with onabotA in both upper and lower limbs during ≥1 session; 39.3% of participants were naïve to onabotA for spasticity. The mean (SD) total dose per treatment session ranged from 421.2 (195.3) to 499.6 (188.6) U. The most common baseline upper limb presentation was clenched fist (n = 194, 70.5%); lower limb was equinovarus foot (n = 219, 66.9%). High physician and participant satisfaction and improvements in pain, disability and QoL were reported after most treatments. Nine participants (3.3%) reported nine treatment‐related adverse events; two participants (0.7%) reported three serious treatment‐related severe adverse events. No new safety signals were identified.ConclusionMore than a third of enrolled participants received at least one concurrent onabotA treatment of the upper and lower limbs, with reduced pain, disability, and improved QoL after treatment, consistent with the established safety profile of onabotA for the treatment of spasticity.

show abstract

A look at the future—new BoNTs and delivery systems in development: What it could mean in the clinic

Kaji

2023

Toxicon

View full text Add to dashboard Cite

Real-World Adherence to OnabotulinumtoxinA Treatment for Spasticity: Insights From the ASPIRE Study

Cited by 3 publications

References 39 publications

Safety and real-world dosing of onabotulinumtoxinA for the treatment of adult spasticity: post hoc analysis of the Adult Spasticity International Registry study

Safety and real-world dosing of onabotulinumtoxinA for the treatment of adult spasticity: post hoc analysis of the Adult Spasticity International Registry study

Pain, disability, and quality of life in participants after concurrent onabotulinumtoxinA treatment of upper and lower limb spasticity: Observational results from the ASPIRE study

A look at the future—new BoNTs and delivery systems in development: What it could mean in the clinic

Contact Info

Product

Resources

About