Dataset Information

Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study.

ABSTRACT: Introduction: OnabotulinumtoxinA treatment for spasticity is dependent on numerous factors and varies according to selected treatment goals.

Objective: To examine real-world onabotulinumtoxinA treatment utilization and effectiveness in patients with upper limb spasticity over 2?years from the Adult Spasticity International Registry (ASPIRE) study.

Design: Multicenter, prospective, observational registry (NCT01930786).

Setting: Fifty-four international clinical sites in North America, Europe, and Asia.

Patients: Adults (naïve or non-naïve to botulinum toxins for spasticity) with upper limb focal spasticity related to upper motor neuron syndrome across multiple etiologies.

Interventions: OnabotulinumtoxinA administered at clinician's discretion.

Main outcome measures: OnabotulinumtoxinA utilization, clinician and patient satisfaction.

Results: Four hundred eighty-four patients received ?1 treatment of onabotulinumtoxinA for upper limb spasticity. Patients were on average 55.1?years old, 50.8% male, predominantly Caucasian (72.3%), and 38.6% were naïve to botulinum toxins. Stroke was the most frequently reported underlying etiology (74.0%). Most patients (81.2%) had moderate to severe spasticity at baseline. The most commonly treated upper limb clinical presentation was clenched fist (79.1% of patients). Across all presentations, onabotulinumtoxinA doses ranged between 5-600U. Electromyography (EMG) was most often utilized to localize muscles (?57.0% of treatment sessions). Clinicians (92.9% of treatment sessions) and patients (85.7%) reported being extremely satisfied/satisfied that treatment helped manage spasticity, and clinicians (98.6%) and patients (92.2%) would definitely/probably continue onabotulinumtoxinA treatment. One hundred seventy-nine patients (37.0%) reported 563 adverse events (AEs); 15 AEs in 14 patients (2.9%) were considered treatment related. Sixty-nine patients (14.3%) reported 137 serious AEs; 3 serious AEs in 2 patients (0.4%) were considered treatment related. No new safety signals were identified.

Conclusions: ASPIRE captured the real-world individualized nature of onabotulinumtoxinA utilization for upper limb spasticity over 2?years, with consistently high clinician- and patient-reported satisfaction. Data in this primary analysis will guide clinical use of onabotulinumtoxinA, as well as provide insights to improve educational programs on spasticity management.

SUBMITTER: Francisco GE

PROVIDER: S-EPMC7687094 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study.

Francisco Gerard E GE Jost Wolfgang H WH Bavikatte Ganesh G Bandari Daniel S DS Tang Simon F T SFT Munin Michael C MC Largent Joan J Adams Aubrey M AM Zuzek Aleksej A Esquenazi Alberto A

PM & R : the journal of injury, function, and rehabilitation 20200227 11

<h4>Introduction</h4>OnabotulinumtoxinA treatment for spasticity is dependent on numerous factors and varies according to selected treatment goals.<h4>Objective</h4>To examine real-world onabotulinumtoxinA treatment utilization and effectiveness in patients with upper limb spasticity over 2 years from the Adult Spasticity International Registry (ASPIRE) study.<h4>Design</h4>Multicenter, prospective, observational registry (NCT01930786).<h4>Setting</h4>Fifty-four international clinical sites in N ...[more]

PMID: 31953896

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Project description:Etiology-specific onabotulinumtoxinA utilization to manage spasticity is largely unknown. In this 1-year interim analysis, we evaluated real-world onabotulinumtoxinA utilization and effectiveness across several etiologies from the Adult Spasticity International Registry (ASPIRE) study. ASPIRE is a multicenter, prospective, observational registry (NCT01930786) examining stroke, multiple sclerosis [MS], cerebral palsy [CP], traumatic brain injury [TBI], and spinal cord injury [SCI] patients with spasticity treated with onabotulinumtoxinA at the clinician's discretion. Assessments included onabotulinumtoxinA utilization (each session), clinician (subsequent session)/patient (5±1 weeks post-treatment) satisfaction, and the Disability Assessment Scale (DAS; subsequent session). 730 patients received ≥1 onabotulinumtoxinA treatment, with 37% naïve to botulinum toxin(s) for spasticity. The most common etiology was stroke (n=411, 56%), followed by MS (N=119, 16%), CP (N=77, 11%), TBI (N=45, 6%), and SCI (N=42, 6%). The total body mean cumulative dose (±SD) of onabotulinumtoxinA per session ranged from 296 U (±145) in CP to 406 U (±152) in TBI. The most commonly treated upper limb presentations were clenched fist (stroke, MS, and SCI), flexed wrist (CP), and flexed elbow (TBI). Equinovarus foot was the most commonly treated lower limb presentation in all etiologies. Stroke patients showed improved DAS scores for nearly all subscales in both limbs, indicative of improved global function. All etiologies showed improved lower limb mobility DAS scores. Across all sessions, clinicians (range: 87.4% [SCI]-94.2% [CP]) and patients (range: 67.6% [TBI]-89.7% [SCI]) reported extreme satisfaction/satisfaction that onabotulinumtoxinA helped manage spasticity, and clinicians (range: 94.6% [TBI]-98.8% [CP]) and patients (range: 88.4% [stroke]-91.2% [TBI]) would definitely/probably continue treatment. Treatment-related adverse events (TRAEs) and treatment-related serious adverse events (TRSAEs) were reported as follows: stroke: 10 TRAEs (2.2% patients), 3 TRSAEs (0.5%); MS: 5 TRAEs (4.2%), 0 TRSAEs; CP: 0 TRAEs, 0 TRSAEs; TBI: 1 TRAEs (2.2%), 0 TRSAEs; SCI: 0 TRAEs, 0 TRSAEs. No new safety signals were identified. High clinician- and patient-reported satisfaction were observed following individualized onabotulinumtoxinA treatment, as well as improved global function. Interim results from ASPIRE demonstrate etiology-specific similarities and differences in clinical approaches to manage spasticity.

Dataset Information

Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study.

Publications

Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study.

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