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

ACCESS DATA

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.

Project description:IntroductionOnabotulinumtoxinA treatment for spasticity varies according to numerous factors and is individualized to meet treatment goals.ObjectiveTo explore real-world onabotulinumtoxinA utilization and effectiveness in patients with lower limb spasticity from the Adult Spasticity International Registry (ASPIRE) study.DesignTwo-year, multicenter, prospective, observational registry (NCT01930786).SettingFifty-four international clinical sites.PatientsAdults (naïve or non-naïve to botulinum toxin[s] treatment for spasticity, across multiple etiologies) with lower limb spasticity related to upper motor neuron syndrome.InterventionsOnabotulinumtoxinA administered at the clinician's discretion.Main outcome measuresOnabotulinumtoxinA treatment utilization, clinician- and patient-reported satisfaction.ResultsIn ASPIRE, 530 patients received ≥1 onabotulinumtoxinA treatment for lower limb spasticity (mean age, 52 years; stroke, 49.4%; multiple sclerosis, 20.4%). Equinovarus foot was treated most often (80.9% of patients), followed by flexed knee (26.0%), stiff extended knee (22.5%), and flexed toes (22.3%). OnabotulinumtoxinA doses ranged between 10 and 1100 U across all presentations. Electromyography (EMG) was most commonly used for injection localization (≥41.1% of treatment sessions). Despite low patient response on the satisfaction questionnaire, clinicians (94.6% of treatment sessions) and patients (84.5%) reported satisfaction/extreme satisfaction that treatment helped manage spasticity, and clinicians (98.3%) and patients (91.6%) would probably/definitely continue onabotulinumtoxinA treatment. These data should be interpreted with care. Twenty-one adverse events (AEs) in 18 patients (3.4%) were considered treatment-related. Sixty-seven patients (12.6%) reported 138 serious AEs; 3 serious AEs in two patients (0.4%) were considered treatment-related. No new safety signals were identified.ConclusionsASPIRE provides long-term observational data on the treatment of lower limb spasticity with onabotulinumtoxinA. Real-world data from this primary analysis can help to guide the clinical use of onabotulinumtoxinA to improve spasticity management.

Project description:Introduction: Spasticity is the main complication of many upper motor neuron disorders. Many studies describe neuro-orthopedic surgeries for the correction of joint and limb deformities due to spasticity, though less in the upper extremity. The bulk of care provided to patients with spasticity is provided by rehabilitation clinicians, however, few of the surgical outcomes have been summarized or appraised in the rehabilitation literature. Objective: To review the literature for neuro-orthopedic surgical techniques in the upper limb and evaluate the level of evidence for their efficacy in adult patients with spasticity. Method: Electronic databases of MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews were searched for English, French as well as Farsi languages human studies from 1980 to July 2, 2020. After removing duplicated articles, 2,855 studies were screened and 80 were found to be included based on the criteria. The studies were then divided into two groups, with 40 in each trial and non-trial. The results of the 40 trial articles were summarized in three groups: shoulder, elbow and forearm, and wrist and finger, and each group was subdivided based on the types of intervention. Results: The level of evidence was evaluated by Sackett's approach. There were no randomized control trial studies found. About, 4 studies for shoulder, 8 studies for elbow and forearm, 26 studies for wrist and finger (including 4 for the thumb in palm deformity), and 2 systematic reviews were found. Around, two out of 40 trial articles were published in the rehabilitation journals, one systematic review in Cochrane, and the remaining 38 were published in the surgical journals. Conclusion: Most surgical procedures are complex, consisting of several techniques based on the problems and goals of the patient. This complexity interferes with the evaluation of every single procedure. Heterogenicity of the participants and the absence of clinical trial studies are other factors of not having a single conclusion. This review reveals that almost all the studies suggested good results after the surgery in carefully selected cases with goals of reducing spasticity and improvement in function, pain, hygiene, and appearance. A more unified approach and criteria are needed to facilitate a collaborative, evidence-based, patient referral, and surgical selection pathway.

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.

Introduction

Objective

Design

Setting

Patients

Interventions

Main outcome measures

Results

Conclusions

Publications

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

Similar Datasets

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