•Analyses reveal key clinical variables associated with onabotulinumtoxinA adherence.•Key adherent variables: used orthotics and treated in Europe.•Key nonadherent variables: retreatment ≥15 weeks, ...used assistive devices, Disability Assessment Scale pain.•Most patients adhered to onabotulinumtoxinA, >5 sessions in 2 years for adherents.•Real-world evidence from the Adult Spasticity International Registry study can enhance spasticity patient care.
To identify baseline characteristics and treatment-related variables that affect adherence to onabotulinumtoxinA treatment from the Adult Spasticity International Registry (ASPIRE) study.
Prospective, observational registry (NCT01930786).
International clinical sites.
Adults with spasticity (N=730).
OnabotulinumtoxinA at clinician's discretion.
Clinically meaningful thresholds used for treatment adherent (≥3 treatment sessions during 2-year study) and nonadherent (≤2 sessions). Data analyzed using logistic regression and presented as odds ratios (ORs) with 95% confidence intervals (CIs). Treatment-related variables assessed at sessions 1 and 2 only.
Of the total population, 523 patients (71.6%) were treatment adherent with 5.3±1.6 sessions and 207 (28.4%) were nonadherent with 1.5±0.5 sessions. In the final model (n=626/730), 522 patients (83.4%) were treatment adherent and 104 (16.6%) were nonadherent. Baseline characteristics associated with adherence: treated in Europe (OR=1.84; CI, 1.06-3.21; P=.030) and use of orthotics (OR=1.88; CI, 1.15-3.08; P=.012). Baseline characteristics associated with nonadherence: history of diplopia (OR=0.28; CI, 0.09-0.89; P=.031) and use of assistive devices (OR=0.51; CI, 0.29-0.90; P=.021). Treatment-related variables associated with nonadherence: treatment interval ≥15 weeks (OR=0.43; CI, 0.26-0.72; P=.001) and clinician dissatisfaction with onabotulinumtoxinA to manage pain (OR=0.18; CI, 0.05-0.69; P=.012). Of the population with stroke (n=411), 288 patients (70.1%) were treatment adherent with 5.3±1.6 sessions and 123 (29.9%) were nonadherent with 1.5±0.5 session. In the final stroke model (n=346/411), 288 patients (83.2%) were treatment adherent and 58 (16.8%) were nonadherent. Baseline characteristics associated with adherence: treated in Europe (OR=2.99; CI, 1.39-6.44; P=.005) and use of orthotics (OR=3.18; CI, 1.57-6.45; P=.001). Treatment-related variables associated with nonadherence: treatment interval ≥15 weeks (OR=0.42; CI, 0.21-0.83; P=.013) and moderate/severe disability on upper limb Disability Assessment Scale pain subscale (OR=0.40; CI, 0.19-0.83; P=.015).
These ASPIRE analyses demonstrate real-world patient and clinical variables that affect adherence to onabotulinumtoxinA and provide insights to help optimize management strategies to improve patient care.
The main aim of this study was to determine the utilization patterns and effectiveness of onabotulinumtoxinA (Botox®) for treatment of spasticity in clinical practice.
An international, multicentre, ...prospective, observational study at selected sites in North America, Europe, and Asia.
Adult patients with newly diagnosed or established focal spasticity, including those who had previously received treatment with onabotulinum-toxin A.
Patients were treated with onabotulinumtoxinA, approximately every 12 weeks, according to their physician's usual clinical practice over a period of up to 96 weeks, with a final follow-up interview at 108 weeks. Patient, physician and caregiver data were collected.
Baseline characteristics are reported. Of the 745 patients enrolled by 75 healthcare providers from 54 sites, 474 patients had previously received onabotulinumtoxinA treatment for spasticity. Lower limb spasticity was more common than upper limb spasticity, with stroke the most common underlying aetiology. The Short-Form 12 (SF-12) health survey scores showed that patients' spasticity had a greater perceived impact on physical rather than mental aspects.
The data collected in this study will guide the development of administration strategies to optimize the effectiveness of onabotulinumtoxinA in the management of spasticity of various underlying aetiologies.
Introduction
OnabotulinumtoxinA treatment for spasticity varies according to numerous factors and is individualized to meet treatment goals.
Objective
To explore real‐world onabotulinumtoxinA ...utilization and effectiveness in patients with lower limb spasticity from the Adult Spasticity International Registry (ASPIRE) study.
Design
Two‐year, multicenter, prospective, observational registry (NCT01930786).
Setting
Fifty‐four international clinical sites.
Patients
Adults (naïve or non‐naïve to botulinum toxins treatment for spasticity, across multiple etiologies) with lower limb spasticity related to upper motor neuron syndrome.
Interventions
OnabotulinumtoxinA administered at the clinician's discretion.
Main Outcome Measures
OnabotulinumtoxinA treatment utilization, clinician‐ and patient‐reported satisfaction.
Results
In 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.
Conclusions
ASPIRE 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.
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.
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.
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•ASPIRE found etiology-specific similarities and differences in real-world onabotulinumtoxinA utilization for spasticity.•Across all etiologies, there was high clinician- and patient-reported satisfaction with onabotulinumtoxinA treatment.•In DAS, all etiologies showed improved global function in lower limb mobility following onabotulinumtoxinA treatment.•Adverse event data varied by etiology of spasticity; however, no new safety signals were identified.•ASPIRE data may guide clinical strategies and educational programs to improve onabotulinumtoxinA spasticity management.
In patients with relapsing-remitting multiple sclerosis (RRMS), subcutaneous (sc) interferon (IFN)β-1a and IFNβ-1b have been shown to reduce relapse rates. A formulation of IFNβ-1a has been produced ...without fetal bovine serum and without human serum albumin as an excipient (not currently approved for use in the US). The objectives of this study were to evaluate tolerability, injection-site redness, subject-reported satisfaction with therapy, and clinical safety and efficacy of the serum-free formulation of IFNβ-1a versus IFNβ-1b in IFNβ-treatment-naïve patients with RRMS. The objectives of the extension phase were to evaluate long-term safety and tolerability of IFNβ-1a.
This randomized, parallel-group, open-label study was conducted at 27 clinical sites in the US. Eligible patients aged 18-60 years were randomized to receive either IFNβ-1a, titrated to 44 μg sc three times weekly (tiw) (n = 65), or IFNβ-1b, titrated to 250 μg sc every other day (n = 64) over 12 weeks. Following this, all patients received IFNβ-1a 44 μg tiw for 82-112 weeks. Primary endpoint was mean change in patient-reported pain, as assessed by visual analog scale (VAS) diary pain score (from 0 mm no pain to 100 mm worst possible pain) at the injection site, from pre-injection to 30 min post-injection over the first 21 full-dose injections. Secondary assessments included proportion of patients pain-free as recorded by VAS diary and the Short-Form McGill Pain questionnaire VAS.
A total of 129 patients were included in the intent-to-treat analysis. Mean (standard deviation) change in VAS diary pain score was not significantly different between groups, although numerically lower with IFNβ-1a versus IFNβ-1b from pre-injection to immediately post-injection (1.46 2.93 vs. 4.63 10.57 mm), 10 min post-injection (0.70 1.89 vs. 1.89 5.75 mm), and 30 min post-injection (0.67 2.32 vs. 1.14 4.94 mm). Proportion of patients pain-free at all time periods post-injection was also not significantly different between groups. Adverse events were consistent with the known safety profiles of these treatments.
In IFNβ-treatment-naïve patients with RRMS, both the serum-free formulation of IFNβ-1a and IFNβ-1b treatments were generally accompanied by low-level injection-site pain and were well tolerated.
ClinicalTrials.gov NCT00428584.
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