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.

© 2020 The Authors. PM&R published by Wiley Periodicals, Inc. on behalf of American Academy of Physical Medicine and Rehabilitation.

Figures

Figure 1

Primary etiology of spasticity at baseline in the upper limb spasticity population. For each population shown (ie, naïve, non‐naïve, and total), percentages sum to 100% across etiologies. Etiologies were not mutually exclusive, as more than one response was allowed per patient. †Stroke includes ischemic, hemorrhagic, and embolic stroke. ‡Other includes hereditary spastic paraparesis, stroke during aneurysm clipping, chiari malformation, and hydrocephalus. CP, cerebral palsy; MS, multiple sclerosis; N, number of patients; TBI, traumatic brain injury; SCI, spinal cord injury.

Figure 2

Severity of spasticity at baseline in the upper limb spasticity population. Severity of spasticity was determined at baseline for each clinical presentation using the Modified Modified Ashworth Scale (MMAS 34 ). Data shown within the figure represents the mean MMAS score at baseline across all upper limb clinical presentations. For each population shown (ie, naïve, non‐naïve, and total), percentages sum to 100% across MMAS categories. MMAS data are missing for 12 patients (2 naïve, 10 non‐naïve). N, number of patients.

Figure 3

Muscles injected with onabotulinumtoxinA for the treatment of upper limb spasticity, stratified by clinical presentation. Clinical presentations are listed in order of number of patients treated: highest to lowest. Upper limb spasticity presentations, and muscles within each presentation, are not mutually exclusive, and therefore, categories may sum to >100%. Data for “other” clinical presentations and “other” muscles not predefined within the case report form, including for nonspasticity indications, are not shown. n, number of treatment sessions per clinical presentation or muscle injected.

Figure 4

Adjustments to muscles targeted and dose of onabotulinumtoxinA at time of re‐treatment in the upper limb spasticity population. At the time of re‐treatment, clinicians were asked (A) if the muscles treated changed from the last treatment session and (B) if the dose was adjusted from the last treatment session (shown in black box). Of those clinicians that responded “yes” to the questions above, the top 3 reasons cited for this decision (excluding “other”) are provided in rank order (shown in gray box), where more than one reason was allowed. n, number of treatment sessions; Tx, treatment session.

Figure 5

Numeric Pain Rating Scale (NPRS) in the upper limb spasticity population. NPRS is a common scale that is used to assess pain intensity using an 11‐point rating scale (range: 0‐10), where “0” represents no pain and a “10” represents the worst pain imaginable. 36 , 37 NPRS was reported by the patient at baseline (prior to treatment) and 5 ± 1 weeks post‐treatment via phone or web. Mean change in NPRS scores vs baseline are shown. *Indicates statistically significant change from baseline at P < .006 (Bonferroni correction applied). N, number of patients; Tx, treatment session.

Figure 6

Clinician‐reported satisfaction with onabotulinumtoxinA treatment in the upper limb spasticity population. At the subsequent treatment session, clinicians were asked a series of questions to determine their satisfaction with the previous onabotulinumtoxinA (referred to as BOTOX in the original questionnaire) treatment for spasticity. Therefore, data on clinician satisfaction at the final treatment session and/or treatment session 8 were not gathered. For figures (B) and (D), the percentage of clinicians was recalculated to exclude those that indicated that the question was “not applicable.” Data presented as percentage of treatment sessions. n, number of treatment sessions; Tx, treatment session.

Figure 7

Patient‐reported satisfaction with onabotulinumtoxinA treatment in the upper limb spasticity population. Patients were asked a series of questions to determine their satisfaction with onabotulinumtoxinA (referred to as BOTOX in the original questionnaire) treatment for spasticity 5 ± 1 weeks post‐treatment via phone or web. For figures (B), (C), and (H), the percentage of patients was recalculated to exclude those that indicated that the question was “not applicable.” Data presented as percentage of treatment sessions. n, number of treatment sessions; Tx, treatment session.