Long‐term observational results from the ASPIRE study: onabotulinumtoxinA treatment for adult lower limb spasticity

Abstract: 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 toxin[s] 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

Angaben zum Objekt

• Standort: Deutsche Nationalbibliothek Frankfurt am Main
• Umfang: Online-Ressource
• Sprache: Englisch
• Anmerkungen: PM&R : the journal of injury, function and rehabilitation. - 13, 10 (2021) , 1079-1093, ISSN: 1934-1563

Klassifikation und Themen

• Klassifikation: Medizin, Gesundheit

Beteiligte, Orts- und Zeitangaben

• Ereignis: Veröffentlichung
• (wo): Freiburg
• (wer): Universität
• (wann): 2024
• Urheber: Esquenazi, Alberto ; Bavikatte, Ganesh ; Bandari, Daniel S. ; Jost, Wolfgang H. ; Munin, Michael C. ; Tang, Simon F. T. ; Largent, Joan ; Adams, Aubrey Manack ; Zuzek, Aleks ; Francisco, Gerard E.

Weitere Informationen

• DOI: 10.1002/pmrj.12517
• URN: urn:nbn:de:bsz:25-freidok-2475221
• Rechteinformation: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Letzte Aktualisierung: 25.03.2025, 13:49 MEZ