Spasticity in practice (SPACE): an international non-interventional study of botulinum neurotoxin type A in treatment-naïve subjects with spasticity

Abstract

Aim of the study. SPACE, a prospective, non-interventional, open-label, multinational study, investigated physicians' and subjects' assessment of safety, efficacy, and health-related quality of life (HRQoL) following botulinum neurotoxin type A (BoNT-A) treatment to understand real-world clinical usage for the management of focal and multifocal spasticity. Clinical rationale for the study. Treatment guidelines recommend the use of BoNT-A for the management of spasticity in adults. This study assessed how physicians use BoNT-A therapy in real-world clinical practice, and provided evidence on long-term safety and efficacy over a period of up to 2 years. Materials and methods. BoNT treatment-naïve adults with spasticity of any aetiology received any BoNT-A formulation at their physician's discretion, and were observed for ≤ 8 treatment cycles (≤ 2 years). Daily practice information, physician's global assessments of tolerability and efficacy, and HRQoL were documented. Incidences of adverse drug reactions or all adverse events were documented for non-Mexican subjects and for Mexican subjects, respectively, due to protocol differences based on local regulatory requirements. Results. A total of 701 subjects were enrolled (safety population; nine countries). Physicians rated the tolerability of BoNT-A as 'very good' or 'good' for 88.2-97.4% of subjects throughout the study (subject numbers declined throughout this non-interventional study). Adverse drug reactions were reported for 16/600 (2.7%) of the non-Mexican subjects, with two considered to be 'definitely related' to treatment (injection-site haematoma, n = 1; botulism, n = 1). For 687 subjects, efficacy was rated 'very good' or 'good' by most physicians and subjects. Improvements in HRQoL were observed. Conclusions and clinical implications. Throughout this 2-year study, BoNT-A treatment was generally well-tolerated, effective, and associated with an improved HRQoL. This study makes a valuable contribution to the broader understanding of how physicians use BoNT-A therapy to manage spasticity in real-world clinical practice.

Selecting Goals and Target Muscles for Botulinum Toxin A Injection Using the Goal Oriented Facilitated Approach to Spasticity Treatment (GO-FAST) Tool

“…Therefore, the management of spasticity is crucial in post-stroke care. The injection of botulinum toxin A (BoNT-A), a protein neurotoxin derived from Clostridium botulinum, is one of the most effective and well-established therapies for post-stroke spasticity [ 5 , 6 , 7 ]. The management of spasticity is challenging due to the diversity of patient presentations, functional status, expectations, and treatment goals [ 1 ].…”

The effectiveness and safety of repetitive transcranial magnetic stimulation on spasticity after upper motor neuron injury: A systematic review and meta-analysis

“…Patients with long-term spasticity usually accompany with depression, anxiety, bipolar disorder, and other mood disorders ( Chen et al, 2013 ; Kes et al, 2013 ). The common pharmacological treatments for spasticity are oral muscle relaxants ( Yelnik et al, 2009 ; Sommerfeld et al, 2012 ), intrathecal baclofen ( Ertzgaard et al, 2017 ; Creamer et al, 2018 ), and botulinum neurotoxin injections ( Chen et al, 2020 ; Harriss et al, 2021 ). However, the efficacy of antispastic drugs is limited, and long-term medication may cause undesirable side effects, such as drowsiness, cognitive impairment, and muscle weakness ( Langhorne et al, 2011 ; Turner-Stokes et al, 2015 ).…”