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

• Published in: Neurologia i neurochirurgia polska 2021-01, Vol.55 (2), p.165-173
• Main Authors: Harriss, Julian, Roche, Nicolas, Cantú-Brito, Carlos, Khatkova, Svetlana, Säterö, Patrik, Heitmann, Susanne, Simon, Olivier, Kliebe-Frisch, Christine, Comes, Georg, Jost, Wolfgang H
• Format: Article
• Language: English
• Subjects: Adult; Botulinum Toxins, Type A - therapeutic use; Clinical medicine; Humans; Muscle Spasticity - drug therapy; Neuromuscular Agents - therapeutic use; Neurotoxicity; Physicians; Prospective Studies; Quality of Life; Spasticity; Treatment Outcome
• ISSN: 0028-3843; 1897-4260
• DOI: 10.5603/PJNNS.a2021.0001

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. 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. 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. 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. 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.