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Spasticity in practice (SPACE): an international non-interventional study of botulinum neurotoxin type A in treatment-naïve subjects with spasticity
Affiliations- IRMA: Independent Rehabilitation Medicine Assessment, London, United Kingdom
- Hôpital Raymond Poincaré, Garches, France
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
- Federal State Hospital for Treatment and Rehabilitation, Ministry of Health, Moscow, Russian Federation
- Sahlgrenska Universitetssjukhuset/Högsbo, Göteborg, Sweden
- DKD HELIOS clinic Wiesbaden, Wiesbaden, Germany
- formerly of Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany
- Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany
- Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany
- Parkinson-Klinik Ortenau, Wolfach, Germany
- University of Freiburg, Freiburg/Breisgau, Germany
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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.
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.
Keywords
botulinum neurotoxin A, rehabilitation, muscle spasticity, quality of life
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About this articleTitle
Spasticity in practice (SPACE): an international non-interventional study of botulinum neurotoxin type A in treatment-naïve subjects with spasticity
Journal
Neurologia i Neurochirurgia Polska
Issue
Article type
Research Paper
Pages
165-173
Published online
2021-01-12
Page views
1458
Article views/downloads
1206
DOI
Pubmed
Bibliographic record
Neurol Neurochir Pol 2021;55(2):165-173.
Keywords
botulinum neurotoxin A
rehabilitation
muscle spasticity
quality of life
Authors
Julian Harriss
Nicolas Roche
Carlos Cantú-Brito
Svetlana Khatkova
Patrik Säterö
Susanne Heitmann
Olivier Simon
Christine Kliebe-Frisch
Georg Comes
Wolfgang H. Jost
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