Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA
Abstract Background We evaluated quality of life among subjects with upper- and lower-limb spasticity who received escalating doses of incobotulinumtoxinA (total body doses up to 800 U) in the prospective, single-arm, dose-titration TOWER study. Methods In this exploratory trial, subjects (N = 155;...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-03-01
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| Series: | Health and Quality of Life Outcomes |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12955-020-01304-4 |
| _version_ | 1818117080835162112 |
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| author | Klemens Fheodoroff Tiina Rekand Luisa Medeiros Peter Koßmehl Jörg Wissel Djamel Bensmail Astrid Scheschonka Birgit Flatau-Baqué Olivier Simon Dirk Dressler David M. Simpson |
| author_facet | Klemens Fheodoroff Tiina Rekand Luisa Medeiros Peter Koßmehl Jörg Wissel Djamel Bensmail Astrid Scheschonka Birgit Flatau-Baqué Olivier Simon Dirk Dressler David M. Simpson |
| author_sort | Klemens Fheodoroff |
| collection | DOAJ |
| description | Abstract Background We evaluated quality of life among subjects with upper- and lower-limb spasticity who received escalating doses of incobotulinumtoxinA (total body doses up to 800 U) in the prospective, single-arm, dose-titration TOWER study. Methods In this exploratory trial, subjects (N = 155; 18–80 years of age) with upper- and lower-limb spasticity due to cerebral causes who were deemed to require total body doses of up to 800 U incobotulinumtoxinA received three consecutive injection cycles of incobotulinumtoxinA (400, 600, and up to 800 U), each with 12 to 16 weeks’ follow-up. QoL was assessed using the EuroQol 5-dimensions questionnaire, three-level (EQ-5D), before and 4 weeks post-injection in each injection cycle and at the end of injection cycle 3. Results The mean EQ-5D visual analog scale scores of 155 participants continuously improved from study baseline to 4 weeks post-injection in all injection cycles (mean [standard deviation] change 6.7 [14.1], 9.6 [16.3], and 8.6 [17.0] for injection cycles 1, 2, and 3, respectively; p < 0.0001 for all, paired sample t-test). In general, among those with a change in the EQ-5D rating of their condition, the proportion of subjects with ‘improvement’ was greater than that with ‘worsening’ for individual EQ-5D dimensions across all injection cycles. At the end of injection cycle 3, the proportion of subjects rating their condition as ‘normal’ increased from study baseline for all dimensions, and there was a ≥ 46% reduction in the proportion of subjects with a rating of ‘severe impairment’. Conclusion These preliminary results suggest that escalating incobotulinumtoxinA doses up to 800 U are associated with improvement in quality of life ratings in subjects with multifocal upper- and lower-limb spasticity, and form a basis for future comparator studies. Trial registration ClinicalTrials.gov, NCT01603459 . Date of registration: May 22, 2012. |
| first_indexed | 2024-12-11T04:32:44Z |
| format | Article |
| id | doaj.art-eafdcd9cdbd24c58acc762033f305219 |
| institution | Directory Open Access Journal |
| issn | 1477-7525 |
| language | English |
| last_indexed | 2024-12-11T04:32:44Z |
| publishDate | 2020-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Health and Quality of Life Outcomes |
| spelling | doaj.art-eafdcd9cdbd24c58acc762033f3052192022-12-22T01:20:49ZengBMCHealth and Quality of Life Outcomes1477-75252020-03-0118111010.1186/s12955-020-01304-4Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinAKlemens Fheodoroff0Tiina Rekand1Luisa Medeiros2Peter Koßmehl3Jörg Wissel4Djamel Bensmail5Astrid Scheschonka6Birgit Flatau-Baqué7Olivier Simon8Dirk Dressler9David M. Simpson10Gailtal-KlinikHaukeland University HospitalCentro Hospitalar de Lisboa CentralKliniken Beelitz GmbH, Beelitz-HeilstättenVivantes Hospital SpandauRaymond-Poincaré Hospital, AP-HP, University of Versailles Saint QuentinMerz Pharmaceuticals GmbHMerz Pharmaceuticals GmbHFormerly of Merz Pharmaceuticals GmbHHannover Medical SchoolIcahn School of Medicine at Mount Sinai, New YorkAbstract Background We evaluated quality of life among subjects with upper- and lower-limb spasticity who received escalating doses of incobotulinumtoxinA (total body doses up to 800 U) in the prospective, single-arm, dose-titration TOWER study. Methods In this exploratory trial, subjects (N = 155; 18–80 years of age) with upper- and lower-limb spasticity due to cerebral causes who were deemed to require total body doses of up to 800 U incobotulinumtoxinA received three consecutive injection cycles of incobotulinumtoxinA (400, 600, and up to 800 U), each with 12 to 16 weeks’ follow-up. QoL was assessed using the EuroQol 5-dimensions questionnaire, three-level (EQ-5D), before and 4 weeks post-injection in each injection cycle and at the end of injection cycle 3. Results The mean EQ-5D visual analog scale scores of 155 participants continuously improved from study baseline to 4 weeks post-injection in all injection cycles (mean [standard deviation] change 6.7 [14.1], 9.6 [16.3], and 8.6 [17.0] for injection cycles 1, 2, and 3, respectively; p < 0.0001 for all, paired sample t-test). In general, among those with a change in the EQ-5D rating of their condition, the proportion of subjects with ‘improvement’ was greater than that with ‘worsening’ for individual EQ-5D dimensions across all injection cycles. At the end of injection cycle 3, the proportion of subjects rating their condition as ‘normal’ increased from study baseline for all dimensions, and there was a ≥ 46% reduction in the proportion of subjects with a rating of ‘severe impairment’. Conclusion These preliminary results suggest that escalating incobotulinumtoxinA doses up to 800 U are associated with improvement in quality of life ratings in subjects with multifocal upper- and lower-limb spasticity, and form a basis for future comparator studies. Trial registration ClinicalTrials.gov, NCT01603459 . Date of registration: May 22, 2012.http://link.springer.com/article/10.1186/s12955-020-01304-4Botulinum neurotoxinIncobotulinumtoxinALong-term careLower limbQuality of lifeSpasticity |
| spellingShingle | Klemens Fheodoroff Tiina Rekand Luisa Medeiros Peter Koßmehl Jörg Wissel Djamel Bensmail Astrid Scheschonka Birgit Flatau-Baqué Olivier Simon Dirk Dressler David M. Simpson Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA Health and Quality of Life Outcomes Botulinum neurotoxin IncobotulinumtoxinA Long-term care Lower limb Quality of life Spasticity |
| title | Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA |
| title_full | Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA |
| title_fullStr | Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA |
| title_full_unstemmed | Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA |
| title_short | Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA |
| title_sort | quality of life in subjects with upper and lower limb spasticity treated with incobotulinumtoxina |
| topic | Botulinum neurotoxin IncobotulinumtoxinA Long-term care Lower limb Quality of life Spasticity |
| url | http://link.springer.com/article/10.1186/s12955-020-01304-4 |
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