AbobotulinumtoxinA (Dysport®) Improves Function According to Goal Attainment in Children With Dynamic Equinus Due to Cerebral Palsy
This secondary analysis of a large (n = 241), randomized, double-blind study evaluated the efficacy of 2 doses of abobotulinumtoxinA + standard of care (SOC) versus placebo + SOC in enabling children with dynamic equinus due to cerebral palsy to achieve their functional goals using Goal Attainment S...
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| Published in: | Journal of child neurology Vol. 32; no. 5; pp. 482 - 487 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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01-04-2017
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| Abstract | This secondary analysis of a large (n = 241), randomized, double-blind study evaluated the efficacy of 2 doses of abobotulinumtoxinA + standard of care (SOC) versus placebo + SOC in enabling children with dynamic equinus due to cerebral palsy to achieve their functional goals using Goal Attainment Scaling. Most parents/caregivers selected goals targeting aspects of gait improvement as most relevant. Mean (95% confidence interval) Goal Attainment Scaling T scores at week 4 were higher for both abobotulinumtoxinA groups versus placebo (treatment difference vs placebo: 10 U/kg/leg: 5.32 [2.31, 8.32], P = .0006, and 15 U/kg/leg 4.65 [1.59, 7.71], P = .0031). Superiority of both abobotulinumtoxinA doses versus placebo was maintained at week 12. Best goal attainment T scores were higher in the abobotulinumtoxinA groups versus placebo for the common goals of improved walking pattern, decreased falling, decreased tripping, and improved endurance. These findings demonstrate that single injections of abobotulinumtoxinA (10 and 15 U/kg/leg) significantly improved the ability of pediatric cerebral palsy patients to achieve their functional goals. |
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| AbstractList | This secondary analysis of a large (n = 241), randomized, double-blind study evaluated the efficacy of 2 doses of abobotulinumtoxinA + standard of care (SOC) versus placebo + SOC in enabling children with dynamic equinus due to cerebral palsy to achieve their functional goals using Goal Attainment Scaling. Most parents/caregivers selected goals targeting aspects of gait improvement as most relevant. Mean (95% confidence interval) Goal Attainment Scaling T scores at week 4 were higher for both abobotulinumtoxinA groups versus placebo (treatment difference vs placebo: 10 U/kg/leg: 5.32 [2.31, 8.32], P = .0006, and 15 U/kg/leg 4.65 [1.59, 7.71], P = .0031). Superiority of both abobotulinumtoxinA doses versus placebo was maintained at week 12. Best goal attainment T scores were higher in the abobotulinumtoxinA groups versus placebo for the common goals of improved walking pattern, decreased falling, decreased tripping, and improved endurance. These findings demonstrate that single injections of abobotulinumtoxinA (10 and 15 U/kg/leg) significantly improved the ability of pediatric cerebral palsy patients to achieve their functional goals. This secondary analysis of a large (n = 241), randomized, double-blind study evaluated the efficacy of 2 doses of abobotulinumtoxinA + standard of care (SOC) versus placebo + SOC in enabling children with dynamic equinus due to cerebral palsy to achieve their functional goals using Goal Attainment Scaling. Most parents/caregivers selected goals targeting aspects of gait improvement as most relevant. Mean (95% confidence interval) Goal Attainment Scaling T scores at week 4 were higher for both abobotulinumtoxinA groups versus placebo (treatment difference vs placebo: 10 U/kg/leg: 5.32 [2.31, 8.32], P = .0006, and 15 U/kg/leg 4.65 [1.59, 7.71], P = .0031). Superiority of both abobotulinumtoxinA doses versus placebo was maintained at week 12. Best goal attainment T scores were higher in the abobotulinumtoxinA groups versus placebo for the common goals of improved walking pattern, decreased falling, decreased tripping, and improved endurance. These findings demonstrate that single injections of abobotulinumtoxinA (10 and 15 U/kg/leg) significantly improved the ability of pediatric cerebral palsy patients to achieve their functional goals. |
| Author | Tse, Anissa Picaut, Philippe Tilton, Ann Kutlay, Sehim Escobar, Raul G. Russman, Barry Lipczyk, Zbigniew Delgado, Mauricio R. Aydin, Resa Grandoulier, Anne-Sophie Dincer, Umit Velez, Juan Carlos |
| AuthorAffiliation | 4 GATA Haydarpasa Training Hospital, Istanbul, Turkey 10 University of Texas Southwestern Medical Center and Texas Scottish Rite Hospital for Children, Dallas, TX, USA 3 Istanbul University, Istanbul, Turkey 6 Department of PMR, Ankara University, Faculty of Medicine, Ankara, Turkey 2 Shriner’s Hospital for Children, Portland, OR, USA 5 Unit of Neurology, Division of Pediatrics, Medical School, Pontificia Universidad Catolica de Chile, Santiago, Chile 7 B and L–Specialist Medical Centre, Lodz, Poland 8 Club De Leones Cruz Del Sur Rehabilitation Center, Punta Arenas, Chile 9 Ipsen, Les Ulis, France 1 LSUHSC and Children’s Hospital New Orleans, New Orleans, LA, USA |
| AuthorAffiliation_xml | – name: 2 Shriner’s Hospital for Children, Portland, OR, USA – name: 8 Club De Leones Cruz Del Sur Rehabilitation Center, Punta Arenas, Chile – name: 6 Department of PMR, Ankara University, Faculty of Medicine, Ankara, Turkey – name: 9 Ipsen, Les Ulis, France – name: 5 Unit of Neurology, Division of Pediatrics, Medical School, Pontificia Universidad Catolica de Chile, Santiago, Chile – name: 4 GATA Haydarpasa Training Hospital, Istanbul, Turkey – name: 1 LSUHSC and Children’s Hospital New Orleans, New Orleans, LA, USA – name: 3 Istanbul University, Istanbul, Turkey – name: 7 B and L–Specialist Medical Centre, Lodz, Poland – name: 10 University of Texas Southwestern Medical Center and Texas Scottish Rite Hospital for Children, Dallas, TX, USA |
| Author_xml | – sequence: 1 givenname: Ann surname: Tilton fullname: Tilton, Ann – sequence: 2 givenname: Barry surname: Russman fullname: Russman, Barry – sequence: 3 givenname: Resa surname: Aydin fullname: Aydin, Resa – sequence: 4 givenname: Umit surname: Dincer fullname: Dincer, Umit – sequence: 5 givenname: Raul G. surname: Escobar fullname: Escobar, Raul G. – sequence: 6 givenname: Sehim surname: Kutlay fullname: Kutlay, Sehim – sequence: 7 givenname: Zbigniew surname: Lipczyk fullname: Lipczyk, Zbigniew – sequence: 8 givenname: Juan Carlos surname: Velez fullname: Velez, Juan Carlos – sequence: 9 givenname: Anne-Sophie surname: Grandoulier fullname: Grandoulier, Anne-Sophie – sequence: 10 givenname: Anissa surname: Tse fullname: Tse, Anissa – sequence: 11 givenname: Philippe surname: Picaut fullname: Picaut, Philippe – sequence: 12 givenname: Mauricio R. surname: Delgado fullname: Delgado, Mauricio R. email: Mauricio.Delgado@tsrh.org |
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| Cites_doi | 10.1017/S0012162206001125 10.3390/toxins7051629 10.1111/j.1469-8749.2002.tb00268.x 10.1111/j.1469-8749.2007.00550.x 10.1177/0269215508101742 10.1212/WNL.0b013e3181cbcd2f 10.1016/j.ejpn.2009.09.005 10.1093/ptj/73.10.651 10.1016/j.pmr.2009.04.002 10.1016/j.jval.2012.03.1385 10.1136/bmjopen-2013-002771 10.1007/s11832-013-0511-x 10.1016/j.toxicon.2015.09.020 10.1007/s11832-010-0246-x 10.1542/peds.2015-2830 10.1097/MOP.0000000000000180 10.1136/bmjopen-2012-002230 |
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| Keywords | cerebral palsy abobotulinumtoxinA Dysport equinus foot goal attainment scaling |
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10.1016/j.ejpn.2009.09.005 – ident: bibr16-0883073816686910 doi: 10.1093/ptj/73.10.651 – ident: bibr18-0883073816686910 doi: 10.1016/j.pmr.2009.04.002 – volume: 109 start-page: 8 year: 2007 ident: bibr13-0883073816686910 publication-title: Dev Med Child Neurol Suppl contributor: fullname: Rosenbaum P – ident: bibr8-0883073816686910 doi: 10.1016/j.jval.2012.03.1385 – volume: 3 start-page: e002771 year: 2013 ident: bibr15-0883073816686910 publication-title: BMJ Open doi: 10.1136/bmjopen-2013-002771 contributor: fullname: Turner-Stokes L – ident: bibr9-0883073816686910 doi: 10.1007/s11832-013-0511-x – ident: bibr17-0883073816686910 doi: 10.1016/j.toxicon.2015.09.020 – ident: bibr2-0883073816686910 doi: 10.1007/s11832-010-0246-x – ident: bibr12-0883073816686910 doi: 10.1542/peds.2015-2830 – ident: bibr1-0883073816686910 doi: 10.1097/MOP.0000000000000180 – volume: 3 start-page: e002230 year: 2013 ident: bibr10-0883073816686910 publication-title: BMJ Open doi: 10.1136/bmjopen-2012-002230 contributor: fullname: Turner-Stokes L |
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| SubjectTerms | Adolescent Botulinum Toxins, Type A - pharmacology Botulinum Toxins, Type A - therapeutic use Cerebral Palsy - complications Cerebral Palsy - drug therapy Child Child, Preschool Double-Blind Method Equinus Deformity - drug therapy Equinus Deformity - etiology Female Gait - drug effects Goals Humans Male Neuromuscular Agents - pharmacology Neuromuscular Agents - therapeutic use Original Treatment Outcome |
| Title | AbobotulinumtoxinA (Dysport®) Improves Function According to Goal Attainment in Children With Dynamic Equinus Due to Cerebral Palsy |
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