Dose Response with OnabotulinumtoxinA for Post-Stroke Spasticity: A Pooled Data Analysis
Identifieur interne : 001C13 ( Main/Merge ); précédent : 001C12; suivant : 001C14Dose Response with OnabotulinumtoxinA for Post-Stroke Spasticity: A Pooled Data Analysis
Auteurs : Stuart A. Yablon [États-Unis] ; Mitchell F. Brin [États-Unis] ; Amanda M. Vandenburgh [États-Unis] ; JIHAO ZHOU [États-Unis] ; Susan M. Garabedian-Ruffalo [États-Unis] ; Susan Abu-Shakra [États-Unis] ; Frederick C. Iii Beddingfield [États-Unis]Source :
- Movement disorders [ 0885-3185 ] ; 2011.
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- Pascal (Inist)
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Abstract
Clinical trials demonstrate that onabotulinumtoxinA reduces upper limb post-stroke spasticity, with therapeutic response influenced by injected dose. Individual studies provide limited insight regarding muscle group-specific dose-response relationships. Our objective was to characterize dose-response relationships between onabotulinumtoxinA and muscle tone in specific upper limb muscles. Individual patient data from seven multicenter, randomized, double-blind, placebo-controlled trials were pooled. Of 544 post-stroke patients enrolled, 362 received onabotulinumtoxinA and 182 received placebo, injected into the flexor carpi radialis (FCR), flexor carpi ulnaris (FCU), flexor digitorum superficialis (FDS), flexor digitorum profundus (FDP), and/or biceps brachii (BB). Ashworth Scale score change at week 6 (AshworthCBL) was the primary outcome measure for muscle tone. For a broader analysis of response, AshworthCBL/onabotulinumtoxinA dosage relationships were characterized using three techniques: (1) AshworthCBL plotted as a function of onabotulinumtoxinA dose in Units (U) [dose-response curve]; (2) mean AshworthCBL per onabotulinumtoxinA dose depicting the responses seen with specific dose injection clusters/groups for each specific muscle group; and (3) onabotulinumtoxina dose estimated to produce a mean 1-point decrease in AshworthCBL as an indicator of clinically meaningful benefit of treatment. Increasing onabotulinumtoxinA doses produced greater AshworthCBLs (muscle tone improvements). The maximal week 6 response (Emax) model indicated a saturating dose-response relationship, with mean Emax AshworthCBL values of -1.48, -1.48, -0.63, -0.77, and -0.61 in the FCR, FCU, FDS, FDP, and BB, respectively. OnabotulinumtoxinA doses estimated to produce a mean 1-point decrease in AshworthCBL were: 22.5U, 18.4U, 66.3U, 42.5U in the FCR, FCU, FDS, and FDP, respectively, and not determinable in the BB. These analyses demonstrate a saturating effect of greater muscle tone improvements with increasing onabotulinumtoxinA doses in post-stroke spasticity patients. These findings suggest potentially effective onabotulinumtoxinA doses in selected muscle groups in this study population.
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Yablon</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Baylor Institute for Rehabilitation</s1><s2>Dallas, Texas</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F." last="Brin">Mitchell F. 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Garabedian-Ruffalo</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>University of Southern California, School of Pharmacy</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region><settlement type="city">Los Angeles</settlement></placeName><orgName type="university">Université de Californie du Sud</orgName></affiliation></author><author><name sortKey="Abu Shakra, Susan" sort="Abu Shakra, Susan" uniqKey="Abu Shakra S" first="Susan" last="Abu-Shakra">Susan Abu-Shakra</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Global Clinical Development, Allergan</s1><s2>Irvine, California</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Beddingfield, Frederick C Iii" sort="Beddingfield, Frederick C Iii" uniqKey="Beddingfield F" first="Frederick C. Iii" last="Beddingfield">Frederick C. Iii Beddingfield</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Global Clinical Development, Allergan</s1><s2>Irvine, California</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Department of Medicine, David Geffen School of Medicine at UCLA</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Data analysis</term><term>Nervous system diseases</term><term>Spasticity</term><term>Stroke</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Accident cérébrovasculaire</term><term>Hypertonie spastique</term><term>Pathologie du système nerveux</term><term>Analyse donnée</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Clinical trials demonstrate that onabotulinumtoxinA reduces upper limb post-stroke spasticity, with therapeutic response influenced by injected dose. Individual studies provide limited insight regarding muscle group-specific dose-response relationships. Our objective was to characterize dose-response relationships between onabotulinumtoxinA and muscle tone in specific upper limb muscles. Individual patient data from seven multicenter, randomized, double-blind, placebo-controlled trials were pooled. Of 544 post-stroke patients enrolled, 362 received onabotulinumtoxinA and 182 received placebo, injected into the flexor carpi radialis (FCR), flexor carpi ulnaris (FCU), flexor digitorum superficialis (FDS), flexor digitorum profundus (FDP), and/or biceps brachii (BB). Ashworth Scale score change at week 6 (AshworthCBL) was the primary outcome measure for muscle tone. For a broader analysis of response, AshworthCBL/onabotulinumtoxinA dosage relationships were characterized using three techniques: (1) AshworthCBL plotted as a function of onabotulinumtoxinA dose in Units (U) [dose-response curve]; (2) mean AshworthCBL per onabotulinumtoxinA dose depicting the responses seen with specific dose injection clusters/groups for each specific muscle group; and (3) onabotulinumtoxina dose estimated to produce a mean 1-point decrease in AshworthCBL as an indicator of clinically meaningful benefit of treatment. Increasing onabotulinumtoxinA doses produced greater AshworthCBLs (muscle tone improvements). The maximal week 6 response (E<sub>max</sub>) model indicated a saturating dose-response relationship, with mean E<sub>max</sub> AshworthCBL values of -1.48, -1.48, -0.63, -0.77, and -0.61 in the FCR, FCU, FDS, FDP, and BB, respectively. OnabotulinumtoxinA doses estimated to produce a mean 1-point decrease in AshworthCBL were: 22.5U, 18.4U, 66.3U, 42.5U in the FCR, FCU, FDS, and FDP, respectively, and not determinable in the BB. These analyses demonstrate a saturating effect of greater muscle tone improvements with increasing onabotulinumtoxinA doses in post-stroke spasticity patients. These findings suggest potentially effective onabotulinumtoxinA doses in selected muscle groups in this study population.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Californie</li><li>Texas</li></region><settlement><li>Los Angeles</li></settlement><orgName><li>Université de Californie du Sud</li></orgName></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Yablon, Stuart A" sort="Yablon, Stuart A" uniqKey="Yablon S" first="Stuart A." last="Yablon">Stuart A. Yablon</name></region><name sortKey="Abu Shakra, Susan" sort="Abu Shakra, Susan" uniqKey="Abu Shakra S" first="Susan" last="Abu-Shakra">Susan Abu-Shakra</name><name sortKey="Beddingfield, Frederick C Iii" sort="Beddingfield, Frederick C Iii" uniqKey="Beddingfield F" first="Frederick C. Iii" last="Beddingfield">Frederick C. Iii Beddingfield</name><name sortKey="Beddingfield, Frederick C Iii" sort="Beddingfield, Frederick C Iii" uniqKey="Beddingfield F" first="Frederick C. Iii" last="Beddingfield">Frederick C. Iii Beddingfield</name><name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F." last="Brin">Mitchell F. Brin</name><name sortKey="Brin, Mitchell F" sort="Brin, Mitchell F" uniqKey="Brin M" first="Mitchell F." last="Brin">Mitchell F. Brin</name><name sortKey="Garabedian Ruffalo, Susan M" sort="Garabedian Ruffalo, Susan M" uniqKey="Garabedian Ruffalo S" first="Susan M." last="Garabedian-Ruffalo">Susan M. Garabedian-Ruffalo</name><name sortKey="Jihao Zhou" sort="Jihao Zhou" uniqKey="Jihao Zhou" last="Jihao Zhou">JIHAO ZHOU</name><name sortKey="Vandenburgh, Amanda M" sort="Vandenburgh, Amanda M" uniqKey="Vandenburgh A" first="Amanda M." last="Vandenburgh">Amanda M. Vandenburgh</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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