Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm
Identifieur interne : 000067 ( Main/Curation ); précédent : 000066; suivant : 000068Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm
Auteurs : Hubert Fernandez [États-Unis] ; Joseph Jankovic [États-Unis] ; John Holds [États-Unis] ; Daniel Lin [États-Unis] ; John Burns [États-Unis] ; Amit Verma [États-Unis] ; Kapil Sethi [États-Unis] ; Eric Pappert [États-Unis]Source :
- Tremor and Other Hyperkinetic Movements ; 2014.
Abstract
XCiDaBLE is a large, prospective, observational “naturalistic” study evaluating
Subjects (≥18 years old) with blepharospasm were followed for two treatment cycles of incobotulinumtoxinA and monitored for 4 weeks after injection via interactive voice/web response system (IVRS/IWRS). The investigator-reported scale includes the Clinical Global Impression Scale-Severity subscale (CGI-S). Patient-reported outcome measures include the Patient Global Impression Scale-Severity (PGI-S) and -Improvement (PGI-I) subscales, Jankovic Rating Scale (JRS), SF-12v2® health survey, and Work Productivity and Activity Impairment questionnaire. Subjects are seen by the investigator at baseline (including the first injection), during the second injection, and at a final study visit (12 weeks after the second injection).
One hundred seventy subjects were included in this interim analysis. The majority of subjects were female (77.1%) and white (91.8%), and had previously been treated with botulinum toxins (96.5%). The mean total dose (both eyes) was 71.5 U of incobotulinumtoxinA for the first injection. PGI-S, PGI-I, and JRS scores were significantly improved 4 weeks after treatment (all p<0.0001). No differences were noted in either quality of life (QoL) or work productivity in this short assessment period. No unexpected adverse events occurred.
This is an interim study and assessment method based on an IVRS/IWRS. In this predominantly toxin-experienced cohort, significant benefits in specific and global measures of disease severity were seen in the immediate post-incobotulinumtoxinA injection period. It will be interesting to see if there are improvements in QoL with consistent individualized injections over a longer period.
Url:
DOI: 10.7916/D8MK6B1B
PubMed: 25120942
PubMed Central: 4107228
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GA</wicri:regionArea><placeName><region type="state">Géorgie (États-Unis)</region></placeName></affiliation></author><author><name sortKey="Pappert, Eric J" sort="Pappert, Eric J" uniqKey="Pappert E" first="Eric" last="Pappert">Eric Pappert</name><affiliation wicri:level="2"><nlm:aff id="aff8"><addr-line>Merz Pharmaceuticals, LLC, Greensboro, NC, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merz Pharmaceuticals, LLC, Greensboro, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25120942</idno><idno type="pmc">4107228</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107228</idno><idno type="RBID">PMC:4107228</idno><idno type="doi">10.7916/D8MK6B1B</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000299</idno><idno type="wicri:Area/Pmc/Curation">000299</idno><idno 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type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="2"><nlm:aff id="aff2"><addr-line>Baylor College of Medicine, Houston, TX, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Baylor College of Medicine, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author><author><name sortKey="Holds, John B" sort="Holds, John B" uniqKey="Holds J" first="John" last="Holds">John Holds</name><affiliation wicri:level="2"><nlm:aff id="aff3"><addr-line>Ophthalmic Plastic and Cosmetic Surgery, Inc., Des Peres, MO, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Ophthalmic Plastic and Cosmetic Surgery, Inc., Des Peres, MO</wicri:regionArea><placeName><region type="state">Missouri (État)</region></placeName></affiliation></author><author><name sortKey="Lin, Daniel" sort="Lin, Daniel" uniqKey="Lin D" first="Daniel" last="Lin">Daniel Lin</name><affiliation wicri:level="2"><nlm:aff id="aff4"><addr-line>Michigan Neuro-ophthalmology & Oculoplastics, PLC, Warren, MI, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Michigan Neuro-ophthalmology & Oculoplastics, PLC, Warren, MI</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Burns, John" sort="Burns, John" uniqKey="Burns J" first="John" last="Burns">John Burns</name><affiliation wicri:level="2"><nlm:aff id="aff5"><addr-line>Ophthalmic Surgeons and Consultants of Ohio, Columbus, OH, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Ophthalmic Surgeons and Consultants of Ohio, Columbus, OH</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Verma, Amit" sort="Verma, Amit" uniqKey="Verma A" first="Amit" last="Verma">Amit Verma</name><affiliation wicri:level="2"><nlm:aff id="aff6"><addr-line>Merz North America, Inc., Greensboro, NC, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merz North America, Inc., Greensboro, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Sethi, Kapil" sort="Sethi, Kapil" uniqKey="Sethi K" first="Kapil" last="Sethi">Kapil Sethi</name><affiliation wicri:level="2"><nlm:aff id="aff6"><addr-line>Merz North America, Inc., Greensboro, NC, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merz North America, Inc., Greensboro, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation><affiliation wicri:level="2"><nlm:aff id="aff7"><addr-line>Georgia Health Sciences University, Atlanta, GA, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Georgia Health Sciences University, Atlanta, GA</wicri:regionArea><placeName><region type="state">Géorgie (États-Unis)</region></placeName></affiliation></author><author><name sortKey="Pappert, Eric J" sort="Pappert, Eric J" uniqKey="Pappert E" first="Eric" last="Pappert">Eric Pappert</name><affiliation wicri:level="2"><nlm:aff id="aff8"><addr-line>Merz Pharmaceuticals, LLC, Greensboro, NC, USA</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Merz Pharmaceuticals, LLC, Greensboro, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author></analytic><series><title level="j">Tremor and Other Hyperkinetic Movements</title><idno type="e-ISSN">2160-8288</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>XCiDaBLE is a large, prospective, observational “naturalistic” study evaluating <bold>X</bold>eomin® for <bold>C</bold>erv<bold>i</bold>cal <bold>D</bold>ystoni<bold>a</bold> or <bold>BLE</bold>pharospasm in the United States. We report the interim results from the blepharospasm cohort of XCiDaBLE.</p></sec><sec><title>Methods</title><p>Subjects (≥18 years old) with blepharospasm were followed for two treatment cycles of incobotulinumtoxinA and monitored for 4 weeks after injection via interactive voice/web response system (IVRS/IWRS). The investigator-reported scale includes the Clinical Global Impression Scale-Severity subscale (CGI-S). Patient-reported outcome measures include the Patient Global Impression Scale-Severity (PGI-S) and -Improvement (PGI-I) subscales, Jankovic Rating Scale (JRS), SF-12v2® health survey, and Work Productivity and Activity Impairment questionnaire. Subjects are seen by the investigator at baseline (including the first injection), during the second injection, and at a final study visit (12 weeks after the second injection).</p></sec><sec><title>Results</title><p>One hundred seventy subjects were included in this interim analysis. The majority of subjects were female (77.1%) and white (91.8%), and had previously been treated with botulinum toxins (96.5%). The mean total dose (both eyes) was 71.5 U of incobotulinumtoxinA for the first injection. PGI-S, PGI-I, and JRS scores were significantly improved 4 weeks after treatment (all p<0.0001). No differences were noted in either quality of life (QoL) or work productivity in this short assessment period. No unexpected adverse events occurred.</p></sec><sec><title>Discussion</title><p>This is an interim study and assessment method based on an IVRS/IWRS. In this predominantly toxin-experienced cohort, significant benefits in specific and global measures of disease severity were seen in the immediate post-incobotulinumtoxinA injection period. It will be interesting to see if there are improvements in QoL with consistent individualized injections over a longer period.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Tsui, Jk" uniqKey="Tsui J">JK Tsui</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Mccann, Jd" uniqKey="Mccann J">JD McCann</name></author><author><name sortKey="Saulny, S" uniqKey="Saulny S">S Saulny</name></author><author><name sortKey="Golberg, Ra" uniqKey="Golberg R">RA Golberg</name></author><author><name sortKey="Andersen, Rl" uniqKey="Andersen R">RL Andersen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tarsy, D" uniqKey="Tarsy D">D Tarsy</name></author><author><name sortKey="Simon, Dk" uniqKey="Simon D">DK Simon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Simpson, Dm" uniqKey="Simpson D">DM Simpson</name></author><author><name sortKey="Blitzer, A" uniqKey="Blitzer A">A Blitzer</name></author><author><name sortKey="Brashear, A" uniqKey="Brashear A">A Brashear</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jankovic, J" uniqKey="Jankovic J">J Jankovic</name></author><author><name sortKey="Comella, C" uniqKey="Comella C">C Comella</name></author><author><name sortKey="Hanschmann, A" uniqKey="Hanschmann A">A Hanschmann</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wabbels, B" uniqKey="Wabbels B">B Wabbels</name></author><author><name sortKey="Reichel, G" uniqKey="Reichel G">G Reichel</name></author><author><name sortKey="Fulford Smith, A" uniqKey="Fulford Smith A">A Fulford-Smith</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Truong, Dd" uniqKey="Truong D">DD Truong</name></author><author><name sortKey="Gollomp, Sm" uniqKey="Gollomp S">SM Gollomp</name></author><author><name sortKey="Jankovic, J" uniqKey="Jankovic J">J Jankovic</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Colosimo, C" uniqKey="Colosimo C">C Colosimo</name></author><author><name sortKey="Tiple, D" uniqKey="Tiple D">D Tiple</name></author><author><name sortKey="Berardelli, A" uniqKey="Berardelli A">A Berardelli</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Barash, Jr" uniqKey="Barash J">JR Barash</name></author><author><name sortKey="Arnon, Ss" uniqKey="Arnon S">SS Arnon</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Roggenkamper, P" uniqKey="Roggenkamper P">P Roggenkamper</name></author><author><name sortKey="Jost, Wh" uniqKey="Jost W">WH Jost</name></author><author><name sortKey="Bihari, K" uniqKey="Bihari K">K Bihari</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Fernandez, Hh" uniqKey="Fernandez H">HH Fernandez</name></author><author><name sortKey="Pagan, F" uniqKey="Pagan F">F Pagan</name></author><author><name sortKey="Danisi, F" uniqKey="Danisi F">F Danisi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jankovic, J" uniqKey="Jankovic J">J Jankovic</name></author><author><name sortKey="Kenney, C" uniqKey="Kenney C">C Kenney</name></author><author><name sortKey="Grafe, S" uniqKey="Grafe S">S Grafe</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Reilly, Mc" uniqKey="Reilly M">MC Reilly</name></author><author><name sortKey="Zbrozek, As" uniqKey="Zbrozek A">AS Zbrozek</name></author><author><name sortKey="Dukes, Em" uniqKey="Dukes E">EM Dukes</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Pagan, Fl" uniqKey="Pagan F">FL Pagan</name></author><author><name sortKey="Harrison, A" uniqKey="Harrison A">A Harrison</name></author></analytic></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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