Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): Interim Results for the First 170 Subjects with Blepharospasm
Identifieur interne : 000463 ( Ncbi/Checkpoint ); précédent : 000462; suivant : 000464Observational 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
Affiliations:
- États-Unis
- Caroline du Nord, Géorgie (États-Unis), Michigan, Missouri (État), Ohio, Texas
- Houston
- Baylor College of Medicine
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PMC:4107228Le document en format XML
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<series><title level="j">Tremor and Other Hyperkinetic Movements</title>
<idno type="e-ISSN">2160-8288</idno>
<imprint><date when="2014">2014</date>
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<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>
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