Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm—A randomized trial
Identifieur interne : 001682 ( Main/Exploration ); précédent : 001681; suivant : 001683Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm—A randomized trial
Auteurs : Joseph Jankovic [États-Unis] ; Cynthia Comella [États-Unis] ; Angelika Hanschmann [Allemagne] ; Susanne Grafe [Allemagne]Source :
- Movement Disorders [ 0885-3185 ] ; 2011-07.
Descripteurs français
- Pascal (Inist)
- Wicri :
- geographic : Canada, États-Unis.
English descriptors
- KwdEn :
- Aged, Blepharoptosis (chemically induced), Blepharospasm, Blepharospasm (drug therapy), Blepharospasm (immunology), Bontoxilysin, Botulinum Toxins, Type A (therapeutic use), Canada, Disability Evaluation, Double-Blind Method, Dystonia, Electrocardiography, Enzyme-Linked Immunosorbent Assay, Female, Follow-Up Studies, Humans, Male, Middle Aged, Nervous system diseases, Neuromuscular Agents (therapeutic use), Safety, Severity of Illness Index, Time Factors, Treatment, Treatment Outcome, United States, Xerostomia (chemically induced), blepharospasm, botulinum toxin, dystonia, incobotulinumtoxinA.
- MESH :
- chemical , therapeutic use : Botulinum Toxins, Type A, Neuromuscular Agents.
- geographic : Canada, United States.
- chemically induced : Blepharoptosis, Xerostomia.
- drug therapy : Blepharospasm.
- immunology : Blepharospasm.
- Aged, Disability Evaluation, Double-Blind Method, Electrocardiography, Enzyme-Linked Immunosorbent Assay, Female, Follow-Up Studies, Humans, Male, Middle Aged, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
IncobotulinumtoxinA (NT 201, Xeomin) is a highly purified botulinum neurotoxin type A formulation, free from complexing proteins. A randomized, placebo‐controlled, double‐blind trial of efficacy and safety compared incobotulinumtoxinA (up to 50 U per eye) to placebo administered in a single treatment session to patients with blepharospasm. All patients had documented satisfactory response to 2 previous treatments with botulinum neurotoxin type A other than incobotulinumtoxinA and had Jankovic Rating Scale severity subscores ≥ 2. Patients (n = 109) were randomized in a 2:1 ratio to incobotulinumtoxinA or placebo and followed up to 20 weeks; 94% completed the study. A significant difference was observed in the primary efficacy variable (change in Jankovic Rating Scale severity subscore rated by an independent rater 6 weeks following treatment), favoring incobotulinumtoxinA by 1.0 point (95% CI [0.5–1.4]; P < .001). Functional impairment, as measured by the Blepharospasm Disability Index, improved by 0.5 points (95% CI [0.2–0.7]; P = .002) compared with placebo. There was a strong correlation between the 2 scale scores. In addition, all secondary outcome measures favored incobotulinumtoxinA. Patients rated the mean therapeutic effect of incobotulinumtoxinA significantly better than placebo (P < .001). Adverse events were reported in 70.3% of incobotulinumtoxinA patients and 58.8% of placebo patients. Eyelid ptosis (18.9% vs 5.9%), dry eye (18.9% vs 11.8%), and dry mouth (14.9% vs 2.9%) occurred most frequently. Tolerability was rated good/very good by 91.9% of incobotulinumtoxinA versus in 85.2% of placebo patients. In conclusion, incobotulinumtoxinA was well tolerated and was associated with statistically significant and clinically relevant reductions in blepharospasm severity and functional impairment. © 2011 Movement Disorder Society
Url:
DOI: 10.1002/mds.23658
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 000530
- to stream Istex, to step Curation: 000530
- to stream Istex, to step Checkpoint: 000415
- to stream PubMed, to step Corpus: 001249
- to stream PubMed, to step Curation: 001249
- to stream PubMed, to step Checkpoint: 001358
- to stream Ncbi, to step Merge: 003178
- to stream Ncbi, to step Curation: 003178
- to stream Ncbi, to step Checkpoint: 003178
- to stream Main, to step Merge: 001736
- to stream PascalFrancis, to step Corpus: 000509
- to stream PascalFrancis, to step Curation: 002809
- to stream PascalFrancis, to step Checkpoint: 000618
- to stream Main, to step Merge: 001C08
- to stream Main, to step Curation: 001682
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm—A randomized trial</title><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation><country>États-Unis</country><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="Comella, Cynthia" sort="Comella, Cynthia" uniqKey="Comella C" first="Cynthia" last="Comella">Cynthia Comella</name></author><author><name sortKey="Hanschmann, Angelika" sort="Hanschmann, Angelika" uniqKey="Hanschmann A" first="Angelika" last="Hanschmann">Angelika Hanschmann</name></author><author><name sortKey="Grafe, Susanne" sort="Grafe, Susanne" uniqKey="Grafe S" first="Susanne" last="Grafe">Susanne Grafe</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:2C5B1B5CB1B0FA44635E363B59BE0B575FD5A56E</idno><date when="2011" year="2011">2011</date><idno type="doi">10.1002/mds.23658</idno><idno type="url">https://api.istex.fr/document/2C5B1B5CB1B0FA44635E363B59BE0B575FD5A56E/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000530</idno><idno type="wicri:Area/Istex/Curation">000530</idno><idno type="wicri:Area/Istex/Checkpoint">000415</idno><idno type="wicri:doubleKey">0885-3185:2011:Jankovic J:efficacy:and:safety</idno><idno type="wicri:source">PubMed</idno><idno type="RBID">pubmed:21520284</idno><idno type="wicri:Area/PubMed/Corpus">001249</idno><idno type="wicri:Area/PubMed/Curation">001249</idno><idno type="wicri:Area/PubMed/Checkpoint">001358</idno><idno type="wicri:Area/Ncbi/Merge">003178</idno><idno type="wicri:Area/Ncbi/Curation">003178</idno><idno type="wicri:Area/Ncbi/Checkpoint">003178</idno><idno type="wicri:Area/Main/Merge">001736</idno><idno type="wicri:source">INIST</idno><idno type="RBID">Pascal:11-0353399</idno><idno type="wicri:Area/PascalFrancis/Corpus">000509</idno><idno type="wicri:Area/PascalFrancis/Curation">002809</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000618</idno><idno type="wicri:doubleKey">0885-3185:2011:Jankovic J:efficacy:and:safety</idno><idno type="wicri:Area/Main/Merge">001C08</idno><idno type="wicri:Area/Main/Curation">001682</idno><idno type="wicri:Area/Main/Exploration">001682</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm—A randomized trial</title><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Baylor College of Medicine, Houston, Texas</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="Comella, Cynthia" sort="Comella, Cynthia" uniqKey="Comella C" first="Cynthia" last="Comella">Cynthia Comella</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Rush University, Chicago, Illinois</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Hanschmann, Angelika" sort="Hanschmann, Angelika" uniqKey="Hanschmann A" first="Angelika" last="Hanschmann">Angelika Hanschmann</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Merz Pharmaceuticals GmbH, Frankfurt/Main</wicri:regionArea><wicri:noRegion>Frankfurt/Main</wicri:noRegion><wicri:noRegion>Frankfurt/Main</wicri:noRegion></affiliation></author><author><name sortKey="Grafe, Susanne" sort="Grafe, Susanne" uniqKey="Grafe S" first="Susanne" last="Grafe">Susanne Grafe</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Merz Pharmaceuticals GmbH, Frankfurt/Main</wicri:regionArea><wicri:noRegion>Frankfurt/Main</wicri:noRegion><wicri:noRegion>Frankfurt/Main</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2011-07">2011-07</date><biblScope unit="vol">26</biblScope><biblScope unit="issue">8</biblScope><biblScope unit="page" from="1521">1521</biblScope><biblScope unit="page" to="1528">1528</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">2C5B1B5CB1B0FA44635E363B59BE0B575FD5A56E</idno><idno type="DOI">10.1002/mds.23658</idno><idno type="ArticleID">MDS23658</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Blepharoptosis (chemically induced)</term><term>Blepharospasm</term><term>Blepharospasm (drug therapy)</term><term>Blepharospasm (immunology)</term><term>Bontoxilysin</term><term>Botulinum Toxins, Type A (therapeutic use)</term><term>Canada</term><term>Disability Evaluation</term><term>Double-Blind Method</term><term>Dystonia</term><term>Electrocardiography</term><term>Enzyme-Linked Immunosorbent Assay</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Neuromuscular Agents (therapeutic use)</term><term>Safety</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment</term><term>Treatment Outcome</term><term>United States</term><term>Xerostomia (chemically induced)</term><term>blepharospasm</term><term>botulinum toxin</term><term>dystonia</term><term>incobotulinumtoxinA</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Botulinum Toxins, Type A</term><term>Neuromuscular Agents</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Canada</term><term>United States</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Blepharoptosis</term><term>Xerostomia</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Blepharospasm</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Blepharospasm</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Disability Evaluation</term><term>Double-Blind Method</term><term>Electrocardiography</term><term>Enzyme-Linked Immunosorbent Assay</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Blépharospasme</term><term>Bontoxilysin</term><term>Dystonie</term><term>Pathologie du système nerveux</term><term>Sécurité</term><term>Traitement</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Canada</term><term>États-Unis</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">IncobotulinumtoxinA (NT 201, Xeomin) is a highly purified botulinum neurotoxin type A formulation, free from complexing proteins. A randomized, placebo‐controlled, double‐blind trial of efficacy and safety compared incobotulinumtoxinA (up to 50 U per eye) to placebo administered in a single treatment session to patients with blepharospasm. All patients had documented satisfactory response to 2 previous treatments with botulinum neurotoxin type A other than incobotulinumtoxinA and had Jankovic Rating Scale severity subscores ≥ 2. Patients (n = 109) were randomized in a 2:1 ratio to incobotulinumtoxinA or placebo and followed up to 20 weeks; 94% completed the study. A significant difference was observed in the primary efficacy variable (change in Jankovic Rating Scale severity subscore rated by an independent rater 6 weeks following treatment), favoring incobotulinumtoxinA by 1.0 point (95% CI [0.5–1.4]; P < .001). Functional impairment, as measured by the Blepharospasm Disability Index, improved by 0.5 points (95% CI [0.2–0.7]; P = .002) compared with placebo. There was a strong correlation between the 2 scale scores. In addition, all secondary outcome measures favored incobotulinumtoxinA. Patients rated the mean therapeutic effect of incobotulinumtoxinA significantly better than placebo (P < .001). Adverse events were reported in 70.3% of incobotulinumtoxinA patients and 58.8% of placebo patients. Eyelid ptosis (18.9% vs 5.9%), dry eye (18.9% vs 11.8%), and dry mouth (14.9% vs 2.9%) occurred most frequently. Tolerability was rated good/very good by 91.9% of incobotulinumtoxinA versus in 85.2% of placebo patients. In conclusion, incobotulinumtoxinA was well tolerated and was associated with statistically significant and clinically relevant reductions in blepharospasm severity and functional impairment. © 2011 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>États-Unis</li></country><region><li>Illinois</li><li>Texas</li></region><settlement><li>Houston</li></settlement><orgName><li>Baylor College of Medicine</li></orgName></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name></region><name sortKey="Comella, Cynthia" sort="Comella, Cynthia" uniqKey="Comella C" first="Cynthia" last="Comella">Cynthia Comella</name></country><country name="Allemagne"><noRegion><name sortKey="Hanschmann, Angelika" sort="Hanschmann, Angelika" uniqKey="Hanschmann A" first="Angelika" last="Hanschmann">Angelika Hanschmann</name></noRegion><name sortKey="Grafe, Susanne" sort="Grafe, Susanne" uniqKey="Grafe S" first="Susanne" last="Grafe">Susanne Grafe</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001682 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001682 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= MovDisordV3
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:2C5B1B5CB1B0FA44635E363B59BE0B575FD5A56E
|texte= Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm—A randomized trial
}}
| This area was generated with Dilib version V0.6.23. |  |