BotB (botulinum Toxin type B): Evaluation of safety and tolerability in botulinum toxin type A‐Resistant cervical dystonia patients (preliminary study)
Identifieur interne : 005397 ( Main/Exploration ); précédent : 005396; suivant : 005398BotB (botulinum Toxin type B): Evaluation of safety and tolerability in botulinum toxin type A‐Resistant cervical dystonia patients (preliminary study)
Auteurs : Truong [États-Unis] ; Paul A. Cullis [États-Unis] ; Christopher F. O'Brien [États-Unis] ; Martin Koller [États-Unis] ; Timothy P. Villegas [États-Unis] ; Jan D. Wallace [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 1997-09.
English descriptors
- KwdEn :
- Adult, Aged, Anti-Dyskinesia Agents (adverse effects), Anti-Dyskinesia Agents (immunology), Anti-Dyskinesia Agents (therapeutic use), BotB, Botulinum Toxins (adverse effects), Botulinum Toxins (immunology), Botulinum Toxins (therapeutic use), Botulinum Toxins, Type A (therapeutic use), Botulinum toxin type B, Cervical dystonia, Clinical trial, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Evaluation, Drug Resistance, Dystonia (drug therapy), Female, Humans, Injections, Intramuscular, Male, Middle Aged, Pain Measurement, Pilot Projects, Prospective Studies, Severity of Illness Index, Torticollis (drug therapy), Treatment Outcome, Type‐A resistance.
- MESH :
- chemical , adverse effects : Anti-Dyskinesia Agents, Botulinum Toxins.
- chemical , immunology : Anti-Dyskinesia Agents, Botulinum Toxins.
- chemical , therapeutic use : Anti-Dyskinesia Agents, Botulinum Toxins, Botulinum Toxins, Type A.
- drug therapy : Dystonia, Torticollis.
- Adult, Aged, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Evaluation, Drug Resistance, Female, Humans, Injections, Intramuscular, Male, Middle Aged, Pain Measurement, Pilot Projects, Prospective Studies, Severity of Illness Index, Treatment Outcome.
Abstract
Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open‐label, dose‐escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose‐limiting toxicity in this patient population. Mild‐to‐moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type‐B treatment were reported. Low‐dosing‐session (100‐‐899 units) and high‐dosing‐session (900–1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale‐Severity Scale (TWSTRS‐Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS‐Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low‐dose and high‐dose groups, respectively. Effectiveness was noted for the high‐dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.
Url:
DOI: 10.1002/mds.870120526
Affiliations:
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Villegas</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Athena Neurosciences, South San Francisco, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Wallace, Jan D" sort="Wallace, Jan D" uniqKey="Wallace J" first="Jan D." last="Wallace">Jan D. Wallace</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Athena Neurosciences, South San Francisco, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</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="1997-09">1997-09</date><biblScope unit="vol">12</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="772">772</biblScope><biblScope unit="page" to="775">775</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">2D9091E7A6876B2DC33FD673B877E5D6B34A2B46</idno><idno type="DOI">10.1002/mds.870120526</idno><idno type="ArticleID">MDS870120526</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Anti-Dyskinesia Agents (adverse effects)</term><term>Anti-Dyskinesia Agents (immunology)</term><term>Anti-Dyskinesia Agents (therapeutic use)</term><term>BotB</term><term>Botulinum Toxins (adverse effects)</term><term>Botulinum Toxins (immunology)</term><term>Botulinum Toxins (therapeutic use)</term><term>Botulinum Toxins, Type A (therapeutic use)</term><term>Botulinum toxin type B</term><term>Cervical dystonia</term><term>Clinical trial</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Drug Evaluation</term><term>Drug Resistance</term><term>Dystonia (drug therapy)</term><term>Female</term><term>Humans</term><term>Injections, Intramuscular</term><term>Male</term><term>Middle Aged</term><term>Pain Measurement</term><term>Pilot Projects</term><term>Prospective Studies</term><term>Severity of Illness Index</term><term>Torticollis (drug therapy)</term><term>Treatment Outcome</term><term>Type‐A resistance</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anti-Dyskinesia Agents</term><term>Botulinum Toxins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Anti-Dyskinesia Agents</term><term>Botulinum Toxins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Dyskinesia Agents</term><term>Botulinum Toxins</term><term>Botulinum Toxins, Type A</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Dystonia</term><term>Torticollis</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Drug Evaluation</term><term>Drug Resistance</term><term>Female</term><term>Humans</term><term>Injections, Intramuscular</term><term>Male</term><term>Middle Aged</term><term>Pain Measurement</term><term>Pilot Projects</term><term>Prospective Studies</term><term>Severity of Illness Index</term><term>Treatment Outcome</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open‐label, dose‐escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose‐limiting toxicity in this patient population. Mild‐to‐moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type‐B treatment were reported. Low‐dosing‐session (100‐‐899 units) and high‐dosing‐session (900–1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale‐Severity Scale (TWSTRS‐Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS‐Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low‐dose and high‐dose groups, respectively. Effectiveness was noted for the high‐dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Californie</li><li>Colorado</li><li>Michigan</li></region></list><tree><country name="États-Unis"><region name="Californie"><name sortKey="Truong" sort="Truong" uniqKey="Truong" last="Truong">Truong</name></region><name sortKey="Cullis, Paul A" sort="Cullis, Paul A" uniqKey="Cullis P" first="Paul A." last="Cullis">Paul A. Cullis</name><name sortKey="Koller, Martin" sort="Koller, Martin" uniqKey="Koller M" first="Martin" last="Koller">Martin Koller</name><name sortKey="O Brien, Christopher F" sort="O Brien, Christopher F" uniqKey="O Brien C" first="Christopher F." last="O'Brien">Christopher F. O'Brien</name><name sortKey="Villegas, Timothy P" sort="Villegas, Timothy P" uniqKey="Villegas T" first="Timothy P." last="Villegas">Timothy P. Villegas</name><name sortKey="Wallace, Jan D" sort="Wallace, Jan D" uniqKey="Wallace J" first="Jan D." last="Wallace">Jan D. Wallace</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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