Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin versus Toxin-Naïve Subjects with Cervical Dystonia
<p><strong>Background:</strong> To determine whether botulinum toxin treatment history affected the outcomes of a study comparing the safety and efficacy of incobotulinumtoxinA with placebo in subjects with cervical dystonia (CD).</p><p><strong>Methods: </stron...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Ubiquity Press
2013-05-01
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| Series: | Tremor and Other Hyperkinetic Movements |
| Online Access: | https://tremorjournal.org/index.php/tremor/article/view/140 |
| _version_ | 1818862443415207936 |
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| author | Hubert Fernandez Eric J. Pappert Cynthia Comella Virgilio Evidente Daniel Truong Amit Verma Joseph Jankovic |
| author_facet | Hubert Fernandez Eric J. Pappert Cynthia Comella Virgilio Evidente Daniel Truong Amit Verma Joseph Jankovic |
| author_sort | Hubert Fernandez |
| collection | DOAJ |
| description | <p><strong>Background:</strong> To determine whether botulinum toxin treatment history affected the outcomes of a study comparing the safety and efficacy of incobotulinumtoxinA with placebo in subjects with cervical dystonia (CD).</p><p><strong>Methods: </strong>This was a prospective, double‐blind, randomized, placebo‐controlled, multicenter trial in botulinum toxin‐treated or toxin‐naïve CD subjects. Subjects received a fixed dose of either 120 U or 240 U of incobotulinumtoxinA or placebo. The primary outcome measure was change from baseline to Week 4 in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score. Treatment‐emergent adverse events (TEAEs) were also evaluated. This report represents a subgroup analysis of botulinum toxin‐treated or toxin‐naïve subjects.</p><p><strong>Results:</strong> Participants (N = 233; 38.6% toxin‐naïve) had a mean age of 52.8 years. IncobotulinumtoxinA significantly improved TWSTRS total scores from baseline to Week 4 in both dose groups versus placebo, and the improvement persisted through the end of the study (≤20 weeks). Both the previously toxin‐treated and toxin‐naïve subjects demonstrated significant improvements in TWSTRS total scores at Week 4 compared to baseline. The most frequent TEAEs in the incobotulinumtoxinA groups were dysphagia, neck pain, and muscular weakness, which were generally mild. TEAEs were more common in the 240 U group and toxin‐naïve subjects. <strong>Discussion:</strong> Overall, incobotulinumtoxinA was safe and effective in CD, regardless of toxin therapy history. A lower starting dose may be better tolerated among toxin‐naïve subjects without sacrificing efficacy.</p> |
| first_indexed | 2024-12-19T09:59:57Z |
| format | Article |
| id | doaj.art-0866985a4ada497e8e2963b25559b76b |
| institution | Directory Open Access Journal |
| issn | 2160-8288 |
| language | English |
| last_indexed | 2024-12-19T09:59:57Z |
| publishDate | 2013-05-01 |
| publisher | Ubiquity Press |
| record_format | Article |
| series | Tremor and Other Hyperkinetic Movements |
| spelling | doaj.art-0866985a4ada497e8e2963b25559b76b2022-12-21T20:26:40ZengUbiquity PressTremor and Other Hyperkinetic Movements2160-82882013-05-01310.7916/D87P8X4389Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin versus Toxin-Naïve Subjects with Cervical DystoniaHubert FernandezEric J. PappertCynthia ComellaVirgilio EvidenteDaniel TruongAmit VermaJoseph Jankovic<p><strong>Background:</strong> To determine whether botulinum toxin treatment history affected the outcomes of a study comparing the safety and efficacy of incobotulinumtoxinA with placebo in subjects with cervical dystonia (CD).</p><p><strong>Methods: </strong>This was a prospective, double‐blind, randomized, placebo‐controlled, multicenter trial in botulinum toxin‐treated or toxin‐naïve CD subjects. Subjects received a fixed dose of either 120 U or 240 U of incobotulinumtoxinA or placebo. The primary outcome measure was change from baseline to Week 4 in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score. Treatment‐emergent adverse events (TEAEs) were also evaluated. This report represents a subgroup analysis of botulinum toxin‐treated or toxin‐naïve subjects.</p><p><strong>Results:</strong> Participants (N = 233; 38.6% toxin‐naïve) had a mean age of 52.8 years. IncobotulinumtoxinA significantly improved TWSTRS total scores from baseline to Week 4 in both dose groups versus placebo, and the improvement persisted through the end of the study (≤20 weeks). Both the previously toxin‐treated and toxin‐naïve subjects demonstrated significant improvements in TWSTRS total scores at Week 4 compared to baseline. The most frequent TEAEs in the incobotulinumtoxinA groups were dysphagia, neck pain, and muscular weakness, which were generally mild. TEAEs were more common in the 240 U group and toxin‐naïve subjects. <strong>Discussion:</strong> Overall, incobotulinumtoxinA was safe and effective in CD, regardless of toxin therapy history. A lower starting dose may be better tolerated among toxin‐naïve subjects without sacrificing efficacy.</p>https://tremorjournal.org/index.php/tremor/article/view/140 |
| spellingShingle | Hubert Fernandez Eric J. Pappert Cynthia Comella Virgilio Evidente Daniel Truong Amit Verma Joseph Jankovic Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin versus Toxin-Naïve Subjects with Cervical Dystonia Tremor and Other Hyperkinetic Movements |
| title | Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin versus Toxin-Naïve Subjects with Cervical Dystonia |
| title_full | Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin versus Toxin-Naïve Subjects with Cervical Dystonia |
| title_fullStr | Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin versus Toxin-Naïve Subjects with Cervical Dystonia |
| title_full_unstemmed | Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin versus Toxin-Naïve Subjects with Cervical Dystonia |
| title_short | Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin versus Toxin-Naïve Subjects with Cervical Dystonia |
| title_sort | efficacy and safety of incobotulinumtoxina in subjects previously treated with botulinum toxin versus toxin naive subjects with cervical dystonia |
| url | https://tremorjournal.org/index.php/tremor/article/view/140 |
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