AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions
Introduction: Cervical dystonia (CD) is a neurologic movement disorder with potentially disabling effects and significant impact on quality of life of those affected. AbobotulinumtoxinA (aboBoNT-A) was initially approved for a dilution of 500 U/1 mL and subsequently for a dilution of 500 U/2 mL, pro...
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Elsevier
2021
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oai:doaj.org-article:1b10f3346552463da42e87acfb1713612021-11-28T04:37:41ZAbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions2590-112510.1016/j.prdoa.2021.100115https://doaj.org/article/1b10f3346552463da42e87acfb1713612021-01-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S259011252100027Xhttps://doaj.org/toc/2590-1125Introduction: Cervical dystonia (CD) is a neurologic movement disorder with potentially disabling effects and significant impact on quality of life of those affected. AbobotulinumtoxinA (aboBoNT-A) was initially approved for a dilution of 500 U/1 mL and subsequently for a dilution of 500 U/2 mL, providing flexibility for clinicians to treat CD. Here, we explore the safety and efficacy of the 500 U/2 mL dilution versus 500 U/1 mL dilution of aboBoNT-A in a retrospective analysis based on published clinical trial data. Methods: The safety and efficacy of aboBoNT-A in patients with CD was evaluated in three multicenter, double-blind, randomized, placebo-controlled trials and open-label extensions. Trials 1 (NCT00257660) and 2 (NCT00288509) evaluated the 500 U/1 mL dilution in 80 and 116 patients, respectively; Trial 3 (NCT01753310) evaluated the 500 U/2 mL dilution in 125 patients. Results: Comparison of the adjusted mean difference in TWSTRS total scores at Week 4 from baseline for aboBoNT-A in Trial 1 (−6.0; 95% CI, −10.8, −1.3), Trial 2 (−8.8; 95% CI, −12.9, −4.7), and Trial 3 (−8.7; 95% CI, −13.2, −4.2) showed similar, significant improvements. Dysphagia and muscle weakness patterns were comparable across the three trials, indicating that an increased dilution of aboBoNT-A does not result in an increased risk of diffusion-related adverse events. Conclusion: The results of these trials show that aboBoNT-A is similarly efficacious using either dilution, with similar safety and tolerability across trials. Having the 500 U/1 mL and 500 U/2 mL dilution volumes available provides further flexibility in administration, benefiting patient care.Mark F. LewRobert A. HauserStuart H. IsaacsonDaniel TruongAtul T. PatelAllison BrashearWilliam OndoPascal MaisonobeKhashayar DashtipourLaxman BahrooStefan WietekElsevierarticleAbobotulinumtoxinACervical dystoniaDosing flexibilityDilutionTreatmentNeurology. Diseases of the nervous systemRC346-429ENClinical Parkinsonism & Related Disorders, Vol 5, Iss , Pp 100115- (2021) |
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EN |
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AbobotulinumtoxinA Cervical dystonia Dosing flexibility Dilution Treatment Neurology. Diseases of the nervous system RC346-429 |
| spellingShingle |
AbobotulinumtoxinA Cervical dystonia Dosing flexibility Dilution Treatment Neurology. Diseases of the nervous system RC346-429 Mark F. Lew Robert A. Hauser Stuart H. Isaacson Daniel Truong Atul T. Patel Allison Brashear William Ondo Pascal Maisonobe Khashayar Dashtipour Laxman Bahroo Stefan Wietek AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions |
| description |
Introduction: Cervical dystonia (CD) is a neurologic movement disorder with potentially disabling effects and significant impact on quality of life of those affected. AbobotulinumtoxinA (aboBoNT-A) was initially approved for a dilution of 500 U/1 mL and subsequently for a dilution of 500 U/2 mL, providing flexibility for clinicians to treat CD. Here, we explore the safety and efficacy of the 500 U/2 mL dilution versus 500 U/1 mL dilution of aboBoNT-A in a retrospective analysis based on published clinical trial data. Methods: The safety and efficacy of aboBoNT-A in patients with CD was evaluated in three multicenter, double-blind, randomized, placebo-controlled trials and open-label extensions. Trials 1 (NCT00257660) and 2 (NCT00288509) evaluated the 500 U/1 mL dilution in 80 and 116 patients, respectively; Trial 3 (NCT01753310) evaluated the 500 U/2 mL dilution in 125 patients. Results: Comparison of the adjusted mean difference in TWSTRS total scores at Week 4 from baseline for aboBoNT-A in Trial 1 (−6.0; 95% CI, −10.8, −1.3), Trial 2 (−8.8; 95% CI, −12.9, −4.7), and Trial 3 (−8.7; 95% CI, −13.2, −4.2) showed similar, significant improvements. Dysphagia and muscle weakness patterns were comparable across the three trials, indicating that an increased dilution of aboBoNT-A does not result in an increased risk of diffusion-related adverse events. Conclusion: The results of these trials show that aboBoNT-A is similarly efficacious using either dilution, with similar safety and tolerability across trials. Having the 500 U/1 mL and 500 U/2 mL dilution volumes available provides further flexibility in administration, benefiting patient care. |
| format |
article |
| author |
Mark F. Lew Robert A. Hauser Stuart H. Isaacson Daniel Truong Atul T. Patel Allison Brashear William Ondo Pascal Maisonobe Khashayar Dashtipour Laxman Bahroo Stefan Wietek |
| author_facet |
Mark F. Lew Robert A. Hauser Stuart H. Isaacson Daniel Truong Atul T. Patel Allison Brashear William Ondo Pascal Maisonobe Khashayar Dashtipour Laxman Bahroo Stefan Wietek |
| author_sort |
Mark F. Lew |
| title |
AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions |
| title_short |
AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions |
| title_full |
AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions |
| title_fullStr |
AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions |
| title_full_unstemmed |
AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions |
| title_sort |
abobotulinumtoxina provides flexibility for the treatment of cervical dystonia with 500 u/1 ml and 500 u/2 ml dilutions |
| publisher |
Elsevier |
| publishDate |
2021 |
| url |
https://doaj.org/article/1b10f3346552463da42e87acfb171361 |
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