AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions.
AbobotulinumtoxinA
Cervical dystonia
Dilution
Dosing flexibility
Treatment
Journal
Clinical parkinsonism & related disorders
ISSN: 2590-1125
Titre abrégé: Clin Park Relat Disord
Pays: England
ID NLM: 101761473
Informations de publication
Date de publication:
2021
2021
Historique:
received:
12
05
2021
revised:
27
10
2021
accepted:
29
10
2021
entrez:
10
12
2021
pubmed:
11
12
2021
medline:
11
12
2021
Statut:
epublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 34888518
doi: 10.1016/j.prdoa.2021.100115
pii: S2590-1125(21)00027-X
pmc: PMC8636802
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100115Informations de copyright
© 2021 The Author(s).
Déclaration de conflit d'intérêts
SHI received honoraria, consultancy, and promotional speaker fees from Ipsen. ATP received consultant and speaker fees from Ipsen. AB received consultancy fees from Ipsen. KD received advisor/consultant/speaker fees from Ipsen. LB received honoraria from Ipsen. SHI, DT, and ATP received research grants/support from Ipsen. PM is employed by Ipsen, and SW is a former employee of Ipsen.
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