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. 2021 Nov 20:5:100115.
doi: 10.1016/j.prdoa.2021.100115. eCollection 2021.

AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions

Mark F Lew  1 , Robert A Hauser  2 , Stuart H Isaacson  3 , Daniel Truong  4 , Atul T Patel  5 , Allison Brashear  6 , William Ondo  7 , Pascal Maisonobe  8 , Khashayar Dashtipour  9 , Laxman Bahroo  10 , Stefan Wietek  11
Affiliations

AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions

Mark F Lew et al. Clin Park Relat Disord. .

Abstract

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.

Keywords: AbobotulinumtoxinA; Cervical dystonia; Dilution; Dosing flexibility; Treatment.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Adjusted mean difference in TWSTRS total score at Week 4. Reprinted from International Journal of Neuroscience, Vol. 128, Lew MF, Brashear A, Dashtipour K, Isaacson S, Hauser RA, Maisonobe P, Snyder D, Ondo W. Pages 619–626, 2018, with permission from Taylor & Francis Ltd (https://www.tandfonline.com/). *Trial 3 results are presented in summary (250–500 U) and by subgroup (500 U vs. < 500 U). aboBoNT-A, abobotulinumtoxinA; CI, confidence interval; TWSTRS, Toronto Western Spasmodic Torticollis Rating Scale; U, units.
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