Objective: We present efficacy, patient-reported outcomes (PROs), and safety in adults with cervical dystonia (CD) at last available visit after a single abobotulinumtoxinA injection using 2 mL dilution.

Background: CD is a neurological movement disorder of the neck muscles negatively impacting functionality and quality of life. Treatment with botulinum toxin occurs at intervals of ≥12 weeks in patients with CD.

Method: This was a 12-week, randomized, double-blind trial (NCT01753310). Eligible patients were ≥18yrs with primary idiopathic CD, Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score ≥20, and TWSTRS-severity subscale score >10 at baseline. Patients were randomized (2:1) to abobotulinumtoxinA or placebo, with abobotulinumtoxinA patients treated with 500U if toxin-naïve and 250-500U based on previous onabotulinumtoxinA dose if non-naïve. Endpoints included TWSTRS, Pain Numeric Rating Scale (NRS-Pain; 24-hour), Treatment Satisfaction Questionnaire for Medication, and other PROs for pain, depression, and global health. Results are for the intent-to-treat population, with “Week 12” (Wk12) comprising the last available post-baseline assessment (end-of-study or early-withdrawal).

Results: 134 patients were randomized (abobotulinumtoxinA, n=89; placebo, n=45). Mean TWSTRS total scores improved from 42.5 at baseline to 35.4 at Wk12 with abobotulinumtoxinA and 42.4 to 40.4 with placebo (treatment difference: -4.8; 95%CI: -8.5, -1.1; P=0.011). At Wk12, mean (95%CI) change from baseline in NRS-Pain was -1.0 (-1.59, -0.45) for abobotulinumtoxinA and -0.2 (-0.96, 0.65) for placebo. AbobotulinumtoxinA demonstrated numerical improvements in other PROs. More abobotulinumtoxinA-treated than placebo-treated patients were at least somewhat satisfied with treatment (60.5% vs 42.2%, respectively), symptom relief (57.0% vs 40.0%), and time for treatment to work (55.8% vs 33.3%) at Wk12. Adverse events were consistent with the known safety profile of abobotulinumtoxinA in this population.

Conclusion: Results indicate that treatment with abobotulinumtoxinA using 2 mL dilution provided sustained functional benefits including patient-perceived benefits through up to 12 weeks in patients with CD. Most patients indicated satisfaction with abobotulinumtoxinA.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/sustained-functional-benefits-after-a-single-injection-with-abobotulinumtoxina-using-a-2ml-injection-volume-in-adults-with-cervical-dystonia/