Objective: To evaluate efficacy and safety of a single injection of abobotulinumtoxinA using 1-mL or 2-mL dilution in adults with CD.

Background: AbobotulinumtoxinA is approved (US only) for the treatment of cervical dystonia (CD) using 1-mL or 2-mL dilution. Dilution flexibility allows clinicians to individualize patient care, which may improve patient outcomes.

Method: AbobotulinumtoxinA was evaluated in 3 double-blind, placebo-controlled trials (1 mL: Trials 1 and 2; 2 mL: Trial 3). In Trials 1 and 2, patients were randomized to abobotulinumtoxinA 500 U or placebo.  In Trial 3, patients were randomized to abobotulinumtoxinA (500 U if toxin-naïve at baseline; 250-500 U based on previous onabotulinumtoxinA dose, if non-naïve) or placebo.  Eligible adults had primary idiopathic CD, baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score ≥20 (2 mL) or ≥30 (1 mL) and TWSTRS-severity subscale score >10 (2 mL) or ≥15 (1 mL). The primary efficacy endpoint was change in TWSTRS total score (Week 4 – baseline). Treatment-emergent adverse events (TEAEs) were assessed.

Results: In Trial 1 (n=80), 37 patients received abobotulinumtoxinA; 43 placebo. In Trial 2 (n=116), 55 patients received abobotulinumtoxinA; 61 placebo. In Trial 3 (n=133) 88 patients received abobotulinumtoxinA; 45 placebo. All trials met the primary endpoint (Trial 1: Δ-6.0, P=0.013; Trial 2: Δ-8.8, P<0.001; Trial 3: Δ-8.3, P<0.001). AbobotulinumtoxinA’s safety profile was similar across trials. Dysphagia was the most common TEAE (9-16%).

Conclusion: Although trial designs differed, abobotulinumtoxinA was efficacious using 1-mL or 2-mL dilution, offering treatment flexibility and individualized patient care. Safety and tolerability were similar across trials.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-and-safety-of-abobotulinumtoxina-in-adults-with-cervical-dystonia-similar-results-between-1ml-and-2ml-dilution-methods/