DAXI emerges as promising therapy for cervical dystonia
DaxibotulinumtoxinA for Injection (DAXI) at doses of 125U and 250U showed significant efficacy in improving the symptoms of cervical dystonia (CD) compared to placebo, according to a study.
The ASPEN-1 trial, a Phase 3, randomized, double-blind, placebo-controlled study, investigated the efficacy, duration of response, and safety of DAXI in adults with moderate-to-severe CD. Participants were randomly assigned to receive single-dose intramuscular injections of DAXI at doses of 125U or 250U, or placebo, and were followed for up to 36 weeks.
The primary endpoint of the study was the change from baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score averaged across weeks 4 and 6. Key secondary endpoints included the duration of effect, Clinical and Patient Global Impression of Change (CGIC, PGIC), TWSTRS subscale scores, and safety parameters.
Results from the trial found significant improvements in the mean TWSTRS total score with both doses of DAXI compared to placebo. The median duration of effect was approximately 20-24 weeks, indicating a long-lasting response to treatment. Additionally, DAXI demonstrated significant improvements in CGIC and PGIC responder rates, as well as TWSTRS subscale scores.
DAXI was found to be well-tolerated. Injection site pain was the most common adverse event overall.
Reference
Comella CL, Jankovic J, Hauser RA, et al; ASPEN-1 Study Group. Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia: ASPEN-1 Phase 3 Randomized Controlled Trial. Neurology. 2024;102(4):e208091. doi: 10.1212/WNL.0000000000208091. Epub 2024 Jan 31. PMID: 38295339.
