Abstract Details

Title Long-term Safety of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia in Phase 3, Open-label, Multicenter ASPEN-OLS Trial

Topic Movement Disorders

Presentation(s) P11 - Poster Session 11 (11:45 AM-12:45 PM)

Poster/Presentation
Number 5-003

Objective To evaluate long-term safety and immunogenicity of up to 4 successive cervical dystonia (CD) treatments with DaxibotulinumtoxinA for Injection (DAXI; DAXXIFY™), a novel botulinum toxin (BoNT) type A with proprietary excipient peptide.

Background DAXI previously demonstrated safety and efficacy in a randomized pivotal study, ASPEN-1.

Design/Methods Adults with moderate-to-severe CD were recruited from 65 study centers in the US, Canada, and Europe. Subjects received initial open-label DAXI 125U or 250U based on BoNT treatment history, CD severity, and investigator judgment; successive DAXI treatments could be 125U, 200U, 250U, or 300U. Per-muscle injected volume was within a pre-defined dose range. Re-treatment was based on loss of 80% of peak treatment effect or subject request and investigator judgment. Subjects were followed up to Week 52

Results 357 subjects (271 from ASPEN-1, 86 de novo) received 985 DAXI treatments. Investigators placed 87% of subjects on at least 1 dose above 125U (≥250U, 77%; 300U, 37%). Commonly reported treatment-related treatment-emergent adverse events (TEAEs) (≥5% of subjects overall) were dysphagia, muscular weakness, and injection site pain. TEAE rates remained stable or decreased after repeat dosing. Treatment-related dysphagia was reported in 3.9%, 4.3%, 4.7%, and 3.1% of subjects in Cycles 1-4, respectively (4.2% of 985 DAXI treatments). There were no serious treatment-related TEAEs. The overall incidence of treatment-induced anti-drug antibodies was low, with no observed trend in incidence over successive doses.

Conclusions Repeat treatments with DAXI were safe and well tolerated, with a favorable immunogenicity profile.

Authors/Disclosures
Todd Gross (Revance) PRESENTER	Todd Gross has received personal compensation for serving as an employee of Revance Therapeutics Inc. Todd Gross has stock in Revance Therapeutics Inc.
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache)	Dr. McAllister has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for pfizer. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
H. A. Jinnah, MD, PhD, FAAN (Emory University)	Dr. Jinnah has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takaha/Ene. Dr. Jinnah has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Jinnah has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen. Dr. Jinnah has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. The institution of Dr. Jinnah has received research support from Addex. The institution of Dr. Jinnah has received research support from Aeon. The institution of Dr. Jinnah has received research support from Revance. The institution of Dr. Jinnah has received research support from Jazz.
Virgilio Gerald H. Evidente, MD, FAAN (Movement Disorders Center of Arizona)	Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Evidente has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurocrine. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Evidente has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. The institution of Dr. Evidente has received research support from CND. The institution of Dr. Evidente has received research support from Aeon. The institution of Dr. Evidente has received research support from Bukwang Pharmaceuticals. The institution of Dr. Evidente has received research support from Jazz Pharmaceuticals. The institution of Dr. Evidente has received research support from Scion Neurostim. The institution of Dr. Evidente has received research support from Theravance Biopharma. Dr. Evidente has received research support from Cerevance. Dr. Evidente has received research support from Ipsen.
Atul T. Patel	Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for IPSEN. Atul T. Patel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. Atul T. Patel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for IPSEN. The institution of Atul T. Patel has received research support from Abbvie. The institution of Atul T. Patel has received research support from IPSEN.
Roman Rubio	Roman Rubio has received personal compensation for serving as an employee of Revance.
Domenico Vitarella (Revance)	No disclosure on file

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