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• W4367304448 abstract "<h3>Objective:</h3> To evaluate efficacy, safety, and immunogenicity over multiple treatments of DaxibotulinumtoxinA for Injection (DAXI; DAXXIFY™), a novel botulinum toxin type A, in subjects with cervical dystonia (CD). <h3>Background:</h3> Pooled Phase 3 results are presented from placebo-controlled, single-dose (ASPEN-1) and open-label extension (ASPEN-OLS) studies. <h3>Design/Methods:</h3> In ASPEN-1, 301 adults with moderate-to-severe CD were randomized 1:3:3 (placebo:DAXI 125U:DAXI 250U) and followed for ≤36 weeks. In ASPEN-OLS, 357 subjects (271 from ASPEN-1 and 86 newly enrolled subjects) received up to 4 treatments of DAXI 125U, 200U, 250U, or 300U based on investigator decision. Re-treatment in ASPEN-OLS was based on loss of 80% of peak treatment effect or subject request and investigator judgment. <h3>Results:</h3> Across both studies, 382 subjects received 1240 DAXI treatments. Mean change from baseline (CFB) in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score, averaged over Weeks 4 and 6 post injection, increased over the 5 treatment cycles (−12.3 in ASPEN-1; −15.4, −17.7, −17.9, and −19.9 for Cycles 1–4 of ASPEN-OLS, respectively). Similar trends for increasing CFB over successive cycles were seen for TWSTRS subscales of pain (−3.0 to −5.8), disability (−3.5 to −6.0), and severity (−5.7 to −8.3). Clinical and Patient Global Impression of Change responder rates (≥2-point improvement) at Weeks 4 or 6 also increased from ASPEN-1 (58.8% and 52.2%) to Cycle 4 of ASPEN-OLS (83.1% and 69.2%). Treatment-related dysphagia was reported in 2.7% of DAXI-treated subjects in ASPEN-1 and in 3.9%, 4.3%, 4.7%, and 3.1% of subjects in ASPEN-OLS Cycles 1–4, respectively (4.2% of 985 treatments in ASPEN-OLS). The incidence of treatment-induced anti-drug antibodies was low, with no observed trend in incidence over successive doses. <h3>Conclusions:</h3> Repeat treatments with DAXI were efficacious, safe and well tolerated, with a favorable immunogenicity profile. <b>Disclosure:</b> Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acorda Therapeutics. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck LTD. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan Inc. Dr. Comella has received personal compensation in the range of $0-$499 for serving as a Consultant for Merz. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia. Dr. Comella has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion. Dr. Comella has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Aeon. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz . Dr. Comella has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz Pharmaceutical. Dr. Comella has received publishing royalties from a publication relating to health care. Dr. Comella has received publishing royalties from a publication relating to health care. Dr. Barbano has received personal compensation for serving as an employee of State of New York/Office of Mental Health. Dr. Barbano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie/Allergan. Dr. Barbano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Oscine. Dr. Barbano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Barbano has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. Dr. Barbano has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Visual Dx. Dr. Barbano has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for R L Barbano, MD,PhD, PLLC. The institution of Dr. Barbano has received research support from Fox Foundation. The institution of Dr. Barbano has received research support from Revance. The institution of Dr. Barbano has received research support from Vaccinex. The institution of Dr. Barbano has received research support from Dystonia Study Coalition. The institution of Dr. Barbano has received research support from Acadia. Dr. Barbano has received intellectual property interests from a discovery or technology relating to health care. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amneal. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving as a Video Panel with CNS Ratings LLC. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Course Organiztion with Omniprex Scientific Medical Eduaction. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with Health Monitor Network. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Movement Disorders Society. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Workshop Moderator with International Neurotoxin Association Inc. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Lecturer with CME Outfitteres LLC. Alberto B. Vasquez, MD has nothing to disclose. Todd Gross has received personal compensation for serving as an employee of Revance Therapeutics Inc. Todd Gross has stock in Revance Therapeutics Inc. Roman Rubio has received personal compensation for serving as an employee of Revance. Ms. Kooken has received personal compensation for serving as an employee of Revance Therapeutics. Ms. Kooken has stock in Revance Therapeutics . Domenico Vitarella has received personal compensation for serving as an employee of Revance." @default.
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• W4367304448 date "2023-04-25" @default.
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• W4367304448 title "Efficacy and Safety of DaxibotulinumtoxinA for Injection Over Successive Treatments in Adults With Cervical Dystonia in the Phase 3 ASPEN-1 and ASPEN-OLS Trials (P11-11.006)" @default.
• W4367304448 doi "https://doi.org/10.1212/wnl.0000000000203363" @default.
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