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Abstract Details

Efficacy Remaining at Time of Requested Retreatment Following Botulinum Toxin Treatment for Cervical dystonia: Potential for a New Treatment Paradigm with DaxibotulinumtoxinA
Movement Disorders
P1 - Poster Session 1 (8:00 AM-9:00 AM)
3-015
BoNT injections are standard of care for the symptomatic treatment of CD. Therapeutic efficacy often wanes after 8-10 weeks leading to symptom re-emergence between injections, as current FDA product labeling restricts treatments to every 12 weeks.  The amount of therapeutic efficacy remaining when patients would like to be retreated for their CD symptoms is not well understood.

To assess the residual therapeutic efficacy of prior botulinum toxin (BoNT) injection at the patient-desired retreatment interval in cervical dystonia (CD).

A post-hoc analysis of the Phase III ASPEN-1 and ASPEN-OLS trials for daxibotulinumtoxinA (Daxxify®) in CD was conducted. These trials allowed patients to request retreatment rather than wait until returning to pretreatment symptom levels. The median percent efficacy remaining, as determined by changes in peak TWSTRS total score, was determined in subjects who requested reinjection prior to loss of 80% of peak efficacy. This estimate of percentage of efficacy remaining at preferred reinjection was then mapped across the full study population.
A total of 72 (28.2%), 118 (33.1%), and 113 (34.9%) patients requested reinjection prior to loss of 80% of peak efficacy in ASPEN-1, ASPEN-OLS cycles 1-2. The median percent efficacy remaining was 45.3%, 41.6%, and 49.2% at the time of requested reinjection in each of the treatment cycles. The time to loss of 50% efficacy in the overall population was 16.7, 16.6, and 16.3 weeks, respectively.
These findings demonstrate, for the first time, a significant proportion of efficacy remained in patients who requested BoNT reinjection for their CD symptoms. With the long duration of benefit of daxibotulinumtoxinA, there is opportunity for a new approach whereby physicians can tailor treatments to individual patient needs and treat patients as their symptoms re-emerge at 12 weeks or beyond.
Authors/Disclosures
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache)
PRESENTER
Dr. McAllister has received personal compensation for serving as an employee of Revance. Dr. McAllister has received personal compensation for serving as an employee of AbbVie. Dr. McAllister has received personal compensation for serving as an employee of Merz. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon. 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 $500-$4,999 for serving on a Speakers Bureau for teva. 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 $5,000-$9,999 for serving on a Speakers Bureau for biohaven. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
Aaron Ellenbogen, DO Dr. Ellenbogen has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for allergan. Dr. Ellenbogen has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for allergan. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ipsen. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda.
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center) Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Global Kinetics Consulting (GKC). Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jazz Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroDerm. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scion Neurostim LLC. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tolmar Inc.. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus Pharma. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Inhibikase. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pharma 2 B. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vivifi Biotech. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage Therapeutics. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orion. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ovid Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AgeX Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avanex. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MDCE Suzhou. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedRhythms. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PDNeurotechnology. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Regenxbio. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Tremor Research Support Group. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tris Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Ameal . Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sunovion. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Cerevel. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Inhibikase. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has stock in Inhibikase. Dr. Hauser has stock in Axial Therapeutics. Dr. Hauser has stock in Enterin. Dr. Hauser has stock in Revance Therapeutics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Artizan Biosciences. The institution of Dr. Hauser has received research support from Parkinsons & Movement Disorder Alliance. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Aeon Biopharma. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Bukwang Pharmaceutical Co., Ltd.. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Cynapsus Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Impax Labratories. The institution of Dr. Hauser has received research support from Integrative Research Labratories Sweden. The institution of Dr. Hauser has received research support from Lundbeck, Inc.. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuraly Inc.. The institution of Dr. Hauser has received research support from Neurocrine Biosciences. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Pharma Two B Ltd.. The institution of Dr. Hauser has received research support from Revance Therapeutics. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Sanofi Pharmaceuticals. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from SunPharma. The institution of Dr. Hauser has received research support from UCB BioPharma. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Atul T. Patel Atul T. Patel, 15908 has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. Atul T. Patel, 15908 has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Atul T. Patel, 15908 has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen. Atul T. Patel, 15908 has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. Atul T. Patel, 15908 has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for IPSEN. The institution of Atul T. Patel, 15908 has received research support from Allergan. The institution of Atul T. Patel, 15908 has received research support from Revance. The institution of Atul T. Patel, 15908 has received research support from IPSEN.
Domenico Vitarella (Revance) No disclosure on file
Todd Gross (Revance) Todd Gross has received personal compensation for serving as an employee of Revance Therapeutics Inc. Todd Gross has stock in Revance Therapeutics Inc.
Rashid Kazerooni Rashid Kazerooni has received personal compensation for serving as an employee of Merz Therapeutics.
Conor Gallagher (Revance Therapeutics) No disclosure on file
David Hollander No disclosure on file