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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

To assess the residual therapeutic efficacy of prior botulinum toxin (BoNT) injection at the patient-desired retreatment interval in cervical dystonia (CD).
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.
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 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.
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 $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoparkinson. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Intrance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NanoPharmasolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll BioPharma. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Cerevance. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clario. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sumitomo. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Taurus Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sorriddi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Contera. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alterity Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Convatec Inc. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Knight Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biorasi. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medicure Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock. 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. The institution of 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 Stoparkinson. The institution of Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Photopharmics. The institution of Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Hauser has or had stock in Inhibikase.Dr. Hauser has or had stock in Axial Therapeutics.Dr. Hauser has or had stock in Enterin.Dr. Hauser has or had stock in Photopharmics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. 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 Biogen MA. 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 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 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 Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from UCB BioPharma. The institution of Dr. Hauser has received research support from UCB. The institution of Dr. Hauser has received research support from Amneal Pharmaceuticals. The institution of Dr. Hauser has received research support from Motric Bio, Inc.. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research Company. The institution of Dr. Hauser has received research support from Teva Branded Pharmaceuticals. The institution of Dr. Hauser has received research support from Truebinding, Inc.. The institution of Dr. Hauser has received research support from Jazz Pharmaceuticals. The institution of Dr. Hauser has received research support from Ipsen. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
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.
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