Abstract Details

Title An International, Multicenter, Observational, Longitudinal Study to Assess the Effectiveness of AbobotulinumtoxinA Injections for Adult Lower Limb Spasticity: The AboLiSH Study

Topic Neuro-rehabilitation

Presentation(s) P7 - Poster Session 7 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-012

Objective To assess the longitudinal attainment of person-centered and function-related goals after one or more abobotulinumtoxinA injections in the lower limb over 16 months in a real-life clinical setting.

Background The ABOLiSH study (NCT04050527) is a prospective, international, longitudinal real-life clinical observational study.

Design/Methods Eligible participants are aged ≥18 years with unilateral adult lower limb spasticity, able to take ≥5 steps with or without assistance, and for whom the decision has already been made to inject abobotulinumtoxinA in accordance with local prescribing guidelines (maximum dose 1500U). Participants can be naive to botulinum toxin or previously treated and injection parameters will be documented at every visit where abobotulinumtoxinA is injected (including technique, injection intervals and rehabilitation interventions). At baseline, and all subsequent treatment cycles, participants (±caregiver) in consultation with the care provider will choose one primary goal and up to two secondary goals related to lower limb spasticity using SMART criteria. Adjustments in goal selection are permitted in different treatment cycles. Goal attainment will be assessed at a relevant time (determined by the investigator) within each injection cycle.

Results The primary endpoint is goal attainment as assessed using the cumulated GAS-leg T score, across all cycles for each subject. Correlations of patient-centered goals and related standardized rating scales will be assessed. Investigator and participant satisfaction with treatment (Global Assessment of Benefit) and quality of life will also be assessed.

Conclusions Given the diversity of spasticity clinical presentation and response to intervention, goals for treatment and resulting management plans, it is important to collect longitudinal data to measure progression in treatment outcomes (specifically goal attainment). This approach also allows evaluation of the key factors influencing decision making for adult lower-limb spasticity management and the development of appropriate educational interventions to address the findings.

Authors/Disclosures
Alberto Esquenazi, MD (Department of Physical Medicine and Rehabilitation) PRESENTER	Dr. Esquenazi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen and Allergan. Dr. Esquenazi 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 and Allergan. The institution of Dr. Esquenazi has received research support from Ipsen, Allergan and Merz.
Stephen Ashford	Stephen Ashford has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Stephen Ashford has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen. Stephen Ashford has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ipsen. The institution of Stephen Ashford has received research support from Ipsen.
Allison Brashear, MD, MBA, F�鶹��ýӳ�� (Univeristy of Buffalo)	Dr. Brashear has received personal compensation for serving as an employee of McKnight Brain Res Found. Dr. Brashear has received personal compensation for serving as an employee of American Board of Psychiatry and Neurology. Dr. Brashear has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for ABPN. Dr. Brashear has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for McKnight Brain Research Foundation i. Dr. Brashear has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Care Directions- start up . Dr. Brashear has stock in Caredirections . The institution of Dr. Brashear has received research support from NINDS. Dr. Brashear has received publishing royalties from a publication relating to health care. Dr. Brashear has received personal compensation in the range of $500-$4,999 for serving as a Special government employee and study section reviewer with NIH. Dr. Brashear has received personal compensation in the range of $0-$499 for serving as a Adminstrative board -travel reimbursement with AAMC.
Pascal Maisonobe	Pascal Maisonobe has received personal compensation for serving as an employee of ipsen pharma. Pascal Maisonobe has received personal compensation for serving as an employee of Ipsen.
Andreas Lysandropoulos (Parexel)	Andreas Lysandropoulos has nothing to disclose.

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