MEASURING THE IMPACT OF PREVIOUS TREATMENT CYCLES ON HEALTH UTILITY IN PATIENTS RECEIVING BOTULINUM TOXIN TYPE A (BONTA) IN A PROSPECTIVE OBSERVATIONAL COHORT STUDY- MOBILITY STUDY
Author(s)
Simonyi S1, Jog M2, Wein T3, Beauchamp R4, Miller R5, Ismail F6, Bhogal M1, Huang B71Allergan, Inc., Markham, ON, Canada, 2London Health Sciences Centre, London, ON, Canada, 3McGill University, Montreal, QC, Canada, 4Children's & Women's Health Centre of
OBJECTIVES: Health utility may improve over time after initiation of BoNTA treatment as injection dose and location are optimized leading to a steady state. The BOTOX Exposure Index (BEI) was developed to model the longitudinal effect of previous BoNTA exposure on health utility. METHODS: The MOBILITY study measures health utility via the SF-6D in naïve and previously-treated (maintenance) patients receiving BoNTA for various indications, including spasticity, hyperhidrosis, and dystonias. Treatment history, SF-12v2 Physical (PCS) and Mental (MCS) Component Summary scores, and SF-6D were reported. The BEI was modeled using interim study data from 795 patients. The BEI of a patient treated with dose (d) units/treatment and number (n) of previous treatment cycles is: BEI=n•d•∫f(x;ß)dx integral tf to tl where tf and tl are the time (yrs) from the first and last injections before baseline and β is the shape parameter that characterizes the expected duration of time that the treatment effect remains. The BEI was then standardized to reduce variation across indications. RESULTS: Logarithmic transformation of the BEI resulted in a more normalized distribution of BoNTA exposure, and allowed categorization into low (
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PRM23
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Multiple Diseases