THE RELATIONSHIP OF QUALITY OF LIFE AND COMPLETE PSORIASIS CLEARANCE OVER TIME – ANALYSES FROM BRODALUMAB TRIAL DATASETS
Author(s)
Gibbons CJ1, Hansen JB2, Merrall EL2
1LEO Pharma, Hurley, UK, 2LEO Pharma A/S, Ballerup, Denmark
OBJECTIVES: We analysed the DLQI and PASI scores from the pivotal active-comparator brodalumab studies AMAGINE-2 and AMAGINE-3, in order to better understand the dynamic relationship of quality of life (QoL) and complete psoriasis clearance (defined as 100% reduction in PASI score or PASI 100) over time. METHODS: Pooling data from the two identically-designed pivotal trials, we defined two groups of subjects receiving constant brodalumab (n=339) or constant ustekinumab (n=590) over the extended 52 week study period. Subjects’ attainment of PASI 100 (“complete clearance”) and DLQI score 0 or 1 (“no impact of disease on QoL”) was described throughout this period, and their time to first attainment was calculated and compared. Analyses were separated according to study drug (ustekinumab or brodalumab) to assess whether treatment had any impact on the relationship of DLQI and complete clearance. RESULTS: At week 52, 51% and 55% of brodalumab patients maintained PASI 100 or DLQI 0/1 respectively, and 43% maintained both. For ustekinumab patients, the corresponding percentages were 28% and 40% for PASI 100 and DLQI 0/1, and 24% had both. Over time, DLQI 0/1 tended to occur earlier than PASI 100, although the two followed a similar pathway generally. The median times to attainment of PASI 100 and DLQI 0/1 were 98 days and 56 days respectively for brodalumab patients, compared to 168 and 86 days for ustekinumab patients. The difference by treatment in time to attainment was statistically significant for both outcomes. CONCLUSIONS: Patient DLQI score improved with biologic treatment along a timeframe comparable to PASI 100, although a DLQI score of 0/1 was generally achieved before PASI 100 was achieved. The more efficacious biologic, brodalumab, was associated with quicker and higher rates of attainment of complete clearance as well as DLQI 0/1 compared to ustekinumab.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PSS29
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes, Stated Preference & Patient Satisfaction
Disease
Sensory System Disorders