27611 Fixed-combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion for the treatment of plaque psoriasis in patients with 3-5% body surface area (BSA) and poor quality of life (QoL)

Abstract

Use of TAZ with topical steroids, such as superpotent HP, is recommended for mild-to-moderate psoriasis as the combination may provide synergistic efficacy while increasing duration of treatment effect and remission. The objective of this analysis was to investigate HP 0.01%/TAZ 0.045% lotion in patients with relatively low affected BSA and poor QoL, as objective measures such as BSA may underestimate disease severity. Two phase 3, multicenter, double-blind studies enrolled 418 adults with 3-12% BSA and Investigator’s Global Assessment (IGA) score of 3 or 4 (‘moderate’ or ‘severe’) at baseline. Participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once-daily for 8 weeks, with a 4-week posttreatment follow-up. Pooled, post hoc analyses were conducted in a subset of 65 participants with baseline BSA of 3-5% and Dermatology Life Quality Index (DLQI) score ≥11. At week 8, 50.3% of HP/TAZ-treated participants achieved treatment success (≥2-grade reduction from baseline in IGA and score of 0 or 1 [‘clear’ or ‘almost clear’]), vs 14.6% of vehicle-treated participants (P ˂ .05). BSA was significantly reduced with HP/TAZ ( 39.2%) vs vehicle lotion (+15.9%; P ˂ .05). The percentage of participants experiencing a clinically meaningful ≥4-point reduction in DLQI score was greater for HP/TAZ (85.3%) vs vehicle (55.6%). Numerical improvements with HP/TAZ lotion were maintained 4-weeks posttreatment for efficacy measures and DLQI, consistent with the overall population. Though analyses were limited by the small population, HP/TAZ lotion provided significantly greater efficacy vs vehicle in participants with low BSA and poor QoL, with clinically relevant improvements in QoL.