Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for Moderate-to-Severe Psoriasis: Pooled Phase 3 Analysis of Lower Extremities

April 2020 | Volume 19 | Issue 4 | Original Article | 389 | Copyright © April 2020

Published online March 20, 2020

Stephen Tyring , Leon H. Kircik , Paul Yamauchi , Abby Jacobson , Tina Lin

aUniversity of Texas Health Science Center, Houston, TX bIndiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; and Icahn School of Medicine at Mount Sinai, New York, NY cDermatology Institute & Skin Care Center, Inc., Santa Monica, CA dOrtho Dermatologics,* Bridgewater, NJ *Ortho Dermatologics is a division of Bausch Health US, LLC.

for all signs of psoriasis. Figure 3 illustrates improvement over time with HP/TAZ lotion on the leg target lesion.

At week 8, overall treatment success across all treatment areas (IGA score of 0 or 1 and ≥2-grade improvement) was achieved in 36.4% of participants treated with HP/TAZ lotion compared with 10.4% treated with vehicle (P<0.001; Figure 4). Treatment success was maintained through the 4-week posttreatment follow- up, with overall treatment success at week 12 achieved in 35.3% vs 10.9% of participants treated with HP/TAZ or vehicle, respectively (P<0.001). A significant difference in favor of HP/TAZ versus vehicle for overall treatment success was observed by week 4.

Mean overall affected BSA was reduced by 32.7% at week 8 in HP/TAZ-treated participants compared with a 1.0% reduction in vehicle-treated participants (P<0.001; Figure 5). At week 12, mean reductions in BSA were 34.8% in HP/TAZ-treated participants compared with a 7.3% increase in vehicle-treated participants (P<0.001). Mean BSA reductions were significantly greater in HP/TAZ-treated participants than vehicle-treated participants as early as week 2.

Mean percent reduction from baseline to week 8 in IGAxBSA composite score was also significantly greater with HP/TAZ treatment (-47.3%) than with vehicle (-4.5%; P<0.001) and was sustained at week 12 (-47.2% vs -8.5%; P<0.001; Figure 6). Significant reductions versus vehicle in IGAxBSA were observed as early as week 2.

A significantly greater percentage of participants in the HP/TAZ group (37.8%) compared with the vehicle group (12.7%) achieved a ≥75% reduction from baseline in IGAxBSA (IGAxBSA-75) score at week 8 (P<0.001); this difference was sustained at week 12 (45.2% vs 12.3%, respectively; P<0.001). Similarly, a significant difference in the percentage of participants with IGAxBSA-50 achievement at week 8 was also found between HP/TAZ-treated participants and those treated with vehicle (53.4% vs 14.1%, respectively; P<0.001); at week 12, the percentage of participants