Safety and Efficacy of a Fixed Combination Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies
August 2018 | Volume 17 | Issue 8 | Original Article | 855 | Copyright © August 2018
Jeffrey L. Sugarman MD PhD,a Jonathan Weiss MD,b Emil A. Tanghetti MD,c Jerry Bagel MD,d Paul S. Yamauchi MD,e Linda Stein Gold MD,f Tina Lin, PharmD,g Gina Martin MOT,h Radhakrishnan Pillai PhD,h Robert Israel MDi
aUniversity of California, San Francisco, CA bGwinnett Dermatology, PC, and Gwinnett Clinical Research Center, Inc, Snellville, GA cCenter for Dermatology and Laser Surgery, Sacramento, CA dPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ eDavid Geffen School of Medicine at UCLA, Los Angeles, CA fHenry Ford Hospital, Detroit, MI gOrtho Dermatologics, Bridgewater, NJ hDow Pharmaceutical Sciences Inc. (a division of Valeant Pharmaceuticals, North America, LLC.), Petaluma, CA iBausch Health, Bridgewater, NJ
Overall, 418 subjects from 32 study centers in the United States were randomized to HP/TAZ lotion or vehicle (Figure 1) andincluded in the ITT population. Across the two studies, 85.5% (N=236) and 83.8% (N=119) of subjects treated with HP/TAZ lotion or vehicle completed treatment. Main reasons for discontinuation with HP/TAZ lotion were subject request (6.2%, N=17), AEs (4.0%, N=11), or lost to follow-up (3.3%, N=9). Subject request (8.5%, N=12) was also the main reason for discontinuation in the vehicle arms. A total of 410 subjects were included in the safety population,with no post-baseline safety evaluation in 8 subjects.
Subject Demographics and Baseline Characteristics
Demographic data were comparable across the two studies. Mean age was 50.3 years (SD 13.84). Overall, the majority of subjects were male (65.1%, N=272) and Caucasian (85.6%, N=358; Table 1). Baseline disease characteristics were also comparable across the treatment groups. At baseline, subjects had moderate (85.2%, N=356) or severe (14.8%, N=62) disease, with a mean BSA of 5.9 (SD 2.76). Mean size of target lesion was 37.5cm2 (SD 22.85). The majority of subjects had moderate (erythema [79.2%], plaque elevation [76.6%], and scaling [72.5%]) or severe (erythema [12.2%], plaque elevation [12.9%], and scaling [13.6%]) signs of psoriasis at the target lesion site (Table 2).
Investigator’s Global Assessment (IGA) of Disease Severity HP/TAZ lotion was consistently more effective than its vehicle in achieving at least a 2-grade improvement from baseline