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

Figure 2Figure 3Figure 4in the IGA score, and a score of “Clear” or “Almost Clear” (treatment success). HP/TAZ lotion demonstrated statisticallysignificant superiority over vehicle as early as week 2 (P equals 0.002). By week 8, 40.7% of subjects in the HP/TAZ group achieved the primary efficacy outcome compared with 9.9% in the vehicle group (P less than 0.001; Figure 2). HP/TAZ lotion demonstrated a sustained therapeutic effect following the 4-week post-treatment period with 33.3% of subjects assessed as treatment successes at week 12, compared with 8.7% of subjects who had been treated with vehicle (P less than 0.001). Overall, 41.6% of subjects who had moderate disease (IGA = 3) at baseline were treatment successes with HP/TAZ lotion at week 8, compared with 11.8% of subjects treated with vehicle. Over a third (34.8%) of subjects with severe disease (IGA = 4) were treatment successes, with at least a 3-grade improvement in IGA. No subjects with severe psoriasis treated withvehicle achieved treatment success at week 8 (see Figure 3).

Severity of Psoriasis Signs (Erythema, Plaque Elevation, and Scaling) at Target Lesion Site

HP/TAZ lotion was statistically superior to vehicle in reducing the psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At week 8, at least a 2-grade improvement from baseline (treatment success) in severity of psoriasis signs was achieved by 47.0% (erythema), 59.5% (plaque elevation), and 61.2% (scaling) of subjects; compared with 14.5%, 19.7% and 20.8%, respectively, with vehicle (all P less than 0.001; Figure 4). HP/TAZ lotion demonstrated a sustained therapeutic effect in improving psoriasis signs four-weeks post-treatment. At week 12, treatment success was maintained in 43.4% (erythema), 51.4% (plaque elevation), and 49.6% (scaling) of subjects.BSA AssessmentHP/TAZ lotion was statistically superior to vehicle in reducing BSA. At week 8 there was a 37.6% reduction in mean BSA (P5 (mean, 8.5), there was a 39.7% reduction in BSA by week 8 that was maintained through week 12 (33.7%), compared with a 5.5% and 4.3% reduction in baseline BSA with vehicle at week 8 and 12.

Safety Evaluation

Overall, 97 subjects treated with HP/TAZ lotion reported AEs (35.9%) compared with 30 (21.4%) with vehicle (Table 3). The