ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics; Ortho Dermatologics is a division of Bausch Health US, LLC Presented at Winter Clinical Dermatology Conference 2020 • January 17-22, 2020 • Kohala Coast, HI SYNOPSIS ◾ Psoriasis is a chronic, immune-mediated disease that can have frequent exacerbations and remissions1 ◾ Topical corticosteroids are the mainstay of psoriasis treatment, particularly for mild disease,2 while systemic therapies may be useful in patients with severe disease; however, topical treatments are having an increasing role in moderate-to-severe psoriasis as an integral part of combination therapy ◾ A novel halobetasol propionate (HP) 0.01% lotion (Bryhali® Ortho Dermatologics, Bridgewater, NJ) has demonstrated efficacy versus vehicle in two phase 3 studies of patients with moderate-to-severe plaque psoriasis3,4 ◾ Few studies have examined the efficacy and safety of topical therapies for the treatment of psoriasis in Hispanic patients OBJECTIVE ◾ To evaluate the efficacy, safety, and tolerability following once-daily application of HP 0.01% lotion in Hispanic patients with moderate-to-severe plaque psoriasis METHODS ◾ In two phase 3, multicenter, double-blind studies, patients were randomized 2:1 to receive HP 0.01% or vehicle lotion once-daily for 8 weeks, with a 4-week posttreatment follow-up3,4 • At baseline, patients were required to have an Investigator Global Assessment (IGA) score of 3 or 4 (5-point scale; 0=clear and 4=severe) and affected Body Surface Area (BSA) of 3% to 12% • In these studies, CeraVe® hydrating cleanser and CeraVe® moisturizing lotion (L’Oreal, NY) were provided as needed for optimal moisturization/cleaning of the skin ◾ Data from these two studies were pooled and analyzed post hoc in a subset of self-identified Hispanic participants ◾ Efficacy assessments were as follows: • Overall treatment success (≥2-grade improvement from baseline in IGA score and a score of ‘clear’ or ‘almost clear’ [primary endpoint]) • Treatment success (≥2-grade improvement from baseline) in each individual sign of psoriasis (erythema, plaque elevation, and scaling) at the target lesion • Improvements from baseline in overall BSA • Reductions of ≥50% and ≥75% from baseline in IGAxBSA (IGAxBSA-50, IGAxBSA-75) ◾ Safety and treatment-emergent adverse events (TEAEs) were evaluated throughout the study RESULTS ◾ This analysis included 119 Hispanic participants (HP 0.01% lotion, n=76; vehicle, n=43) ◾ At week 8, significantly more HP-treated participants achieved overall treatment success compared with vehicle-treated participants; this significant difference was achieved as early as week 4 and sustained posttreatment (Figure 1) FIGURE 1. Overall Treatment Successa by Study Visit in Hispanic Participants (ITT Population, Pooled) 50% 60% 70% 40% 30% 20% 10% 0% 0 2 4 6 8 12 P e rc e n ta g e o f P a rt ic ip a n ts Treatment Posttreatment 6.6% 18.4% 33.1% 25.2% 10.2% 0% 0% 4.7% 10.3% 38.8% Study Visit (Weeks) HP 0.01% Lotion (n=76) Vehicle (n=43) *P<0.05 vs vehicle; ***P≤0.001 vs vehicle. aTreatment success was defined as a ≥2-grade improvement from baseline in IGA score and a score of ‘clear’ or ‘almost clear’ (0 or 1). HP, halobetasol propionate; IGA, Investigator Global Assessment; ITT, intent-to-treat. Efficacy and Safety of Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis in a Hispanic Population: Post Hoc Analysis of Two Phase 3 Randomized Controlled Trials ◾ Participants treated with HP 0.01% lotion achieved a significantly greater mean percent reduction from baseline in affected BSA at week 8 versus those treated with vehicle, with significant differences observed as early as week 2 (Figure 3) FIGURE 3. Mean Percent Reduction in Overall Affected Body Surface Area (BSA) by Study Visit in Hispanic Participants (ITT Population, Pooled) -10% 0% 10% -20% -30% -40% 0 2 4 6 8 12 P e rc e n t C h a n g e F ro m B a se li n e Treatment Posttreatment -4.9% -14.6% -23.3% -26.0% -11.3% 5.0% -0.8% 1.6% -9.7% -33.1% Study Visit (Weeks) HP 0.01% Lotion (n=76) Vehicle (n=43) * P<0.05 vs vehicle; ** P≤0.01 vs vehicle; *** P≤0.001 vs vehicle. HP, halobetasol propionate; ITT, intent-to-treat. ◾ At week 8, a clinically meaningful effect in overall psoriasis treatment was achieved by participants treated with HP 0.01% lotion versus those with vehicle (Figure 4) FIGURE 4. Achievement of ≥50% (IGAxBSA-50) and ≥75% (IGAxBSA-75) Reduction in IGAxBSA at Week 8 in Hispanic Participants (ITT Population, Pooled) 70% 60% 50% 40% 30% 20% 10% 0% 51.3% 16.3% IGAxBSA-50 36.8% 11.6% IGAxBSA-75 HP 0.01% Lotion (n=76) Vehicle (n=43) P e rc e n ta g e o f P a rt ic ip a n ts **P<0.01 vs vehicle; ***P<0.001 vs vehicle. BSA, Body Surface Area; HP, halobetasol propionate; IGA, Investigator Global Assessment; ITT, intent-to-treat. ◾ Treatment-related TEAEs with HP 0.01% lotion through week 8 were application site infection and application site dermatitis (n=1 each); the one treatment-related TEAE with vehicle was psoriasis ◾ CONCLUSIONS ◾ Halobetasol propionate 0.01% lotion was associated with significant, rapid, and sustained reductions in disease severity in a Hispanic population with moderate-to-severe psoriasis, with few treatment-related TEAEs over 8 weeks of once-daily use REFERENCES 1. Nestle FO, et al. N Engl J Med. 2009;361(5):496-509. 2. Menter A, et al. J Am Acad Dermatol. 2009;60(4):643-659. 3. Sugarman JL, et al. Cutis. 2019;103(2):11-116. 4. Green LJ, et al. J Drugs Dermatol. 2018;17(10):1062-1069. AUTHOR DISCLOSURES: Seemal R. Desai has served as a research investigator and/or consultant for Skinmedica, Ortho Dermatologics, Galderma, Pfizer, Dermavant, Almirall, Dermira, and Watson. Brad Glick has served as investigator, advisor, and/or speaker for AbbVie, Celgene, Janssen, Sun Pharma, Lilly, Novartis, Dermira, Sanofi/Genzyme, Regeneron, Pfizer, Dermavant, ChemoCentryx, and Ortho Dermatologics; and is a stockholder in Top MD. James Q Del Rosso has served as a consultant, investigator, and speaker for Ortho Dermatologics. Tina Lin is an employee of Ortho Dermatologics and may hold and/or stock options in its parent company. ◾ Psoriasis signs were also reduced at week 8, with more HP-treated participants achieving ≥2-grade improvement in erythema, plaque elevation, and scaling at the target lesion compared with vehicle (Figure 2) • Significant differences versus vehicle were observed in all signs of psoriasis as early as week 4 FIGURE 2. Treatment Successa in Psoriasis Signs of Erythema (A), Plaque Elevation (B), and Scaling (C) at the Target Lesion by Study Visit in Hispanic Participants (ITT Population, Pooled) 50% 60% 70% 40% 30% 20% 10% 0% 0 2 4 6 8 12 50% 60% 70% 40% 30% 20% 10% 0% 0 2 4 6 8 12 50% 60% 70% 40% 30% 20% 10% 0% 0 2 4 6 8 12 P e rc e n ta g e o f P a rt ic ip a n ts A. Erythema Treatment Posttreatment 10.5% 28.1% 42.4% 34.2% 15.6% 0.2% 2.5% 3.5% 12.9% 49.1% P e rc e n ta g e o f P a rt ic ip a n ts B. Plaque Elevation Treatment Posttreatment 15.9% 36.8% 45.3% 44.5% 23.9% 8.0% 14.7% 16.7% 25.1% 53.0% P e rc e n ta g e o f P a rt ic ip a n ts C. Scaling Treatment Posttreatment 22.4% 40.4% 50.6% 41.8% 28.6% 7.3% 12.9% 14.6% 23.9% 57.7% Study Visit (Weeks) HP 0.01% Lotion (n=76) Vehicle (n=43) Study Visit (Weeks) HP 0.01% Lotion (n=76) Vehicle (n=43) Study Visit (Weeks) HP 0.01% Lotion (n=76) Vehicle (n=43) *P<0.05 vs vehicle; **P<0.01 vs vehicle; ***P<0.001 vs vehicle. aTreatment success was defined as a ≥2-grade improvement from baseline in each individual sign of psoriasis at the target lesion. HP, halobetasol propionate; ITT, intent-to-treat. Seemal R Desai, MD1; Brad Glick, DO, MPH2; James Q Del Rosso, DO3; Tina Lin, PharmD4 1Innovative Dermatology, PA, Plano, TX and The University of Texas Southwestern Medical Center, Dallas, TX; 2GSI Clinical Research, Margate, FL; 3JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 4Ortho Dermatologics*, Bridgewater, NJ *Ortho Dermatologics is a division of Bausch Health US, LLC.