ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics | Presented at the Fall Clinical Dermatology Conference • October 17-20, 2019 • Las Vegas, NV SYNOPSIS ◾ Psoriasis treatment includes both topical and systemic therapies, with treatment type selected based on a variety of considerations—including disease severity, patient preference, and efficacy ◾ Topicals are considered first-line therapy for mild disease1 and systemic therapies may be useful in patients with more severe disease; however, topical treatments are having an increasing role in moderate-to-severe psoriasis as an integral part of combination therapy ◾ Recently, a novel halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion formulation has demonstrated efficacy versus vehicle for the treatment of moderate or severe plaque psoriasis,2, 3 and the combination of these two agents in this formulation demonstrated a synergistic benefit4 ◾ No direct comparative studies have been conducted between HP/TAZ and systemic therapies such as apremilast (Otezla®), an oral treatment approved in patients with moderate-to-severe plaque psoriasis OBJECTIVES ◾ To evaluate efficacy of a once-daily fixed combination of HP/TAZ lotion compared with vehicle in a subgroup of patients with moderate plaque psoriasis ◾ To place HP/TAZ results in context with published data from the oral treatment apremilast5 METHODS ◾ This analysis was a pooled post hoc analysis of two phase 3, multicenter, double-blind, vehicle-controlled studies (NCT02462070 and NCT02462122)2 ◾ Participants in the phase 3 studies were randomized (2:1) to receive HP/TAZ or vehicle lotion once-daily for 8 weeks, with a 4-week posttreatment follow-up ◾ Analyses were conducted in a subset of participants with a baseline Investigator Global Assessment (IGA) score of 3 (moderate) and Body Surface Area (BSA) 5-10% ◾ Efficacy assessments included: • Mean percent change from baseline in 5-point IGAxBSA scores • Percentage of participants with a ≥75% reduction in mean IGAxBSA (IGAxBSA-75) ◾ The subgroup population analyzed in these post hoc analyses aligns closely with the population analyzed in a published phase 4 study of oral apremilast5 • In this apremilast study, patients with a static Physician’s Global Assessment (PGA) score=3 were randomized (2:1) to twice-daily active treatment or placebo for 16 weeks; assessments included the 6-point PGAxBSA and PGAxBSA-75 RESULTS ◾ This analysis included 163 participants in the HP/TAZ study (HP/TAZ, n=100; vehicle, n=63) and 221 participants in the apremilast study (apremilast, n=148; placebo, n=73) ◾ Age, sex, and mean baseline BSA and IGAxBSA scores in the HP/TAZ analysis population were similar to those enrolled in the apremilast study (Table 1) TABLE 1: Baseline Demographics and Disease Characteristics (ITT Population) HP/TAZ Pooled Analysis Apremilast Studya HP/TAZ (n=100) Vehicle (n=63) Apremilast (n=148) Placebo (n=73) Age, mean (SD), years 49.4 (15.7) 50.9 (14.9) 48.6 (15.4) 51.1 (13.7) Male, n (%) 63 (63.0) 38 (60.3) 74 (50.0) 41 (56.2) IGAxBSA score, mean (SD)b 20.9 (5.0) 18.7 (4.3) 21.8 (5.3) 21.6 (5.9) BSA, mean (SD) 7.0 (1.7) 6.2 (1.4) 7.2 (1.6) 7.1 (1.8) DLQI total score, mean (SD) 7.2 (5.4) 8.4 (5.8) 11.0 (6.5) 11.1 (6.5) aStrober et al. 2017.5 bAssessment was PGAxBSA in apremilast study BSA, body surface area; DLQI, Dermatology Life Quality Index; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent-to-treat; PGA, Physician’s Global Assessment. Efficacy of Halobetasol 0.01%/Tazarotene 0.045% (HP/TAZ) Fixed Combination in the Treatment of Moderate Plaque Psoriasis: Indirect Comparison Between Pooled Phase 3 Trials of HP/TAZ and Oral Treatment (Apremilast) Brad Glick, DO, MPH1; Edward Lain, MD, MBA2; Tina Lin, PharmD3; Robert Israel, MD4 1GSI Clinical Research, Margate, FL; 2Austin Institute for Clinical Research, Austin, TX; 3Ortho Dermatologics, Bridgewater, NJ; 4Bausch Health, Bridgewater, NJ ◾ At Week 8, HP/TAZ-treated participants had a 46% mean reduction from baseline in IGAxBSA scores compared with a 16% reduction in vehicle-treated participants (P<0.001; Figure 1 and Figure 3A) • This effect was sustained during the 4-week posttreatment period, with a 40% reduction from baseline in IGAxBSA score with HP/TAZ at the end of 12 weeks (Figure 1) FIGURE 1: Mean Percent Reduction From Baseline in IGAxBSA Score By Study Visit (ITT Population) -60% -50% -40% -30% -20% -10% 0% Study Visit (Weeks) M e a n P e rc e n t C h a n g e f ro m B a se lin e Baseline 2 4 6 8 12 Treatment Posttreatment HP/TAZ (n=100) Vehicle (n=63) **P<0.001 vs vehicle (=0.001 at Week 12). BSA, body surface area; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent-to-treat. ◾ The percentage of participants with a ≥75% reduction from baseline IGAxBSA at Week 8 was significantly higher following treatment with HP/TAZ lotion (33.0%) compared with vehicle (9.5%; P<0.001; Figure 2 and Figure 3B) FIGURE 2: Percentage of Patients With ≥75% Reduction From Baseline in IGAxBSA (ITT Population) 0% 15% 10% 5% 20% 25% 30% 35% 40% 45% 50% Study Visit (Weeks) P e rc e n ta g e o f P a rt ic ip a n ts Baseline 2 4 6 8 12 Treatment Posttreatment HP/TAZ (n=100) Vehicle (n=63) *P<0.01; **P<0.001 vs vehicle. BSA, body surface area; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent-to-treat. ◾ These HP/TAZ results align closely with those from the apremilast study • Apremilast-treated participants had a 48% mean reduction from baseline in PGAxBSA scores at Week 16 compared with a 10% reduction in placebo-treated participants (P<0.0001; Figure 3A) • The percentage of participants achieving a ≥75% reduction from baseline in IGAxBSA score was 35.1% in the apremilast group versus 12.3% in the placebo group (P<0.001; Figure 3B) FIGURE 3: Indirect Comparison Between HP/TAZ and Apremilast -50% -40% -30% -20% -10% 0% HP/TAZ (n=100) Vehicle (n=63) M e an P e rc e n t C h an g e F ro m B as e lin e Week 8 -46.0% -48.1% -15.7% -10.2% A. Mean Reduction From Baseline in IGAxBSAa or PGAxBSAb (ITT Populations) -50% -40% -30% -20% -10% 0% Apremilast (n=148) Placebo (n=73) Week 16 0% 10% 20% 30% 40% 50% HP/TAZ (n=100) Vehicle (n=63) P e rc e n ta g e o f P ar ti ci p an ts Week 8 33.0% 35.1% 9.5% 12.3% B. Percentage of Patients with ≥75% Reduction in IGAxBSAa or PGAxBSAb (ITT Populations) Apremilast (n=148) Placebo (n=73) Week 16 0% 10% 20% 30% 40% 50% **P<0.001 vs vehicle/placebo. aHP/TAZ pooled phase 3 data. bApremilast data from Strober et al. 2017.5 BSA, body surface area; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent-to-treat; PGA, Physician’s Global Assessment. CONCLUSION ◾ In patients with moderate plaque psoriasis (IGA score of 3 and BSA 5-10%), HP/TAZ lotion provides significantly greater efficacy than vehicle, an effect that was sustained posttreatment ◾ These Week 8 results with HP/TAZ lotion align closely with Week 16 results from a study of the oral psoriasis treatment apremilast in a similar patient population REFERENCES 1. Menter, et al. J Am Acad Dermatol. 2009;60(4):643-659. 2. Gold LS, et al. J Am Acad Dermatol. 2018;79(2):287-293. 3. Sugarman JL, et al. J Drugs Dermatol. 2018;17(8):855-861. 4. Kircik LH, et al. J Drugs Dermatol. 2019;18(3):279-284. 5. Strober B, et al. J Drugs Dermatol. 2017;16(8):801-808. AUTHOR DISCLOSURES Dr. 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. He is a stockholder in Top MD. Dr. Edward Lain has nothing to disclose. Dr. Tina Lin is an employee of Ortho Dermatologics. Dr. Robert Israel is an employee of Bausch Health.