Figure 3. Percent of patients receiving HP/TAZ who achieved sIGA clear or almost clear. HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; sIGA, scalp Investigator’s Global Assessment.6 Figure 4. Percent of patients achieving PSSI 75, 90, and 100 at conclusion of HP/TAZ therapy (8 weeks) and at 4-week follow-up (12 weeks). HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; PSSI, Psoriasis Scalp Severity Index.6 • In both studies, HP/TAZ was well tolerated5,6 – There were no reported instances of skin atrophy, striae, telangiectasia, or folliculitis in the scalp psoriasis study – Only application site dermatitis (n=3) was reported in the palmoplantar psoriasis study Scalp Psoriasis Study6 • In a single-center, open-label pilot study, adult participants who had moderate-to-severe psoriasis with scalp involvement (N=21) applied HP/TAZ once daily for 8 weeks and were followed for 4 weeks posttreatment (week 12; N=20) • The primary endpoint was proportion of participants with an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at week 8 • Other outcomes included 75%/90%/100% improvement in Psoriasis Scalp Severity Index (PSSI 75/90/100, respectively) and scalp IGA (sIGA) improvement RESULTS • In the palmoplantar study, mean ppPGA scores improved significantly with HP/TAZ treatment from baseline to week 24 (P=0.0165; Figure 2)5 Figure 2. Improvements in Palmoplantar Physician Global Assessment from baseline to week 24 in patients receiving HP/TAZ. HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; LOCF, last observation carried forward.5 • At week 8 in the scalp psoriasis study6: – 10/21 patients (48%) achieved a score of IGA 0 or 1 – 15/21 patients (>70%) achieved an sIGA score of 0 or 1, and 50% maintained these scores at week 12 (Figure 3) – Nearly one-third of patients (29%) had sIGA 0, and 20% maintained sIGA 0 at week 12 • Significant improvements from baseline in PSSI 75 rates were observed at weeks 4, 8, and 12 (P≤0.0005 for all) • Rates of PSSI 75/90/100 were maintained from week 8 to 12 (Figure 4) – PSSI 75: 67% of patients achieved PSSI 75 at week 8, with 45% maintaining at week 12 – PSSI 90: 38% of patients achieved PSSI 90, with 30% maintaining at week 12 – PSSI 100: 29% of patients achieved PSSI 100, with 20% maintaining at week 12 OBJECTIVE • To review previously published results from open- label studies of HP/TAZ in palmoplantar psoriasis and scalp psoriasis in the context of reduction of proinflammatory mediators such as TNF-α CONCLUSION • The inhibition of TNF-α by HP/TAZ could potentially contribute to the effectiveness of HP/TAZ in psoriasis lesions involving difficult-to- treat areas SYNOPSIS • Tumor necrosis factor α (TNF-α) plays a key role in the pathogenesis of psoriasis and is a target of systemic therapies1 – Systemic TNF-α inhibitors have been shown to be efficacious against difficult-to-treat areas of psoriasis2 • A recent study showed that fixed-combination halobetasol propionate 0.01%/tazarotene 0.045% lotion (HP/TAZ) substantially reduced TNF-α levels in psoriatic plaques at weeks 2 through 12 of treatment compared with levels in untreated plaques (Figure 1)3 Figure 1. TNF-α levels in plaques treated with HP/TAZ vs untreated plaques across 12 weeks.3 TNF-α, tumor necrosis factor alpha. • The additive effect of HP and TAZ on reduction of proinflammatory mediators such as TNF-α4 may improve outcomes in difficult-to-treat areas, such as the palms, soles of the feet, and scalp – The combined benefits of HP/TAZ could result from nonoverlapping immunogenetic mechanisms of HP and TAZ4 – Additionally, TAZ may mitigate the risk of skin atrophy associated with prolonged topical corticosteroid use4 METHODS Palmoplantar Psoriasis Study5 • In an investigator-initiated, open-label study, adult participants with moderate-to-severe palmoplantar psoriasis (N=17) were treated once daily with HP/TAZ for 24 weeks – Psoriasis severity was assessed by the Palmoplantar Physician Global Assessment (ppPGA), with a score of 0 indicating “clear” and a score of 5 indicating “severe” – ppPGA was assessed at baseline and again at week 24 Use of Combination Halobetasol Propionate/Tazarotene Lotion in Difficult-to- Treat Psoriasis and TNF-α Mechanism of Action Leon Kircik,1 Zoe Draelos,2 Linda Stein Gold,3 Abby Jacobson4 1Icahn School of Medicine at Mount Sinai, New York, NY; 2Dermatology Consulting Services, PLLC, High Point, NC; 3Henry Ford Health System, Detroit, MI; 4Ortho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ Presented at Winter Clinical Dermatology Conference® • January 13-18, 2023 • Kohala Coast, HI Sponsored by Ortho Dermatologics, a division of Bausch Health US, LLC. 0 2 4 8 12 -2 0 2 4 8 6 10 12 Week; 0 = BL T N F- α, p g/ m L Treated Untreated Control TNF-α 0 1 2 4 3 5 6 Baseline (Week 0) Week 24/LOCF Pa lm o pl an ta r Ph ys ic ia n G lo ba l A ss es sm en t Mean=2.82 Mean=3.47 52 71 50 0 20 40 60 80 100 Week 4 Week 8 Week 12 (Posttreatment) Pa ti en ts , % sIGA (Absent or Very Mild) 67 45 38 3029 20 0 20 40 60 80 100 Week 8 Week 12 Pa ti en ts ,% PSSI 75 PSSI 90 PSSI 100 Funding: This study was supported by Ortho Dermatologics. Editorial assistance was provided under the direction of the authors by MedThink SciCom. Previous presentation information: Data in this poster have been published previously (Ozyurekoglu and Kircik. J Drugs Dermatol. 2021;20:1191-1194) and were presented at the 2022 American Academy of Dermatology Annual Meeting; March 25-29, 2022; Boston, MA, and at the Fall Clinical Dermatology Conference; October 20-23, 2022; Virtual and Las Vegas, NV. References: 1. Chima and Lebwohl. Semin Cutan Med Surg. 2018;37:134-142. 2. Lanna et al. Dermatol Ther. 2020;33:e13374. 3. Draelos et al. Presented at: FCDC 42nd Annual Fall Clinical Dermatology Conference; October 20-23, 2022; Virtual and Las Vegas, NV. 4. Lebwohl et al. Dermatol Ther (Heidelb). 2021;11:1157-1174. 5. Campbell et al. Presented at: American Academy of Dermatology Annual Meeting; March 25-29, 2022; Boston, MA. 6. Ozyurekoglu and Kircik. J Drugs Dermatol. 2021;20:1191-1194. Author disclosures: LK has served as an investigator, speaker, advisory board member, or consultant for Abbott Laboratories; Aclaris, Inc; Allergan, Inc; Amgen Inc; Anacor Pharmaceuticals, Inc; Assos Pharma; Astellas Pharma US, Inc; Asubio Pharma Co, Ltd; Berlex Laboratories (Bayer Healthcare Pharmaceuticals); Biogen-Idec, Inc; Biolife; Biopelle; Boehringer Ingelheim; Breckin- ridge Pharma; Celgene Corporation; Centocor, Inc; Colbar; CollaGenex; Combinatrix; Connetics Corporation; Coria; Dermik Laboratories; Dermira, Inc; Dow Pharmaceutical Sciences, Inc; Dusa Pharmaceuticals, Inc; Eli Lilly & Co; Embil Pharmaceutical Co, Ltd; EOS; Ferndale Laboratories, Inc; Galderma Laboratories, LP; Genentech, Inc; GlaxoSmithKline, PLC; Health Point Ltd; Idera, Inc; Innocutis Medical, LLC; Innovail; Intendis, Inc; Johnson & Johnson; Laboratory Skin Care, Inc; Leo Pharmaceuticals, Inc; L’Oreal SA; 3M; Maruho Co, Ltd; Medical International Technologies; Medicis Pharmaceutical Corp; Merck & Co, Inc; Merz; Nano Bio Corporation; Novartis Pharmaceutical Corporation; Noven Pharmaceuticals, Inc; Nucryst Pharmaceuticals Corporation; Obagi Medical Products, Inc; Onset; OrthoNeutrogena; PediaPharma, Inc; Promius Pharma, LLC; PharmaDerm; Pfizer, Inc; PuraCap; QLT, Inc; Quatrix; Quinnova; Serono (Merck-Serono International SA); SkinMedica, Inc; Stiefel Laboratories, Inc; Sun Pharmaceutical Industries, Ltd; Taro; TolerRx, Inc; Triax; UCB, Inc; Valeant Pharmaceuticals North America LLC; Warner-Chilcott; XenoPort, Inc; and ZAGE. ZD received funding from Ortho Dermatologics to conduct the research detailed in the poster. LSG has served as an investigator/advisor and/or speaker for Almirall, Galderma, Ortho Derm, Sun, Novartis, Sol Gel, and Vyne. AJ is an employee of Ortho Dermatologics (a division of Bausch Health US, LLC). Presenting Author: Leon Kircik; wedoderm@yahoo.com