PowerPoint Presentation Psoriasis Patients on Chronic Biologic Therapy May Benefit From Additional Treatment—Study Design and Baseline Characteristics Jerry Bagel, MD; James Zapata; Elise Nelson, LPN, CCRC; and Brian Keegan, MD, PhD Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey Background  More than 50% of patients with psoriasis are dissatisfied with their treatment, including biologic treatment1  Greater disease clearance is desired by patients and is supported by the recent treat-to- target recommendations from the Medical Board of the National Psoriasis Foundation1  Accordingly, patients receiving biologic therapy for psoriasis may benefit from adjunctive therapy with topical agents2,3  Treatment with the foam formulation of calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) as a fixed combination topical product is significantly more effective than calcipotriene or betamethasone monotherapy, and is superior to ointment and gel formulations of Cal/BD4-6  Patients with psoriasis who have been treated with biologic therapy for at least 24 weeks are currently being enrolled in a real-world study designed to assess the efficacy and safety of Cal/BD foam as adjunctive therapy  Described here is the design for this study, as well as the residual disease activity observed in these patients at enrollment Poster presented at the 2018 Winter Clinical Dermatology Conference in Maui, HI; January 12-17, 2018. References 1. Armstrong AW, Bagel J, Van Voorhees AS, et al. JAMA Dermatol. 2015;151(4):432-438. 2. Menter A, Korman NJ, Elmets CA, et al. J Am Acad Dermatol. 2009;60(4):643-659. 3. Bagel J, Stein Gold L. J Drugs Dermatol. 2017;16:1209-1222. 4. Lebwohl M, Tyring S, Bukhalo M, et al. J Clin Aesthet Dermatol. 2016;9(2):34-41. 5. Paul C, Stein Gold L, Cambazard F, et al. J Eur Acad Dermatol Venereol. 2017;31(1):119-126. 6. Leonardi C, Bagel J, Yamauchi P, et al. J Drugs Dermatol. 2015;14(12):1468-1477. Methods  25 adults with psoriasis (body surface area [BSA] ≤5%) being treated with biologic agents for ≥24 weeks have been enrolled in an open-label, single-arm, observational study (Figure 1)  In addition to their biologic therapy, all patients will receive Cal/BD foam QD for 4 weeks, followed by Cal/BD foam on 2 consecutive days weekly for an additional 12 weeks  The end points will be assessed at baseline, week 4, and week 16  Safety evaluations include assessments of local skin reactions and adverse events (AEs) QD on 2 consecutive days per weekQD Baseline 4 8 16 Weeks Population and Key Inclusion Criteria • N=25 • Adults with chronic plaque psoriasis • ≥24 weeks biologic therapy • BSA ≤5% Prescribed biologic therapy regimen plus Cal/BD foam (0.005%/0.064%) Assessments 12 Figure 1. Study Design End Points Physician’s Global Assessment (PGA), BSA, PGA x BSA, Dermatology Life Quality Index (DLQI), and the Treatment Satisfaction Questionnaire for Medication (TSQM)-9 Demographics  18 men and 7 women; mean age, 53 years (Table 1)  Most of the patients are Caucasian (84%), with the remaining patients being Hispanic (16%)  On average, patients have had a 24-year history of psoriasis Patients (N=25) Age, years 53 (11) Sex Female Male 7 (28%) 18 (72%) Race Caucasian Hispanic 21 (84%) 4 (16%) Years of psoriasis 24 (13) Data are mean (IQR) or n (%). Table 1. Baseline Demographics Disease Characteristics  Approximately half of the patients are being managed with ustekinumab as their biologic agent (Table 2)  At enrollment, the patients were experiencing psoriasis disease activity that warranted either adding therapy or switching to a different biologic agent o Based on PGA, BSA, and PGA x BSA scores o Only 3 patients (12%) met the treat-to-target criterion of BSA ≤1% Patients (N=25) Biologics in use at baseline Ustekinumab Adalimumab Secukinumab Etanercept Ixekizumab 13 (52%) 5 (20%) 5 (20%) 1 (4%) 1 (4%) PGA 3 (2-3) BSA, % 3 (2-4) PGA x BSA 8 (6-12) Table 2. Baseline Disease Characteristics Data are median (SD) or n (%). IQR=interquartile range, representing the range of values between the 25th and 75th percentiles of the study population. Conclusions  This study reveals that despite ≥24 weeks of stable biologic therapy for psoriasis, significant disease activity remains in this unique, real-world patient population, highlighting an unrecognized, unmet medical need  Residual disease activity was demonstrated by several measures, including scores up to 4 for PGA, 5 for BSA, and 16 for DLQI  Patients with psoriasis desire disease clearance. The disease activity experienced by the patients in this study warrants additional treatment to better control the disease  The itching, burning, and dryness experienced by the majority of the patients compromised their quality of life  The effect of Cal/BD foam in clearing residual disease activity for this unique patient population on stable biologic therapy is being investigated in this study  This study will help to better elucidate the disease characteristics and optimal management of this patient population Quality of Life and Lesion Description  The health-related quality of life of the patients continues to be affected by psoriasis despite ≥24 weeks of biologic therapy, as indicated by their DLQI scores (Table 3)  Itching and burning/stinging of the psoriatic lesions is present in the majority of the patients  40% of the patients experience dryness in their lesions, as observed by the investigator  None of the patients had skin atrophy, striae, telangiectasiae health-related quality of life of the patients, or folliculitis at baseline Patients (N=25) DLQIa 3 (1-4) Psoriasis itching score ≥1a 17 (68%) Psoriasis burning/stinging score ≥1a 5 (20%) Psoriasis dryness score ≥1b 10 (40%) Table 3. Baseline Observations Data are median (IQR) or n (%). aAs reported by the patient. bAs observed by the investigator. Acknowledgments and Disclosures This study was supported by LEO Pharma Editorial support was provided by p-value communications Dr. Bagel is an advisor, consultant, investigator, and speaker for AbbVie, Amgen, Celgene, Janssen, Eli Lilly, LEO Pharma, Novartis, and Regeneron; he is an investigator and consultant for Pfizer and an investigator for Valeant, Lycera, UCB, and Actelion; he is Founder of Windsor Dermatology Dr. Keegan is an investigator and speaker for AbbVie, Janssen, Eli Lilly, Novartis, Pfizer, Actelion, and Valeant and a speaker for Allergan and Promius Slide Number 1