PowerPoint Presentation Figure 1: Study Flow Diagram Poster presented at the 2018 Winter Clinical Dermatology Conference in Maui, HI; January 12-17th, 2018. Real world experience with calcipotriene and betamethasone dipropionate foam 0.005%/0.064% (Cal/BD foam) in the treatment of adult psoriasis itch from retrospective chart review Jashin J. Wu, MD1; Karen A. Veverka, PhD2; Minyi Lu PhD2; and April W. Armstrong, MD3 1Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA; 2LEO Pharma Inc., Madison, NJ; 3Department of Dermatology, Keck School of Medicine of University of Southern California, Los Angeles, CA, USA. Introduction Results Conclusions Materials & Methods Disclosures References  Despite a reported global prevalence of pruritus ranging from 64% to 97%1, the real-world data on the impact of topical medications on itch in psoriasis patients has not been widely reported.  Treatment with the foam formulation of calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam is a topical treatment for chronic adult plaque psoriasis with efficacy and safety established in clinical trials.2-5  We assessed the clinical characteristics, treatment patterns, and other physician and patient characteristics, adverse events, and resource utilizations in patients using Cal/BD foam to treat plaque psoriasis.  The results of our study uniquely provide real-world practice data for topical psoriasis therapy with Cal/BD foam including impact on itch. Study Design  Retrospective, observational, medical chart review conducted at clinical practice sites in US  Psoriasis vulgaris (n=105) patients ≥18 years who initiated Cal/BD foam between Jan 1, 2016 and Oct 31, 2016 were included.  Patients were required to have baseline visit and at least 3 months of available data after treatment initiation, and no history of psoriatic arthritis.  HCPs who abstracted records reported being experienced in treating psoriasis and in prescribing Cal/BD foam, and were balanced for geographical representation. (Figure 1)  The healthcare providers were asked to complete a survey to assess attitudes towards Cal/BD foam. Table 1. Patient Baseline Demographics Patient Demographics  59 men and 46 women; mean age at Cal/BD foam initiation 41.7 years (Table 1)  Most of the patients are White (88%); 9% of Hispanic ethnicity  60% patients diagnosed with psoriasis before Cal/BD foam initiation  91.4% with ≥1 follow-up visit after Cal/BD foam initiation Baseline Disease Characteristics  Patients had a history of plaques affecting knees, n=45 (43%); elbows n=39 (37%); trunk n=30 (29%), lower extremities n=27 (26%), scalp n=24 (22%), and upper extremities n=20 (19%). (Table 2)  The median BSA plus scalp was 5.0% and ranged from 1%-85%. (Figure 2)  45.7% of patients complained of itch and itch affected the quality of life of 60.4% of the patients who experienced itch at baseline. (Table 3)  Clinical measures of disease severity (e.g., PGA, PASI) were not recorded in patient charts and therefore were not available.  Itch is present for an overwhelming majority of mild- moderate patients before initiation of topical treatment.  Itch is a bothersome symptom; 55.2% of patients complained about itch to their provider as was documented in their medical chart, and itch affected quality of life for 60.4% of the patients who complained about itch.  Based on this chart review study, adult psoriasis patients treated topically with Cal/BD foam for up to 4 weeks realized significant improvements in treatment response of plaque lesions. Lesions were ‘clear’ or ‘almost clear’ and with important corresponding reductions of itch.  These data help extend results reported from clinical trials with Cal/BD foam. Table 5. Response of Itch to Cal/BD Foam Treatment Response: Pruritus  Treatment response was also reported for itch. Of the plaques for which the presence of itch was recorded at baseline and time of best response to treatment with Cal/BD foam (Table 5): o 50% of treated areas (n=6+58) had itch at baseline and 50% did not (n=64) o Itch resolved for 90.1% (58/64) of plaques with itch at baseline (i.e., no itch after treatment with Cal/BD foam) o All areas (100%) with no itch at baseline did not have itch after treatment. Safety and tolerability  Adverse events (skin irritation on the knees and the palms/soles) were reported in n = 1/105 (1%) patients in this real-world study. 1. Reich A, Szepietowski JC. Clinical Aspects of Itch: Psoriasis. In: Carstens E, Akiyama T, editors. Itch: Mechanisms and Treatment. Boca Raton (FL): CRC Press/Taylor & Francis; 2014. Chapter 4. Available from: https://www.ncbi.nlm.nih.gov/books/NBK200930/ 2. Paul C et al. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):119-126. 3. Lebwohl M et al. J Clin Aesthet Dermatol. 2016; 9(2): 34-41. 4. Koo J et al. J Dermatol Treat, 2016; 27(2):120-127. 5. Leonardi C et al. J Drugs Dermatol. 2015; 14(12):1468-1477. • Wu JJ and Armstrong AW have been advisors with/without funding to LEO Pharma, Inc. • Lu M and Veverka K are employed by LEO Pharma, Inc. • The analysis of data was conducted by RTI, Inc. and A+A, sponsored solely by LEO Pharma, Inc. • Editorial support provided by Dharm Patel, PhD at LEO Pharma, Inc. Patients (N=105) n (%) Age, years 41.7 Sex Female Male 46 (44%) 59 (56%) Race White Black Asian American Indian or Alaska Native Native Hawaiian or Other Pacific Islander Other Ethnicity Hispanic 92 (88%) 2 (2%) 5 (5%) 0 (0%) 1 (1%) 5 (5%) 9 (9%) Patients (N=105) n (%) History of plaques affecting: Scalp Facial seborrheic Trunk Upper Extremities (excluded: elbows) Elbows Lower extremities Knees Genitals Palms/soles Nails 24 (22%) 5 (5%) 30 (29%) 20 (19%) 39 (37%) 27 (26%) 45 (43%) 3 (3%) 5 (5%) 4 (4%) Table 2. Baseline Disease Characteristics Patients (N=105) n (%) BSA, % 5 (1-85) PGA Not recorded PASI Not recorded Itch 87 (82.6%) Complained of itch 48 (55.2) Table 3. Baseline Disease Characteristics Figure 2. Distribution of BSA Plus Scalp Affected at Cal/BD Foam Initiation Treatment Response: Plaque Areas  There were a total of 177 plaque areas treated with Cal/BD foam in the study.  Cal/BD foam was prescribed to use once-daily (n=124/177 treated plaques; 70.1%) for 4 weeks (n=69/177 treated plaques; 39.0%).  126/177 plaque areas were evaluated for which response could be attributed to Cal/BD foam, and of those, 113 were mild-moderate-severe before treatment initiation. (Table 4)  After treatment with Cal/BD foam:  70.6% of plaques classified as mild/moderate/severe at baseline were ‘clear’ or ‘almost clear’.  55.7% of plaques classified as mild/moderate/severe at baseline were ‘clear’ or ‘almost clear’ with 2-grade improvement. Plaque areas (N = 177) # plaque areas evaluated with response to Cal/BD foam 126 # plaque areas at mild-mod-sev 113/126 # plaque areas at mild-mod-sev that were ‘clear’ or ‘almost clear’ at time of best response 80 # plaque areas at mild-mod-sev that were ‘clear’ or ‘almost clear’ at time of best response with 2 grade improvement 63 Table 4. Response of Plaques to Cal/BD Foam Plaque areas (N=177) Response to Cal/BD foam (n) 128 Itch (n), prior to Cal/BD foam treatment 64/128 No itch (n), prior to Cal/BD foam treatment 64/128 Itch resolved (n), after Cal/BD foam treatment 58 Itch not resolved (n), after Cal/BD foam treatment 6 N = # plaque areas https://www.ncbi.nlm.nih.gov/books/NBK200930/ Slide Number 1