• Topical therapies are the first-line treatment for mild-to-moderate psoriasis or in combination with other therapies for severe disease.1 • Compliance to topical therapies is a significant problem, with adherence rates of just 40-70%.2 • Among other factors, it has been shown that patients’ attitudes toward both psoriasis and its treatment influence compliance.3 • The PSO-INSIGHTFUL study was designed to assess patient- reported factors that influence preference following once-daily topical treatment with Cal/BD foam and gel. The SABA questionnaire was developed with the aim to gain insight into how patients’ lives were impacted by psoriasis, and their attitudes to psoriasis and psoriasis treatments.4 Results of Subject’s Assessment of Behavior and Attitudes (SABA) survey toward psoriasis and treatments in the PSO-INSIGHTFUL study All patients (n=212) Age category, n (%) 18–39 years 48 (22.6) 40–59 years 92 (43.4) ≥60 years 72 (34.0) Male:female, n (%) 133:79 (63:37) BMI, n (%) <25 kg/m2 37 (17.5) 25–30 kg/m2 73 (34.4) >30 kg/m2 102 (48.1) PGA, n (%) Mild 61 (28.8) Moderate 122 (57.5) Severe 29 (13.7) Duration of psoriasis, n (%) <2 years 4 (1.9) 2–5 years 30 (14.2) >5 years 178 (84.0) BSA, n (%) <4% 93 (43.9) 4–6% 56 (26.4) 6–11% 38 (17.9) 11–15% 11 (5.2) ≥15% 14 (6.6) mPASI, n (%) 2–5 86 (40.6) 5.1–10 91 (42.9) >10 35 (16.5) Mean DLQI 7.8 Localized:widespread distribution of psoriasis, % 62:38 BACKGROUND • PSO-INSIGHTFUL was a prospective, multicenter, Phase IIIb, open-label, randomized, two-arm crossover study including patients ≥18 years with mild-to-severe psoriasis of ≥6 months’ duration involving 2-30% BSA and mPASI of ≥2. [NCT02310646] • After 4-week washout, 213 patients were randomized 1:1 to once- daily Cal/BD foam for 1 week, followed by Cal/BD gel for 1 week, or vice-versa. • Patients completed 6 questionnaires at different time periods evaluating patient preferences, one of which was a LEO-created survey titled the Subject’s Assessment of Behavior and Attitudes (SABA) questionnaire, following randomization. The SABA questionnaire (13 questions) • 6 yes/no questions on “impact of psoriasis” • 7 questions on “attitudes to psoriasis and treatments” using a 5- point scale (-2 to +2) • NOTE: more detail on questionnaires available at clinicaltrials.gov. Statistical analyses • Full analysis set (FAS) comprised all randomized patients who completed an on-study questionnaire (212 patients). RESULTS DISCUSSION Table 1. Patient Demographics at Baseline BMI, body mass index; BSA, body surface area; mPASI, modified psoriasis and severity index; PGA, Physician’s Global Assessment of disease severity Impact of Psoriasis Yes, n (%) No, n (%) N/A, n (%) Psoriasis impacts on my work 56 (26.4) 115 (54.2) 41 (19.3) Psoriasis impacts on my social life 105 (49.5) 107 (50.5) 0 Psoriasis impacts on my relationships/sex life 73 (34.8) 137 (65.2) 0 Psoriasis has a physical impact on my life 85 (40.1) 127 (59.9) 0 Psoriasis impacts on my self confidence 125 (59.0) 87 (41.0) 0 Psoriasis impacts on my emotional well being 112 (53.1) 99 (46.9) 0 Attitudes to Psoriasis and Treatments Strongly/slightly agree, n (%) Neither agree nor disagree, n (%) Strongly/slightly disagree, n (%) I prefer my doctor to recommend the best treatment rather than offering me different options and letting me decide 159 (75.4) 18 (8.5) 34 (16.1) I regularly seek out information about psoriasis 145 (68.7) 27 (12.8) 39 (18.5) I am keen to try the newest treatments available 189 (90.0) 12 (5.7) 9 (4.3) Being able to apply treatment quickly is very important to me 190 (90.1) 15 (7.1) 6 (2.8) I have a busy lifestyle that limits time for treatment 111 (52.6) 41 (19.4) 59 (28.0) I worry about the side effects of treatment 123 (58.2) 34 (16.1) 54 (25.6) I feel very self-conscious about psoriasis 134 (63.8) 33 (15.7) 43 (20.4) Table 2. Patient SABA Responses • PSO-INSIGHTFUL was conducted in EU and Canada; no US subjects participated in the study. • SABA responses should be interpreted in the context of the PSO-INSIGHTFUL study due to utilization of a LEO-designed survey. • Statistical analysis was not performed for responses to SABA questionnaire; adjustments with baseline patient characteristics or treatment arm were not made. • No specific analyses of different responses based on patient characteristics (age, gender, severity of disease) was conducted. • Fewer patients agreed with the statements “I have a busy lifestyle that limits time for treatment” (52.6%) and “I worry about the side effects of treatment” (58.2%) as compared to the majority of patients whom agreed with statements “being able to apply treatment very quickly is very important to me” (90.1%) and “I am keen to try the newest treatments available” (90.0%). • Psychosocial impairment is highly heterogeneous across populations of psoriasis patients; the results of this survey only speak to the population in this study since the SABA questionnaire is not a validated survey. • While these supplementary data provide insight into patient attitude and behavior toward psoriasis and treatments, more research is necessary to obtain a complete understanding of the data presented. References 1. Nast A, Gisondi P, Ormerod AD, et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris--Update 2015--Short version--EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol 2015;29:2277–94. 2. Devaux S, Castela A, Archier E, et al. Adherence to topical treatment in psoriasis: a systematic literature review. J Eur Acad Dermatol Venereol 2012;26(Suppl 3):61–67. 3. Feldman SR, Horn EJ, Balkrishnan R, et al. Psoriasis: Improving adherence to topical therapy. J Am Acad Dermatol 2008;59(6);1009-1016. 4. Hong C-H, Papp KA, Lophaven KW, et al. Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: Randomized Phase IIIb PSO-INSIGHTFUL study [submitted]. Douglas DiRuggiero, MHS, PA-C1; Chih-Ho Hong, MD2; Lisa Tiu, PharmD3; Scott Freeman, PA-C4 Figure 1. PSO-INSIGHTFUL Study Design CONCLUSION • Results from the SABA questionnaire in the PSO-INSIGHTFUL study show that fewer patients reported psoriasis impacts interpersonal relationships (work and sex life), while more than half of patients reported psoriasis has a personal impact on their lives (self confidence and emotional wellbeing). • Overall, SABA responses indicate patients’ attitudes toward specific aspects of psoriasis treatment (i.e., quick treatment application, willingness to try newest treatments) are stronger than their worry of side effects or self- perception of lifestyles that limit time for treatment. • While these supplementary data provide insight into patient attitude and behavior toward psoriasis and treatments, more research is necessary to obtain a complete understanding of the data presented. Impact of Psoriasis • About half of patients reported that psoriasis has an impact on self confidence (59.0%), emotional well being (53.1%), and social life (49.5%). • Responses indicate that psoriasis also impacts work (26.4%), relationships/sex life (34.8%), and physical aspects (40.1%) of the lives of surveyed individuals. Attitudes to Psoriasis and Treatments • More patients preferred that their doctors recommend the best treatment rather than being offered different options (75.4%) and/or regularly seek out information about psoriasis (68.7%). • Majority of patients agreed with the statements “being able to apply treatment very quickly is very important to me” (90.1%) and “I am keen to try the newest treatments available” (90.0%). • Approximately half of patients agreed with the statements “I have a busy lifestyle that limits time for treatment” (52.6%) and “I worry about the side effects of treatment” (58.2%). • More patients reported that they feel self-conscious about psoriasis (63.8%) than not (20.4%). METHODS LIMITATIONS Acknowledgements: Funding for research provided by LEO Pharma A/S. Editorial support provided by LEO Pharma Inc. Poster originally presented at Maui Derm NP+PA Summer 2017; June 14-17, 2017; Colorado Springs, CO. 1Rome Dermatology Center, Rome, GA; 2University of British Columbia, Department of Dermatology and Skin Science and Probity Medical Research, Surrey, Canada; 3LEO Pharma Inc., Madison, NJ; 4Advanced Dermatology, St. Petersburg, FL FC17PosterLEODiRuggieroResultsofBehaviorAssessment.pdf