Patient Tolerability of tazarotene foam, 0.1%, and Impact on Patient Compliance Real World Patient Perceptions of the use of Calcipotriene Foam 0.005% in the Treatment of Plaque Psoriasis Francisco Kerdel, MD, FAAD;a Christina Don PA, MCMSc;b Renata Block PA-C, MMS; Caitlin Lewis, PhD;c Rhonda Schreiber MSRNd CONCLUSIONS METHODS RESULTSINTRODUCTION Participants were asked “How satisfied are you with the improvement in psoriasis you’ve seen in the areas you have treated with calcipotriene foam, 0.005%?”. The responses from the final survey, after 8 weeks on therapy, are shown in the chart to the left. • Patient satisfaction levels are strong across both genders and all ages with no significant difference in any one group. • Satisfaction in the severity of psoriasis cohort increases as the BSA affected increases. • Patients who treated their scalp only were most satisfied (85%), followed by those treating both the body and scalp (78%), and then body alone (70%). • Patients who used the product as a monotherapy were more satisfied (79%) than those who used it in combination with other therapies (72%). AFFILIATIONS AND DISCLAIMERSREFERENCES 1. Gupta R, Debbaneh MG, Liao W, Genetic Epidemiology of Psoriasis,. Curr Dermatol Rep. 2014 March; 3(1):61-78. 2. Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Investig Dermatol Symp Proc. 2004 Mar;9(2):136-9. 3. Tan X, Feldman SR, Chang J, Balkrishnan R. Topical drug delivery systems in dermatology: a review of patient adherence issues. Expert Opin Drug Deliv. 2012 Oct;9(10):1263-71. 4. Stein Gold LF. Topical Therapies for Psoriasis: Improving Management Strategies and Patient Adherence. Semin Cutan Med Surg. 2016 Mar;35(2 Suppl 2):S36-44; quiz S45. 5. Del Rosso JQ, Kircik LH, Zeichner J, Stein Gold L. The Clinical Relevance and Therapeutic Benefit of Established Active Ingredients Incorporated into Advanced Foam Vehicles: Vehicle Characteristics Can Influence and Improve Patient Outcomes J Drugs Dermatol. 2019 Feb 1;18(2s):s100-s107. 6. Eastman WJ, Malahias S, Delconte J, DiBenedetti D. Assessing attributes of topical vehicles for the treatment of acne, atopic dermatitis, and plaque psoriasis. Cutis. 2014 Jul;94(1):46-53. 7. Feldman , S. R., Mills, M., Brundage, T., & Eastman, W. J. (2013, March). A multicenter, randomized, double-blind study of the efficacy and safety of calcipotriene foam, 0.005%, vs vehicle foam in the treatment of plaque-type psoriasis of the scalp. JDD, 12(3), 300-306. 8. Data on File, Mayne Pharma, Inc. PARTICIPANT DEMOGRAPHICS 37 37 37 36 37 44 30 36 32 40 40 32 46 37 39 34 39 39 38 45 37 34 42 38 42 36 40 38 39 41 40 38 0 10 20 30 40 50 60 70 80 90 100 P e rc e n t o f R e sp o n d e n ts Overall Satisfaction at Week 8 (n=276) Very Satisfied Satisfied Age Severity of Psoriasis Location of Use Use of Treatment 81% 74% 78% 72% 74% 74% 76% 80% 70% 85% 78% 79% 72% *% at the top of the bars = respondents who were either satisfied or very satisfied Total Respondents to Week 8 Survey n=276 n(%) Gender Male 102 (37) Female 172 (62) Other 2 (1) Age 18-30 55 (20) 31-40 67 (24) 41-50 62 (22) 51-60 50 (18) 61+ 42 (15) Race Caucasian 221 (80) African American 14 (5) Hispanic/Latino 19(7) Asian 11 (4) Other 11 (4) Severity of Psoriasis %BSA Less than 3% 110 (40) Between 3-10% 121 (44) More than 11% 45 (16) Location of Treatment Body only 134 (49) Scalp Only 71 (26) Body and Scalp 71 (26) Use of Treatment Used alone 162 (59) Used in combination 114 (41) Gender • Participants were asked “Has your itch improved since starting calcipotriene foam, 0.005%? If yes, how improved?” • At Week 8, 71% of participants reported an improvement in itch • 60% reported moderate or strong improvement. 29% 37% 23% 11% 71% Perceived Improvement in Itch at Week 8 (n=276) Very improved Moderately improved Slightly improved 26 57 65 61 59 70 57 59 42 28 25 29 30 25 33 30 25 12 7 7 8 5 8 9 0 20 40 60 80 100 P e rc e n t o f R e sp o n d e n ts Product Attribute Rating (n=276) Excellent Good Fair 68% 85% 80% 91% 89% 95% 90% 89% *% at the top of the bars = sum of excellent and good YESNO DISCUSSION 62 11 12 7 8 0 10 20 30 40 50 60 70 Foam Solution Cream Lotion Ointment P e rc e n t o f R e sp o n d e n ts Preferred Treatment Formulation (n=276) Patients were invited to upload photographic evidence to illustrate their treatment progress over the 8 week period. This patient, a Caucasian male, aged 62, was using calcipotriene foam, 0.005% on his body only, as a monotherapy. The reduction in visible plaque is clearly apparent. This patient was “Very Satisfied” at weeks 4 and 8. Registration Week 2 Week 4 Week 8 Psoriasis is a common chronic immune-mediated inflammatory disease of the skin, with approximately 150,000 newly diagnosed patients in the United States each year.1 Most patients report their disease has significant physical and psychosocial impact on their lives and non-adherence to topical psoriasis treatment has been correlated to patient perception of vehicle attributes and negative treatment outcomes.2-6 Calcipotriene foam, 0.005% is the only steroid-free vitamin D3 analog approved for use in a foam vehicle and has proven safety and efficacy as a monotherapy.7 Patient questionnaires administered during the calcipotriene foam, 0.005%, Phase III trials reported positive patient perceptions of the foam vehicle and therapeutic outcomes in psoriasis. These positive results in a controlled setting prompted a series of surveys to current users of calcipotriene foam, 0.005% to gather patient perspectives on its use in “real world” clinical practice. • A total of 276 participants completed the final survey at week 8 with diversity across gender, age, race, and severity of psoriasis. • The severity of patients’ psoriasis was described as % of Body Surface Area (%BSA), where less than 3% can be considered mild, 3-10% moderate, and >11% as severe. • Participants were also asked which areas of their body they were treating and whether they were using the product alone or in combination with other treatments. • Participants were asked to rate a number of attributes of calcipotriene foam 0.005% in the 8 week survey and rated all very strongly. • When asked to rank the different topical formulations in order of preference, foam was clearly the most preferred option with 62% of participants ranking it number one. • The next most preferred formulation was cream (12%), then solution (11%). METHODS The completed surveys represent a significant sample size with diversity across gender, race and age. The foam formulation was preferred by the majority of participants, who rated all vehicle attributes very highly. Patients perceived the treatment as effective and submitted photographic evidence to support this. Overall calcipotriene foam, 0.005% was rated by patients as an effective and easy to use topical treatment for psoriasis. The results of these surveys support the Phase III clinical trial questionnaire results and point to a high likelihood for compliance with treatment regimens which include calcipotriene foam, 0.005%. 276 patients completed the final survey at Week 8, with 76% either satisfied or very satisfied with the improvement in psoriasis they saw with the product. At Week 8 the highest satisfaction rates were reported by the following subsets: those using calcipotriene foam, 0.005% on their scalp alone (85%), those with severe psoriasis (>11% BSA) (80%), and those using using the product as monotherapy (79%). Satisfaction did not differ significantly by gender (76% for males and 75% for females) and no trend was seen across age groups (between 72-81%). Additionally, after using the foam for 8 weeks, 73% of participants indicated they were likely or very likely to continue use of the product, and 79% indicated they would be likely or very likely to recommend the product to a friend or family member.8 All vehicle attributes rated highly and patients showed a very strong preference for the foam vehicle in comparison to other formulations. 76% 76% 75% a. Dermatology Residency Program at the LECOMT/Larkin Community Hospital, Palm Springs Campus, Hialeah, Florida; Florida Academic Dermatology Center, Coral Gables, Florida; Florida International University, Miami, Florida. b. Florida Academic Dermatology Center, Coral Gables, Florida; c. Clewy Communications, Raleigh, NC; d. Mayne Pharma, Greenville, NC. These surveys and analysis were supported by Mayne Pharma. • Patients with plaque psoriasis who were being treated with calcipotriene foam, 0.005%, were asked to rate their experiences using the product over the course of 8 weeks. • Surveys were administered at registration and then weeks 2, 4 and 8 to gather feedback on patient satisfaction with the product, perceived improvement in symptoms and itch, vehicle attributes, and topical vehicle preference. • Patients completed surveys within 3 days to ensure feedback was gathered at the specific time points. • Patients were also invited to submit photographs to show their treatment progress.