Patient Tolerability of tazarotene foam, 0.1%, and Impact on Patient Compliance Patient Perception of Vehicle and How This Influences Adherence to Topical Treatment Regimens Steven R. Feldman MD, FAAD; Rhonda Schreiber BSN, MS; Kaytiana Crane BS; Madelyn Comito Difficulties with patient adherence to previously available topical formulations of calcipotriene are well documented and prescribers have long sought ways to improve patient compliance with prescribed treatment regimens. Patients have positive perceptions of the foam vehicle attributes, strong preference for the foam vehicle compared to previously tried medications, and a 22% greater reported likelihood of complying with prescribed treatment where foam is included. The foam vehicle may lead to better compliance and outcomes for patients suffering from psoriasis. REFERENCES: 1. Wolf-Henning Boehncke, Michael P Schön. Lancet 2015; 386: 983–94. Published Online May 27, 2015. http://dx.doi.org/10.1016/S0140-6736(14)61909-7. 2. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB,et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009 Apr;60(4):643-59. 3. Eastman WJ, Malahias S, Delconte J, DiBenedetti D. Cutis. 2014 Jul;94(1):46-53. 4. Data on file; Mayne Pharma. DISCLOSURES: Dr. Feldman is a paid consultant at Mayne Pharma. Mrs. Schreiber, Ms. Crane, and Ms. Comito are employees of Mayne Pharma. This presentation was sponsored by Mayne Pharma • Two identically designed, 8-week, blinded, multicenter, parallel group clinical trials were conducted with 659 subjects with mild to moderate plaque-type psoriasis randomized in a 2:1 ratio to topical calcipotriene foam, 0.005%, (n=437) or vehicle foam (n=222) • Subjects ≥ 12 years with mild to moderate plaque psoriasis involving 2-20% of body surface areas (BSA) • Foam was applied morning and evening or 8 weeks to lesions on the body, using the smallest amount of the product required to completely cover all lesions • Lesions of the scalp or face were excluded • At the final study visit a patient questionnaire was administered regarding formulation attributes, preference for treatment vehicle, and intent to adhere to treatment instructions • Questionnaire results from both Phase III trials have been integrated for analysis and presentation here CONCLUSIONS METHODS RESULTS 58% 29% 59% 29% 5… 27% 58% 28% 59% 29% 59% 30% 59% 26% 39% 16% 0% 10% 20% 30% 40% 50% 60% 70% PERCENT OF PATIENTS RATING FOAM ATTRIBUTES AS EXCELLENT OR GOOD EXCELLENT GOOD FAIR POOR VERY POOR 49% 27% 46% 22% 42% 20% 40% 20% 32% 13% 0% 10% 20% 30% 40% 50% 60% 70% PERCENTAGE OF PATIENTS WHO RATED THE FOAM VEHICLE AS BETTER AND MUCH BETTER THAN PREVIOUSLY TRIED MEDICATIONS MUCH BETTER BETTER ABOUT THE SAME WORSE MUCH WORSE • Psoriasis can lead to long lasting psychological, social, and physical complications. • The majority of cases can be treated with topical therapies, however poor adherence negatively impacts treatment success.2,3 • Vehicle attribute influence adherence.3 • Calcipotriene foam, 0.005%, is a safe and effective steroid-free vitamin D3 analog for plaque psoriasis of the scalp and body.4 • We assessed patient preference for attributes of both active and vehicle foams and how these preferences impacted patient intentions to comply with prescribed treatment plans. INTRODUCTION If you were asked by your doctor to put medicine on your skin everyday including each morning and night for 8 weeks, how likely would you be to follow these instructions? The foam was rated the highest compared to the other vehicles, with 86% of study participants stating that they would comply between 75-100% of the time over an 8 week treatment course. The foam rated 22% higher than the next highest rated vehicle. Please rate the foam on each of the following; easy to apply, spreadability, absorbs quickly, lack of stickiness, fragrance free, does not feel greasy, lack of residue, and moisturizing: Both the active foam and vehicle rated excellent or good with greater than 80% of subjects on all formulation and application attributes, except moisturizing, where 55% of subjects rated the foam as excellent or good. Please rate the following qualities of the foam, compared to the other skin medicines you have used in the past: 77% of subjects had used creams previously, 68% had used ointments, 53% lotions, 42% gels, and 39% had used solutions previously. The foam vehicle rated strongly overall in all qualities and the active calcipotriene, 0.005%, foam ranked consistently better than the foam vehicle alone 86% 64% 51% 47% 32% 31% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Foam Cream Ointment Lotion Solution Gel PREDICTED COMPLIANCE RATE >75% FOR 8 WEEKS INTEGRATED INTENT TO TREAT ANALYSIS N=659, n(%) 100% 75-99% 50-74% 25-49% < or = 24% Foam 384 (58) 180 (27) 19 (3) 3 (<1) 10 (2) Cream 217 (33) 208 (32) 81 (12) 16 (2) 8 (1) Ointment 172 (26) 162 (25) 92 (14) 43 (7) 18 (3) Gel 119 (18) 88 (13) 62 (9) 29 (4) 384 12 (2) Lotion 153 (23) 156 (24) 40 (6) 21 (3) 4 (1) Solution 122 (19) 86 (13) 51 (8) 16 (2) 8 (1) INTEGRATED INTENT TO TREAT ANALYSIS N=659, n(%) EASY TO APPLY EXCELLENT GOOD FAIR POOR VERY POOR Calcipotriene Foam 0.005% 263 (40) 120 (18) 26 (4) 6 (1) 2 (<1) Vehicle Foam 132 (20) 58 (9) 14 (2) 5 (1) 1 (<1) SPEADABILITY Calcipotriene Foam 0.005% 283 (43) 106 (16) 23 (3) 2 (<1) 1 (<1) Vehicle Foam 135 (20) 59 (9) 11 (2) 3 (<1) 0 (0) ABSORBS QUICKLY Calcipotriene Foam 0.005% 228 (35) 140 (21) 31 (5) 14 (2) 3 (<1) Vehicle Foam 115 (17) 64 (10) 25 (4) 6 (1) 0 (0) LACK OF STICKINESS Calcipotriene Foam 0.005% 259 (39) 123 (19) 22 (3) 3 (<1) 3 (<1) Vehicle Foam 127 (19) 60 (9) 13 (2) 3 (<1) 2 (<1) FRAGRANCE FREE Calcipotriene Foam 0.005% 287 (44) 99 (15) 17 (3) 0 (0) 0 (0) Vehicle Foam 145 (22) 47 (7) 14 (2) 1 (<1) 0 (0) DOES NOT FEEL GREASY Calcipotriene Foam 0.005% 263 (40) 125 (19) 21 (3) 5 (1) 3 (<1) Vehicle Foam 130 (20) 69 (10) 8 (1) 2 (<1) 1 <1) LACK OF RESIDUE Calcipotriene Foam 0.005% 209 (32) 140 (21) 54 (8) 11 (2) 3 (<1) Vehicle Foam 91 (14) 80 (12) 26 (4) 8 (1) 4 (1) MOISTURIZING Calcipotriene Foam 0.005% 100 (15) 158 (24) 115 (17) 28 (4) 14 (2) Vehicle Foam 31 (5) 73 (11) 64 (10) 27 (4) 8 (1) INTEGRATED INTENT TO TREAT ANALYSIS N=659, n(%) DISAPPEARS QUICKLY AFTER APPLICATION MUCH BETTER BETTER ABOUT THE SAME WORSE MUCH WORSE CALCIPOTRIENE 0.005% FOAM 215 (33) 112 (17) 49 (7) 20 (3) 5 (1) VEHICLE FOAM 103 (16) 72 (11) 20 (3) 8 (1) 3 (<1) EASILY APPLIES TO LARGE BSA CALCIPOTRIENE 0.005% FOAM 182 (28) 121 (18) 62 (9) 7 (1) 4 (1) VEHICLE FOAM 85 (13) 59 (9) 38 (6) 7 (1) 1 (<1) EASIER TO USE CALCIPOTRIENE 0.005% FOAM 167 (25) 108 (16) 80 (12) 39 (6) 7 (1) VEHICLE FOAM 70 (11) 59 (9) 51 (8) 19 (3) 5 (1) CONTINUE ADLs IMMEDIATELY AFTER APPLYING CALCIPOTRIENE 0.005% FOAM 178 (27) 87 (13) 114 (17) 15 (2) 1 (<1) VEHICLE FOAM 82 (12) 50 (8) 62 (9) 8 (1) 1 (<1) LEAVES SKIN FEELING SOFT CALCIPOTRIENE 0.005% FOAM 116 (18) 97 (15) 150 (23) 24 (4) 8 (1) VEHICLE FOAM 39 (6) 44 (7) 81 (12) 33 (5) 6 (1) Patient Perception of Vehicle and How This Influences Adherence to Topical Treatment Regimens�Steven R. Feldman MD, FAAD; Rhonda Schreiber BSN, MS; Kaytiana Crane BS; Madelyn Comito