Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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[ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y S13 d ecreases in mPASI with Cal/BD aerosol foam were noted versus all other treatments at Week 1 (Cal/BD aerosol foam, 39%; Cal/BD ointment, 31%; BD aerosol foam, 32%; Cal a erosol foam, 27%; aerosol foam vehicle, 22%; ointment vehicle, 27%) as well as Week 4 (71%, 63%, 53%, 43%, 32% and 33%, respectively). Week 4 PASI75 rates were also greater ( 51%, 41%, 34%, 18%, 7% and 10%, respectively). Cal/BD aerosol foam was efficacious irrespective of baseline disease severity (treatment success: 30% mild; 59% moderate; 33% severe baseline disease) and on all body areas assessed (i.e., arms, legs, and trunk). Cal/BD aerosol foam treatment resulted in substantial alleviation of itch at Week 1 (change in itch VAS: - 30); itch relief further increased at Week 4 (change in itch VAS: -41). Limitations: As each clinical study evaluated Cal/BD aerosol foam versus different comparators, pooling resulted in unequal patient numbers across treatment groups; this must be considered during data interpretation. Conclusion: Cal/BD aerosol foam was significantly more effective than Cal/BD ointment and each of its individual active ingredients for the treatment of psoriasis vulgaris, resulting in a greater reduction in disease severity and a rapid, effective relief of itch. Efficacy of Secukinumab in Patients with Plaque Psoriasis: Area Under the Curve of Treatment Response Rates Presenters: 1 April W. Armstrong; 2 Steven R. Feldman; 3 Neil J. Korman; 4 Xiangyi Meng; 4 Adriana Guana; 4 Judit Nyirady; 4 Vivian Herrera; 4 Yang Zhao Affiliations: 1 University of Colorado Denver School of Medicine, Aurora, CO; 2 Wake Forest University School of Medicine, Winston-Salem, NC; 3 University Hospitals Case Medical Center, Cleveland, OH; 4 Novartis Pharmaceuticals Corporation, East Hanover, NJ Background: Assessment of how therapies achieve cumulative disease control over time is critical. In two Phase 3, 52-week trials (ERASURE and FIXTURE), secukinumab—a h uman, anti–interleukin-17A, monoclonal antibody—was an effective treatment for moderate-severe chronic plaque psoriasis. Pooled analysis of these trials was performed to explore t he cumulative efficacy of secukinumab by assessing area-under- the-curve (AUC) of percentage of treatment responders according to Psoriasis Area and Severity Index ( PASI) and Dermatology Life Quality Index (DLQI) scores. Methods: All patients who stayed on the same active treatment for 52 weeks were included. Active treatments were subcutaneous secukinumab 300mg (n=568) or 150mg (n=570) at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks, and subcutaneous etanercept 50mg twice weekly for 12 weeks and then once weekly (n=323). Total AUCs over the 52-week period by percentage of PASI-75/90/100 and DLQI-0/1 (no impact on patient quality of life) responders—measuring overall controlled disease time—were determined using all responder numbers at all scheduled visits. Results: Total AUCs for patients who received secukinumab 300 and 150mg, and etanercept, respectively, were: 3857.8, 3286.9, and 2628.1 (PASI-75); 3017.7, 2212.2, and 1531.8 (PASI-90); 1677.0, 978.9, and 452.5 (PASI-100); and 3029.8, 2492.2, and 1991.4 (DLQI-0/1). Total AUC ratios for secukinumab 300 and 150mg, respectively, versus etanercept were 1.47 and 1.25 (PASI-75); 1.97 and 1.44 (PASI-90); 3.71 and 2.16 (PASI-100); and 1.52 and 1.25 (DLQI-0/1). Total AUC ratios for secukinumab 300 versus 150mg were 1.17 (PASI-75), 1.36 (PASI-90), 1.71 (PASI-100), and 1.22 (DLQI-0/1). Conclusion: In patients with moderate-severe plaque psoriasis, greater AUCs by PASI-75/90/100 and DLQI-0/1 responders were achieved with secukinumab 300mg, followed by secukinumab 150mg and etanercept. This analysis suggests that secukinumab 300mg resulted in the best overall disease control over time. DFD-01, a Class 3/4 Betamethasone Dipropionate 0 .05% Emollient Formulation Demonstrates Similar Efficacy to a Class 1 Topical Steroid for the Treatment of Moderate Psoriasis Presenters: 1 Linda Stein Gold; 2 D avid Pariser; 3 J . Mark Jackson Affiliations: 1 Henry Ford Medical Center, Detroit, MI; 2 Virginia Clinical Research, Inc., Norfolk, VA; 3 University of Louisville, Louisville, KY I ntroduction: Topical steroids are routinely used for the treatment of mild-to-moderate psoriasis. Steroids are classified according to potency with Class 1 (or super potent) steroids having historically demonstrated the highest efficacy. Research into the site of steroid action within the skin has driven development of novel vehicles to ensure the steroid reaches and remains within the dermis and epidermis and minimizes permeation into the systemic system. DFD-01, a Class 3/4 emollient spray formulation of 0.05% betamethasone dipropionate is compared here with a Class 1 augmented betamethasone dipropionate 0.05% steroid lotion (Diprolene [AugBD]) for the treatment of moderate plaque psoriasis. Methods: Data from two Phase 3, randomized, clinical trials enrolling adults with moderate plaque psoriasis (Investigator Global Assessment [IGA]=3; 10 to 20% BSA) were pooled. Subjects were randomized to receive DFD-01, AugBD, or Vehicle Spray (DFD-01 Vehicle). Products were applied twice daily to all affected areas on the body excluding face, scalp, and intertriginous areas for 14 or 29 days. AugBD was only applied for 14 days, as per labelling. Treatment success was defined as an IGA=0 or 1 and ≥2- grade improvement from baseline. Other measures of efficacy included the reduction in total sign score (TSS) for a target lesion (TSS=the sum of erythema, plaque and elevation scores), individual sign scores, the percentage of subjects who achieved ≥50% reduction in TSS (TSS50) and TSS≤1 for any sign. Analysis was by Fisher's exact test. Results: Overall, 356 subjects received DFD-01, 90 AugBD, and 182 vehicle. Pooled IGA results showed that DFD-01 and AugBD demonstrated S 1 3

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