Journal of Clinical and Aesthetic Dermatology

MauiDerm 2017

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

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S29 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) a fter one year and 1.7 after two years o ff-drug versus 20.5 and 19.2 at baseline. Mean duration of disease at baseline was 14 to 16 years, indicating secukinumab treatment was a late intervention. The longer the duration of psoriasis, the less likely the relapse-free outcome was. However, after s ecukinumab treatment, histological and most gene expression abnormalities were reversed. Conclusion: This is the first robust long-term data on psoriasis following treatment discontinuation. Long after secukinumab discontinuation, a high proportion of patients did not revert to their baseline severity and even stayed relapse-free. Secukinumab appears to be able to modify the course of moderate-to-severe psoriasis, even when intervening late in its course. DFD-01, a Midpotent Betamethasone Dipropionate 0.05% in an Emollient-like Spray Formulation, Demonstrates Similar Efficacy to a Super Potent Topical Steroid for the Treatment of Moderate Psoriasis Presenters: Linda Stein Gold, MD, 1 David Pariser, MD, 2 J. Mark Jackson, MD 3 Affiliations: 1 Henry Ford Medical Center, Detroit, MI; 2 Virginia Clinical Research, Inc., Norfolk, VA; 3 University of Louisville, Louisville, KY Introduction: Topical steroids for the treatment of mild-to-moderate plaque psoriasis are classified according to potency, with super potent steroids typically demonstrating the highest efficacy. Understanding of steroid action in the skin has driven development of vehicle characteristics that improve steroid penetration to and persistence within the dermis and epidermis while minimizing permeation into the circulation. T his study compares DFD-01, a m idpotent, emollient-like spray formulation of 0.05% betamethasone dipropionate, with a super potent augmented betamethasone dipropionate 0.05% lotion (AugBD) for the treatment of moderate plaque psoriasis. M ethods: Data from two Phase 3 randomized trials that enrolled 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). Treatments were applied twice daily to all affected areas, excluding face, scalp, and intertriginous areas for 14 or 29 days. AugBD was applied for 14 days per label. Treatment success was defined as Investigator Global Assessment (IGA) score of 0 or 1 and ≥2 point improvement from baseline. Other measures included total sign score (TSS) for a target lesion, individual sign scores, percentage of subjects with ≥50- percent reduction in TSS (TSS50) and TSS ≤1 for any sign. Results: Overall, 356 subjects received DFD-01, 90 AugBD, and 182 vehicle. Pooled results for IGA were similar for DFD 01 and AugBD through the comparative treatment period, and DFD-01 had significantly greater treatment success than vehicle at Days 8, 15, and 29 (p≤0.010). TSS showed consistent improvement with both DFD-01 and AugBD. The percentage of subjects achieving TSS ≤1 for all signs was significantly higher for DFD-01 than AugBD at Day 4 and Day 15 (p≤0.033), and significantly higher for DFD-01 than vehicle at all time points (p≤0.009). Pooled TSS50 results showed similar results. Erythema, scaling, and plaque elevation ratings improved with both D FD-01 and AugBD. Individual sign s cores of 0 (clear) were achieved in significantly more DFD-01 subjects than vehicle at Day 15 and Day 29 (p≤0.007). Conclusion: In this study, DFD-01 showed similar clinical efficacy to an augmented betamethasone d ipropionate 0.05% lotion on global measures of IGA, TSS, and TSS50 in the treatment of moderate plaque psoriasis. DFD-01, classified as midpotent on vasoconstrictor assay (VCA), demonstrated efficacy similar to a VCA-classified super potent augmented betamethasone dipropionate 0.05% lotion. Financial diclosures/funding: This study was funded and sponsored by Promius Pharma, Princeton, NJ. Disclosures: Dr. Stein Gold is a paid consultant for Promius Pharma and Leo Pharma. Dr. Gold has received research funding and speaker fees from Leo Pharma. Dr. Pariser has received honoraria from Bickel Biotechnology, Biofrontera AG, Celgene Corp., Dermira, DUSA Pharmaceuticals, Inc., Leo Pharma, US Novartis Pharmaceuticals Corp., Pfizer Inc., Regeneron, and Valeant Pharmaceuticals International. He has received grants and/or research funding from Abbott Laboratories, Amgen, Bickel Biotechnology, Celgene Corp., Eli Lilly, Leo Pharma, US, Novartis Pharmaceuticals Corp., Novo Nordisk A/S, Ortho Dermatologics, Pfizer Inc., Photocure ASA, Regeneron, Stiefel GSK Co., and Valeant Pharmaceuticals International. Dr. Jackson has received research, honoraria, consulting, and/or other support from Promius Pharma, AbbVie, Amgen, Celgene, Dermira, Galderma, Genentech, Janssen, Lilly, Medimetriks, Merck, Novartis, Pfizer, and Top MD.

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