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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JCAD Toll-free: (866) 325-9907 • Phone: (484) 266-0702 • Fax: (484) 266-0726 S16 journal of clinical and aesthetic dermatology JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) R , 5 S herif B, 6 W illiams N, 6 F ox T, 3 A ugustin M 7 Affiliations: 1 Oregon Medical Research Center, Portland, OR; 2 University Hospitals of Cleveland, Cleveland, OH; 3 Novartis Pharma AG, Basel, Switzerland; 4 Novartis Pharmaceuticals Corporation, East H anover, NJ; 5 N ovartis Pharma AG, Shanghai, China; 6 RTI Health Solutions, Research Triangle Park, NC; 7 Institute for Health Services Research in Dermatology and Nursing University Medical Center Hamburg Introduction and Objectives: Secukinumab, a fully human monoclonal antibody (mAb) that selectively targets IL-17A, is highly efficacious in the treatment of moderate-to-severe plaque psoriasis, starting at early time points, with a sustained effect and a favorable safety profile. CLEAR is a Phase 3b study comparing the efficacy and safety of secukinumab versus ustekinumab, an anti-IL-12/23 mAb, in adults with moderate-to-severe plaque psoriasis. This analysis focused on the treatment effect on skin-related quality of life as measured by the Dermatology Life Quality Index (DLQI) as well as its association with skin clearance as measured by the Psoriasis Area and Severity Index (PASI). Materials and Methods: Data from baseline to Week 16 for patients aged ≥18 years randomized 1:1 to subcutaneous treatment groups (secukinumab 300mg and ustekinumab 45mg or 90mg according to body weight at baseline) were used for this analysis. The DLQI was administered at baseline and Weeks 4, 8, 12, and 16, with total and subscale scores computed at all visits. DLQI response was defined as no effect of skin problems on health-related quality-of- life (DLQI total score of 0 or 1).Time to r esponse was computed as the period f rom the randomization date to the time when DLQI 0/1 response had occurred. Median time to response was compared between treatment groups using Kaplan-Meier methods with a log- rank test. Results: Mean (SD) baseline DLQI t otal scores were similar for both treatment arms: secukinumab 13.4 (7.63); ustekinumab 13.2 (7.57). The mean DLQI total score as well as all subscale scores (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment scores) improved (decreased) continuously over the treatment period in both treatment groups, with more pronounced improvements in the secukinumab arm than the ustekinumab arm at all visits (Weeks 4, 8, 12, 16) (p<0.001 on DLQI total score). Up to Week 16, 80.7 percent of subjects treated with secukinumab achieved DLQI response (0/1) versus 69.3 percent treated with ustekinumab (p<0.0001). The median time to DLQI response (0/1) was significantly shorter for secukinumab compared to ustekinumab (8 weeks vs. 12 weeks, p<0.0001). Conclusion: Secukinumab treatment provides stronger and faster relief from patient-reported quality-of- life than ustekinumab in patients with moderate-to-severe plaque psoriasis. DFD-01, an Emollient-Like Spray Formulation of 0.05% Betamethasone Dipropionate, Effectively Treats Plaque Psoriasis on Knees and Elbows Presenters: Leon Kircik, MD, 1 Jerry Bagel, MD 2 Affiliations: 1 DermResearch, PLLC, Louisville, KY; 2 Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ I ntroduction: DFD-01 is an e mollient-like spray formulation of 0.05% betamethasone dipropionate approved for the treatment of mild-to- moderate plaque psoriasis in adults. The DFD-01 formulation was designed to penetrate the outer stratum corneum and be retained within the dermis and e pidermis, the site of psoriasis pathologic activity. Plaque psoriasis affecting knees and elbows can be difficult to treat, and these lesions are sometimes excluded from psoriasis clinical trials. This post hoc analysis compares the efficacy of a midpotent betamethasone (DFD-01) and a super potent augmented betamethasone (AugBD) on knee and elbow plaques in subjects with moderate plaque psoriasis Methods: Two Phase 3 clinical trials randomized adults with moderate plaque psoriasis (Investigator Global Assessment [IGA] =3; 10 to 20% BSA) to DFD 01, AugBD, or vehicle. Treatments were applied twice daily to all affected areas for 14 or 28 days. AugBD was applied for 14 days per label. In this post hoc analysis, subjects with target plaques on the knees or elbows were selected from the total population. Success was defined as (1) a score of 0 or 1 (reducing the plaque to 'clear' or 'slight to mild') for erythema, scaling, and plaque elevation; and (2) total sign score (TSS) ≤1 for all three signs (erythema, scaling, and plaque elevation) for a target lesion. 37.9 percent of 628 subjects had a target lesion located on their elbow or knee selected for assessment (DFD 01, n=133; AugBD, n=32; Vehicle, n=71). Treatment success through Day 15 was analyzed using Fisher's exact test. Results: DFD-01 and AugBD showed similar efficacy on knee and elbow lesions beginning at Day 4 on ratings of erythema, scaling, plaque elevation, and © 2016 Matrix Medical Communications • 1595 Paoli Pike • Suite 201 • West Chester, PA 19380

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