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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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 [ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] s imilar treatment success throughout the comparative treatment period, while DFD-01 was significantly superior to vehicle at Day 8, 15, and 29 (p≤0.010). Reduction in TSS showed c onsistent improvement with both DFD-01 and AugBD, with DFD-01 showing slightly higher rates of improvement. The percentage of subjects achieving a TSS of ≤1 for all of t he three signs was significantly higher for DFD-01 than Diprolene at Day 4 and Day 15 (p≤0.033) and was significantly higher for DFD-01 than vehicle for all timepoints (p≤0.009). Pooled TSS50 results showed similar trends in efficacy, with 50 percent of DFD-01 subjects achieving TSS50 at Day 15 versus 41 percent of AugBD subjects. Erythema, scaling, and plaque elevation were all improved with both DFD-01 and AugBD with individual sign scores of 0 (clear) achieved in significantly more DFD-01 subjects versus vehicle at Day 15 and Day 29 (p≤0.007). Conclusion: The medium potency, Class 3/4 DFD-01 showed similar clinical efficacy to the super potent, Class 1 AugBD on global measures of IGA, TSS, and TSS50 for the treatment of moderate plaque psoriasis. DFD-01's novel formulation appears to confer the efficacy of a Class 1 steroid despite its vasoconstrictor assay classification of Class 3/4. Financial disclosures/funding: Promius Pharma, Princeton, NJ. Secukinumab in Psoriasis: Relationship Between Clinical- and Patient-Reported Outcomes Using Clinical Trial Data from the ERASURE and FIXTURE Trials Presenters: 1 Alice B Gottlieb; 2 Bruce Strober; 3 Mark Lebwohl; 4 Roland Kaufmann; 5 David Pariser; 6 Redzinaldas Narbutas; 7 Judit Nyirady; 7 Yang Zhao; 8 Lori D McLeod; 8 Dawn Odom; 9 Boni E Elewski Affiliations: 1 Tufts Medical Center, Boston, MA; 2 University of Connecticut Health Center, Farmington, CT; Probity Medical Research, Waterloo, ON, Canada; 3 Icahn School of Medicine at Mount Sinai, New York, NY; 4 Department of Dermatology, Venereology and Allergology, Goethe- U niversity, Frankfurt, Germany; 5 Eastern Virginia Medical School, Norfolk, VA; 6 Vilnius University Hospital Clinic, Vilnius, Lithuania; 7 Novartis Pharmaceuticals Corporation, E ast Hanover, NJ; 8 R TI Health Solutions, Research Triangle Park, NC; 9 University of Alabama at Birmingham, Birmingham, AL. Background: Secukinumab, a fully h uman anti-interleukin 17A monoclonal antibody, was evaluated in ERASURE and FIXTURE, two Phase 3 multicenter double blind versus placebo clinical studies, for efficacy and safety in subjects with moderate- to-severe plaque psoriasis. Data from these trials provided an opportunity to evaluate the relationship between traditional clinical outcomes and patient-reported symptoms. Methods: Patients aged ≥18 years were randomized 1:1:1 in ERASURE to receive subcutaneous treatment with secukinumab 300mg, secukinumab 150mg, or placebo; and 1:1:1:1 in FIXTURE, which included etanercept 50mg twice weekly. The co-primary endpoints were the Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment Mod 2011 Rating Scale (IGA mod 2011). Symptom response was evaluated using the patient-completed Psoriasis Symptom Diary (PSD), which measures psoriasis-related disease characteristics, which subjects have reported as important and relevant to their disease and treatment. Correlation coefficients were calculated at baseline, Week 12, and change from baseline to Week 12 between the PSD weekly itching, pain, and scaling scores and the PASI and IGA mod 2011 scores. Logistic regression evaluated the relationship between itching, pain, and scaling response (improvement of at least 2.2 points for itching and pain and 2.3 points for scaling), and percent change in PASI at Week 12. Results: Approximately 40 percent of patients completed the voluntary PSD. For the pooled analysis (ERASURE n=187, FIXTURE n=266) of secukinumab data, correlation coefficients at baseline were positive but low in magnitude (0.11–0.21) and p ositive and stronger at Week 12 (0.32–0.52). The change from baseline to Week 12 correlation coefficients (0.18–0.30) were positive but lower in magnitude than Week 12 values. Most c oefficients were significant (P<0.001). The logistic models showed that the percent change in PASI score was a significant predictor of PSD response. The likelihood of a response f or psoriasis-related itching, pain, and scaling at Week 12 increased from 77.7, 65.9, and 77.7 percent with a 75% PASI change between baseline and Week 12 to 85.9, 72.6, and 86.1 percent with a 90% PASI change. Conclusion: PASI 90 provides greater symptom response as measured by the PSD than PASI 75. It is important to evaluate both patient- reported outcomes and clinical endpoints to understand the full benefits of a psoriasis treatment. Financial disclosures/funding: Sponsored by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey DFD-01 A Novel Emollient Spray Formulation of 0.05% Betamethasone Dipropionate Effectively Treats Plaque Psoriasis on Knees and Elbows Presenters: 1 Leon Kircik; 2 Jerry Bagel Affiliations: 1 Mount Sinai School of Medicine, New York, NY; 2 Psoriasis Treatment Center of Central NJ, East Windsor, NJ. Introduction: Topical therapies for psoriasis have remained largely unchanged for decades, but remain an important first-line treatment and are often used in combination with other therapies for more severe disease. Topical steroids are effective, but can be associated with the potential to cause systemic side effects. DFD-01 is a novel emollient spray formulation of 0.05% betamethasone dipropionate. This formulation is designed to penetrate the outer stratum corneum and be retained within the dermis and epidermis, the sites of T cell activity that drive the disease process. Plaque psoriasis affecting knees and elbows is notoriously difficult to treat. So much so, that these lesions are often S 1 4

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