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 ] u sed for proportions. Safety was assessed. Results: The pooled population consisted of placebo (n=115) or dupilumab 300mg (n=118) treated p atients; demographic and clinical characteristics were balanced between treatment groups. At 12 weeks, dupilumab resulted in EASI change (mean±SD) of 21.1±12.0 from baseline v alues (29.3±12.4), compared with placebo ( 6.9±14.0 from baseline of 31.9±13.7; P<0.0001); percent change was greater with dupilumab, -73.9 percent versus -22.9 percent (P<0.0001). Significantly higher proportions of dupilumab-treated patients achieved EASI-50 compared with placebo (85.6% vs. 32.2%; P<0.0001), EASI-75 (61.0% vs. 13.9%; P<0.0001), and IGA ≤1 (36.4% vs. 3.5%; P<0.0001). Change in SCORAD from baseline was -37.0±18.8 and 10.9±19.6 for dupilumab (baseline 65.8±13.0) and placebo (baseline 68.1±13.5), respectively (P<0.0001); percent change was -56.6 percent dupilumab versus -15.7 percent placebo (P<0.0001). The pooled incidence of adverse events (AEs) through 12 weeks was 80.9 percent with placebo and 81.4 percent with dupilumab, and the three most common AEs (MedDRA Preferred Term) in the dupilumab group were nasopharyngitis, (32.2% dupilumab; 22.6% placebo), headache (14.4% dupilumab; 7.8% placebo), and conjunctivitis (9.3% dupilumab; 1.7% placebo). Limitations: To enable pooling of data from two studies with different double-blind treatment durations, data from Study 1021 was truncated at 12 weeks. Safety is reported through Week 12 in both studies and does not include post-treatment AEs. These studies did not include patients with mild AD. Conclusion: In adults with moderate-to-severe AD, dupilumab significantly improved clinical outcomes relative to placebo; the safety profile in these studies was acceptable and consistent with previous studies. Data first presented at the 23rd World Congress of Dermatology; June 8–13, 2015; Vancouver, Canada. E fficacy of CeraVe Itch Relief Lotion and Cream on Itch Relief in Patients with Atopic Dermatitis Presenters: 1 Matthew J. Zirwas, MD, FAAD; 2 Laurence Dryer, PhD; 2 S ylvia Barkovic, BA Affiliations: 1 Ohio Contact Dermatitis Center, Columbus, OH; 2 Valeant Pharmaceuticals North America LLC, Irvine, CA. O bjectives: To evaluate the speed of onset and duration of relief of two ceramide-containing formulations with 1% pramoxine hydroxide (CeraVe Itch Relief Lotion and Cream) in patients with atopic dermatitis (AD), including those with active flare. Methods: Double-blind, split-body, randomized, monadic study in 34 male and female subjects, ages 11+ years, with history of AD. Itch severity was assessed on a 10-point scale (where 0=none and 7–9=severe). Single applications of ceramide-containing lotion or cream incorporating 1% pramoxine hydrochloride applied to opposite sides of the body, following a 3- or 7-day washout period (for moisturizers/OTC products or prescription AD medications, respectively). Itch relief assessed at baseline, 2 and 5 minutes, 1, 4, and 8 hours post-application. Efficacy and aesthetic attributes were assessed at the same timepoints. Results: Relief of itching was rapid and long-lasting with significant reductions in severity after two minutes, and continued improvement over the eight-hour test period (P<0.001 versus baseline at all timepoints). Mean itch severity scores reduced progressively from 6 (moderate) at baseline to 1–2 (mild) after eight hours, with all patients experiencing relief from itching. Rapid and long-lasting relief to dry, itchy, irritated skin; and relief from associated pain and discomfort were confirmed through patient self- assessment. Both formulations were non-greasy, absorbed quickly and easily, and were non-irritating. Limitations: Results are based on a single application. Conclusion: Ceramide-containing lotion or cream containing 1% pramoxine provides both rapid and l ong-lasting relief of itching following a single application in patients with AD with or without active flare. Both formulations were well-tolerated with aesthetic appeal. Results From Two Phase 3 Studies in Children and Adults With Mild- to-Moderate Atopic Dermatitis Treated With Crisaborole Topical O intment, 2%, a Novel Nonsteroidal, Topical Anti- Inflammatory, Phosphodiesterase 4 Inhibitor Presenters: 1 AS Paller; 2,3 WL Tom; 4 MG Lebwohl; 5 RL Blumenthal; 6,7 M Boguniewicz; 8 RS Call; 2,3 LF Eichenfield; 9 DW Forsha; 10 WC Rees; 1 1 EL Simpson; 1 2 LF Stein Gold; 1 3 AL Zaenglein; 5 LT Zane; 14 AA Hebert Affiliations: 1 Northwestern University, Feinberg School of Medicine, Chicago, IL; 2 Rady Children's Hospital, San Diego, CA; 3 University of California, San Diego, La Jolla, CA; 4 Icahn School of Medicine at Mount Sinai, New York, NY; 5 Anacor Pharmaceuticals, Inc., Palo Alto, CA; 6 National Jewish Health, Denver, CO; 7 University of Colorado School of Medicine, Denver, CO; 8 Clinical Research Partners, Richmond, VA; 9 Jordan Valley Dermatology & Research Center, West Jordan, UT; 10 PI-Coor Clinical Research, Burke, VA; 11 Oregon Health and Science University, Portland, OR; 12 Henry Ford Health System, Detroit, MI; 13 Pennsylvania State University, Hershey, PA; 14 University of Texas Health Science Center Houston, Houston, TX Objectives: Atopic dermatitis (AD) is an inflammatory skin disease affecting children and adults, and up to 90 percent of patients present with mild-to-moderate AD. Crisaborole Topical Ointment, 2% (Anacor Pharmaceuticals, Palo Alto, CA) is an investigational, nonsteroidal, topical, anti-inflammatory, phosphodiesterase 4 inhibitor. Two Phase 3 studies (NCT02118766, NCT02118792) were conducted to evaluate Crisaborole Topical Ointment, 2% in mild-to- moderate AD. Methods: Patients ≥2 years old with mild-to-moderate AD affecting ≥5% of S 1 0

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