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 ] 2 Y ves Poulin, MD; 3 C hristopher E. M. Griffiths, MD; 4 Sergio Chimenti, MD; 5 Howard Sofen, MD; 6 Sandra Philipp, MD; 7 ChiaChi Hu, EdM, MS; Robert M. Day, PhD; 8 Giampiero Girolomoni, MD A ffiliations: 1 U niversity Hospitals Case Medical Center, Cleveland, OH; 2 Centre de Recherche Dermatologique du Québec métropolitain, Québec, QC, Canada; 3 The Dermatology Centre, The U niversity of Manchester, Manchester, UK; 4 University of Rome Tor Vergata, Rome, Italy; 5 Department of Medicine/Dermatology, UCLA School of Medicine, Los Angeles, CA; 6 Charité Campus Mitte, Universitaetsmedizin Berlin, Berlin, Germany; 7 Celgene Corporation, Warren, NJ; 8 University of Verona, Verona, Italy Background: ESTEEM 1 and 2 evaluated the efficacy and safety of apremilast (APR) in patients with moderate-to-severe plaque psoriasis. This analysis evaluated APR efficacy in specified subpopulations. Methods: In ESTEEM 1 and 2, patients with moderate-to-severe plaque psoriasis (PASI ≥12, BSA ≥10%, sPGA ≥3) were randomized (2:1) to APR 30mg BID (APR30) or placebo (PBO). At Week 16, all PBO patients switched to APR30 through Week 32. This was followed by a randomized treatment withdrawal phase up to Week 52. Subgroup analyses were based on baseline demographics (e.g., gender, race, age, body weight, body mass index), baseline disease characteristics (e.g., disease duration, history of nail, scalp, and palmoplantar psoriasis), and prior psoriasis therapies. Using data pooled from ESTEEM 1 and 2, efficacy was evaluated at Week 16 by baseline PASI score (≤20, >20) and number/type of prior and failed psoriasis therapies (including phototherapy, conventional systemics, biologics, or TNF blockers). Results: The pooled analyses included 1,255 patients who entered the PBO-controlled phase (PBO: n=419; APR30: n=836). At Week 16, PASI-75 responses (primary end point) were significantly greater with APR30 (ESTEEM 1: 33.1%; ESTEEM 2: 28.8%) versus PBO (ESTEEM 1: 5.3%; ESTEEM 2: 5.8%; P<0.0001). The primary end point analysis c onsistently demonstrated the treatment benefit of APR30, relative to PBO, across multiple demographic and disease characteristic subgroups, including baseline disease severity ( moderate vs. severe psoriasis) and whether or not patients had been treated previously with systemic (including biologics) psoriasis treatments. Although not significant, t here were trends for higher PASI-75 responses in patients with PASI scores ≤20 at baseline and patients who had not received prior systemic therapies. Subpopulation analyses of sPGA 0 (clear) or 1 (almost clear) achievement and PASI-50 responses had similar findings Conclusion: In pooled analyses of PASI-75, PASI-50, and sPGA responses at Week 16 in ESTEEM 1 and 2, APR30 was effective across subgroups regardless of baseline demographics or prior psoriasis therapy. Safety of Apremilast and Etanercept Compared With Placebo in Patients With Moderate to Severe Psoriasis: Results From the LIBERATE Study Presenters: 1 Melinda Gooderham, MD; 2 Jennifer Soung, MD; 3 Lawrence Green, MD; 4 Matthias Augustin, MD, PhD; 5 Zuoshun Zhang, PhD; 5 Kamal Shah, MD; 5 Joana Goncalves, MD; 6 Kristian Reich, MD Affiliations: 1 Skin Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada; 2 University of California, Irvine, CA; 3 George Washington University School of Medicine, Washington, DC; 4 Institute for Health Services, Research in Dermatology and Nursing – IVDP, University Medical Center of Hamburg Eppendorf Augustin, Hamburg, Germany; 5 Celgene Corporation, Warren, NJ, USA; 6 SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany Background: The Phase 3b LIBERATE (Evaluation in a Placebo- Controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis) double-blind, double-dummy study evaluated efficacy and safety of apremilast (APR) or etanercept (ETN) v ersus placebo (PBO) in biologic-naive patients with moderate-to-severe plaque psoriasis. Methods: In this study patients were randomized (1:1:1) to PBO, APR 30mg B ID (APR30), or ETN 50mg QW (ETN50) through Week 16; thereafter, patients receiving PBO (PBO/APR30) or ETN50 (ETN50/APR30) switched to APR30 through Week 104. Patients in t he APR30 group continued treatment (APR30/APR30) through Week 104. Adverse events (AEs) were assessed for Weeks 0 to 16 and Weeks 16 to 32. Results: 250 randomized patients received ≥1 dose of study drug and were included in the safety analysis (PBO n=84; APR30 n=83; ETN50 n=83). The most common AEs (≥5% of patients) were headache, nausea, diarrhea, upper respiratory tract infection (URTI), tension headache, and nasopharyngitis. Across all subgroups: severe or serious AEs were reported in ≤3 patients and ≤3 patients discontinued due to AEs. For Weeks 0 to 16, serious infections were pneumonia n=1 APR30, n=1 ETN50; no serious infections were reported for Weeks 16 to 32. No malignancies were reported. History of depression was reported at baseline in 9.5, 16.9, and 7.2 percent of patients, respectively, in the PBO, APR30, and ETN50 arms. Rates of depression and depressed mood with APR30 were low, occurring in patients with a prior history or with depression at baseline (Weeks 0–16, depression n=1 APR30; Weeks 16–32, depression n=1; depressed mood, n=1 APR30/APR30). Suicidal ideation (n=1 PBO/APR30) was reported for Weeks 16–32. At Week 16, mean percent change from baseline in weight was +0.17%, -0.81%, and +1.44% with PBO, APR30, and ETN50, respectively. At Week 32, mean percent change from baseline in weight was -0.52%, - 0.78%, and +0.09% with PBO/APR30, APR30/APR30, and ETN50/APR30, respectively. Conclusion: The safety profile of APR30 was acceptable in patients with moderate-to-severe plaque psoriasis. No new safety or tolerability issues were observed between Week 16 and Week 32 in patients who switched from ETN50 to APR30 at Week 16. S 1 6

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