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 S26 journal of clinical and aesthetic dermatology JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) E fficacy and Safety of Apremilast i n Patients with Moderate Plaque Psoriasis with Lower BSA (UNVEIL Phase 4 Study) Presenters: Bruce Strober, 1 Jerry Bagel, 2 Mark Lebwohl, 3 Linda Stein Gold, 4 J. Mark Jackson, 5 Rongdean Chen, 6 Joana Goncalves, 6 Eugenia L evi, 6 K ristina Callis Duffin 7 Affiliations: 1 University of Connecticut, Farmington, CT, and Probity Medical Research, Waterloo, ON, Canada; 2 Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ; 3 Icahn School of Medicine at Mount Sinai, New York, NY; 4 Henry Ford Health System, West Bloomfield, MI; 5 University of Louisville, Forefront Dermatology, Louisville, KY; 6 Celgene Corporation, Summit, NJ; 7 University of Utah, Salt Lake City, UT Introduction: Patients with moderate plaque psoriasis are often inadequately treated, and there remains an unmet medical need for an effective and convenient treatment option in this population. UNVEIL is the first randomized, placebo (PBO)-controlled trial to prospectively evaluate the clinical efficacy and safety of a systemic treatment, oral apremilast, in patients with moderate plaque psoriasis with body surface area (BSA) involvement of 5 to 10 percent who are naive to systemic and biologic therapy. Study Methods: Patients with chronic plaque psoriasis having a BSA of 5 to 10 percent and a static Physician's Global Assessment (sPGA) of 3 (moderate, 0–5 scale), with no prior exposure to systemic treatments or biologics, were randomized (2:1) to apremilast 30mg twice daily (APR) or PBO for 16 weeks. The primary efficacy endpoint was the mean percentage change from baseline in the product of sPGA and BSA (PGAxBSA) at Week 16. Scalp psoriasis was a ssessed with the Scalp Physician's G lobal Assessment (ScPGA). Results: 221 patients were randomized (PBO n=73; APR n=148). At baseline, mean BSA was seven percent, PGAxBSA was 21.7, Psoriasis Area and Severity Index (PASI) was 8.1, and >80 percent of patients were on t opical therapy before enrollment. Patients who received APR had a mean improvement in PGAxBSA of 48.1 versus 10.2 percent in the PBO group at Week 16 (P<0.0001). In addition, 35 percent of APR patients achieved ≥75- percent improvement from baseline in PGAxBSA (PGAxBSA-75) relative to 12.3 percent of PBO patients (P=0.0136). Significantly more APR patients achieved an sPGA score of 0 (clear) or 1 (almost clear) at Week 16 compared with PBO (30.4% vs. 9.6%; P<0.0001). More than 75 percent (n=167) of enrolled patients presented with psoriasis of the scalp, and significantly more patients treated with APR achieved a score of 0 (clear) or 1 (minimal) with a ≥2-point improvement on ScPGA relative to PBO (38.0% vs. 20.0%; P=0.0178). The majority of adverse events (AEs) were mild to moderate in severity. The most common AEs (occurring in ≥5% of patients in either treatment group) were diarrhea, headache, nausea, upper respiratory tract infection, decreased appetite, and vomiting. Conclusion: APR is effective in the treatment of systemic-naive, post- topical patients with moderate plaque psoriasis. Safety and tolerability were consistent with other published studies. Rapid Onset of Efficacy in Patients with Psoriasis Treated with Ixekizumab: A Pooled Analysis of Data from Two Phase 3 Randomized Clinical Trials (UNCOVER-2 and UNCOVER-3) P resenters: Craig Leonardi, 1 R ichard L angley, 2 A ndrew Blauvelt, 3 K enneth Gordon, 4 David Stanley Shrom, 5 Lisa Nichole Farmer Kerr, 5 Ivaylo Stoykov, 5 Clement Ojeh, 5 Kristian Reich 6 Affiliations: 1 Saint Louis University School of Medicine, St Louis, MO; 2 Dalhousie University, Halifax, NS, C anada; 3 O regon Medical Research Center, Portland, OR; 4 Northwestern University Feinberg School of Medicine, Chicago, IL; 5 Eli Lilly and Company, Indianapolis, IN; 6 Ddermatologikum Hamburg, Hamburg, Germany Introduction: For patients with psoriasis, rapid onset of clinical improvement is one of the most important attributes of treatment success. In addition, it has been demonstrated that clinical improvement observed early during treatment has predictive value for subsequent clinical response at later time points. In this analysis, we evaluated the speed of onset of clinical improvement in psoriasis patients treated with ixekizumab (IXE; a high- affinity monoclonal antibody that selectively targets interleukin-17A [IL- 17A]) compared with placebo and the active comparator, etanercept (ETN). Methods: Combining data from the 12-week induction phase of UNCOVER- 2 and UNCOVER-3, 2,570 patients with moderate-to-severe plaque psoriasis were randomized to receive placebo (PBO, n=361), high-dose ETN (50mg bi- weekly; n=740), or a single 80mg subcutaneous injection of IXE once every two weeks (IXE Q2W; n=736) or every four weeks (IXE Q4W; n=733) after receiving a 160mg initial dose at Week 0. Mean percentage improvement was analyzed by MMRM and response rates by Cochran-Mantel-Haenszel test, where missing data were imputed using nonresponse. Time to PASI 75 was

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