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 S24 journal of clinical and aesthetic dermatology JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) D avid Geffen School of Medicine at U niversity of California, Los Angeles, CA; 5 Valeant Pharmaceuticals North America LLC, Bridgewater, NJ; 6 Dow Pharmaceutical Sciences (a division of Valeant Pharmaceuticals North America, LLC), Petaluma, CA Background: Psoriasis is a chronic, i mmune-mediated disease characterized by thick, scaly plaques. It has a debilitating effect on quality of life with higher risk for anxiety and depression. The interkeukin-17 (IL-17) pathway plays an important role in the disease pathogenesis. Brodalumab, a fully human interleukin-17 receptor A (IL-17RA) monoclonal antibody, has demonstrated efficacy in Phase 2 and Phase 3 trials in patients with moderate-to-severe plaque psoriasis. Objective: To investigate the maintenance of efficacy of brodalumab in subjects with moderate or severe plaque psoriasis. Methods: Three multicenter, randomized, double-blind studies in moderate-to-severe psoriasis (N=4,632, safety population); two were ustekinumab-controlled. AMAGINE-1: Following a 12-week brodalumab or placebo induction phase subjects were re-randomized to brodalumab (210mg Q2W, 140mg Q2W) or placebo. AMAGINE-2 and -3: Following a 12- week brodalumab, ustekinumab or placebo induction phase subjects were re-randomized to brodalumab (210mg Q2W, 140mg Q2W, 140mg Q4W, 140mg Q8W) or remained on ustekinumab for a further 40 weeks. Maintenance of efficacy was assessed by the proportion of subjects who achieved static Physician's Global Assessment (sPGA) success (0 or 1), and those with Psoriasis Area and Severity Index (PASI) response (PASI 100) at Week 52. Results: AMAGINE-1: 75.7 and 53.9 percent of subjects achieved sPGA s uccess (clear or almost clear) at Week 1 2 with brodalumab 210mg Q2W and 140mg Q2W, respectively. 83.1 and 70.2 percent of subjects re-randomized to continue with brodalumab 210mg Q2W or 140mg Q2W, respectively, achieved sPGA success at Week 52, compared with zero and five percent of subjects, r espectively, who were re-randomized to placebo (both P<0.001). AMAGINE-2 and AMAGINE-3: At week 12, 79.9 percent of subjects treated with brodalumab 210mg Q2W achieved sPGA success compared with 61.2 percent on ustekinumab, and 41.6 percent achieved PASI 100 compared with 20.7 percent on ustekinumab. At week 52, 64.9 percent of subjects on constant dose brodalumab 210mg Q2W achieved sPGA success compared with 45.3 percent on ustekinumab, and 51 percent achieved PASI 100 compared with 28.1 percent on ustekinumab (both P<0.001). Conclusion: The significant improvements in clinical outcomes seen with brodalumab treatment were maintained through Week 52 with continued treatment. Results with brodalumab 210mg Q2W were significantly superior compared to ustekinumab. Safety and Efficacy of Apremilast through 104 Weeks in Patients with Moderate to Severe Psoriasis who Continued on Apremilast or Switched from Etanercept Treatment in the LIBERATE Study Presenters: Kristian Reich, 1 Mark Goodfield, 2 Lawrence Green, 3 Kristine Nograles, 4 Rongdean Chen, 4 Eugenia Levi, 4 Richard G. B. Langley 5 Affiliations: 1 Dermatologikum Hamburg, Hamburg, Germany; 2 Leeds General Infirmary, Leeds, UK; 3 George Washington University School of Medicine, Washington, DC; 4 Celgene C orporation, Summit, NJ; 5 D alhousie U niversity, Halifax, NS, Canada Introduction: LIBERATE is a Phase 3b study evaluating apremilast 30mg twice daily (APR) and etanercept 50mg once weekly (ETN) efficacy and safety vs. placebo in biologic-naive patients with moderate-to-severe plaque p soriasis. We report efficacy and safety through 104 weeks. Study Methods: Patients were randomized to placebo, APR, or ETN through Week 16; thereafter, all patients continued or switched to APR through Week 104. Achievement of ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI-75; primary end point, Week 16), minimal clinically important difference (MCID) in Dermatology Life Quality Index (DLQI) score (improvement ≥5 points), Scalp Physician Global Assessment (ScPGA) score of 0 or 1 in patients with a baseline score ≥3, and ≥50- percent improvement in Nail Psoriasis Severity Index (NAPSI-50) in patients with a baseline score ≥1 in the target nail were assessed. Efficacy assessments were conducted in the modified intent-to-treat population (Week 16) and in patients who entered and were treated in the APR extension phase (Weeks 16 to ≤104); last- observation-carried-forward methodology was used. Results: The APR extension phase (Weeks 16 to ≤104) included 226 patients (placebo/APR n=73; APR/APR n=74; ETN/APR n=79). At Week 104, PASI 75 response was 45.9 percent among patients who continued APR (APR/APR), and 51.9 and 50.7 percent among patients who switched from ETN (ETN/APR) and placebo ( placebo/APR) to APR at Week 16, respectively; among patients with a DLQI score >5 at baseline, DLQI MCID was achieved by 62.7 percent of placebo/APR, 71.2

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