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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S23 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) ( P<0.001). Based on induction phase d ata, the median time to achieve PASI 75 or sPGA success with brodalumab was 4.14 and 5.43 weeks, respectively, compared with 8.14 and 10.14 weeks with ustekinumab. The median time to achieve PASI 100 with brodalumab was 12.43 weeks and was inestimable for u stekinumab due to lower rate of response in induction phase. Conclusion: The median time to achieve sPGA (0/1), PASI 75 and PASI 100 response was significantly shorter with brodalumab 210mg Q2W compared to ustekinumab (P<0.001). Median time to achieve a clinically meaningful response (PASI 75 or sPGA success) was twice as long with ustekinumab (8–10 weeks) when compared with brodalumab (4–5 weeks). Further, twice as many patients achieved PASI 100 at Week 12 with brodalumab compared to ustekinumab. Impact of Previous Biologic Use and Failure on Efficacy of Brodalumab and Ustekinumab: A Pooled Analysis of Data from Two Phase 3 Randomized Clinical Trials in Moderate-to-severe Plaque Psoriasis (AMAGINE-2 and AMAGINE-3) Presenters: Kim A. Papp, 1 Mark G. Lebwohl, MD, 2 James G. Krueger, MD, PhD, 3 Alice B. Gottlieb, MD, PhD, 4 Shipra Rastogi, PhD, MBA, 5 Radhakrishnan Pillai, PhD, 6 Robert J. Israel, MD 5 Affiliations: 1 Probity Medical Research, Waterloo, ON, Canada; 2 Icahn School of Medicine at Mount Sinai, New York, NY; 3 Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY; 4 Department of Dermatology, Tufts Medical Center, Boston, MA; 5 Valeant Pharmaceuticals North America LLC, B ridgewater, NJ; 6 D ow Pharmaceutical S ciences (a division of Valeant Pharmaceuticals North America, LLC), Petaluma, CA Background: Psoriasis is a chronic, immune-mediated disease characterized by thick, scaly plaques. The interkeukin-17 (IL-17) pathway p lays an important role in disease pathogenesis. Brodalumab, a fully human interleukin-17 receptor A (IL- 17RA) monoclonal antibody, has demonstrated efficacy in moderate-to- severe plaque psoriasis. Objective: To investigate the impact of previous biologic usage/failure on brodalumab and ustekinumab efficacy in moderate-to-severe plaque psoriasis. Methods: Two multicenter, randomized, double-blind placebo and active-comparator studies in moderate- to-severe psoriasis (N=3712). Initial 12- week induction phase where patients were treated with brodalumab (210mg Q2W or 140mg Q2W), ustekinumab, or placebo. Co-primary endpoint: Psoriasis Area and Severity Index (PASI 100) at Week 12. Enrollment of patients with previous biologic use was capped at 50 percent. Results: Overall, 334 and 159 patients treated with brodalumab 210mg Q2W and ustekinumab, respectively, received prior biologics; with 150 and 62 patients, respectively, reporting previously failed biologic therapy. Proportion of patients treated with brodalumab 210mg Q2W and ustekinumab achieving PASI 100 at Week 12 was 40.9 and 21.1 percent, respectively, in bio-naïve patients, compared with 39.5 and 17 percent in patients with prior biologic use. Where prior biologic use had been successful, proportion of patients treated with brodalumab 210mg Q2W and ustekinumab achieving PASI 100 at Week 12 was 41.7 and 21.1 percent, r espectively, compared with 32 and 1 1.3 percent in patients where previous biologics had failed. Conclusion: Significant improvements in clinical outcomes have been reported following treatment with brodalumab 210mg Q2W in comparison to ustekinumab at Week 12 ( P<0.001). The efficacy of brodalumab 210mg Q2W was similar across patients regardless of their previous biologic therapy use. Overall, twice as many patients achieved PASI 100 at Week 12 with brodalumab 210mg Q2W (range 40–42%) compared with ustekinumab (range 17–21%). In those patients who had failed prior biologics, overall efficacy was lower in both treatment groups. However, there was a three- fold difference in favor of brodalumab 210mg Q2W at Week 12 (32 vs. 11%). While a lower overall efficacy in subjects who had failed prior biologics might be expected, brodalumab demonstrated superior efficacy to ustekinumab in patients who previously failed a biologic treatment in two replicate studies. Maintenance of Clinical Efficacy in Moderate-to-severe Plaque Psoriasis: A 52-week Evaluation of Brodalumab in Three Multicenter, Double-blind Studies of 4363 Subjects Presenters: Kim A. Papp, 1 Mark G. Lebwohl, 2 Lawrence J. Green, 3 Paul S. Yamauchi, 4 Rastogi S, 5 Israel R, 5 Pillai R 6 Affiliations: 1 Probity Medical Research, Waterloo, ON, Canada; 2 Icahn School of Medicine at Mount Sinai, New York, NY; 3 Department of Dermatology, George Washington University School of Medicine, Washington, DC; 4 Dermatology Institute and Skin Care Center, Santa Monica, CA; Division of Dermatology,

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