Maintenance and Improvement of Skin Clearance Response With Brodalumab Among Patients With Moderate-to-Severe Psoriasis Neal D. Bhatia,1 Seemal R. Desai,2 Craig Teller,3 Abby Jacobson4 1Therapeutics Clinical Research, San Diego, CA; 2Innovative Dermatology, PA, Plano, TX, The University of Texas Southwestern Medical Center, Dallas, TX; 3Bellaire Dermatology, Bellaire, TX; 4Ortho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ 39th Annual Fall Clinical Dermatology Conference® for Dermatologists • October 17-20, 2019 • Las Vegas, NV INTRODUCTION • Brodalumab is a human anti–interleukin-17 receptor A monoclonal antibody that is efficacious in treating moderate-to-severe psoriasis1 • Maintenance of skin clearance among patients receiving brodalumab 210 mg subcutaneously every 2 weeks (Q2W) stratified by categories of psoriasis area and severity index (PASI) response at 12 weeks was previously assessed in two phase 3 studies (AMAGINE-2/-3) of adults with moderate- to-severe plaque psoriasis2 OBJECTIVE • To evaluate skin clearance response with brodalumab 210 mg Q2W through week 52 in the phase 3, double-blind, randomized, placebo- controlled AMAGINE-1 trial METHODS • Patients in AMAGINE-1 were initially randomized to brodalumab 210 mg Q2W or placebo for 12 weeks3 • After 12 weeks, those receiving brodalumab 210 mg Q2W who achieved static physician’s global assessment score of 0 or 1 (sPGA 0/1) were re-randomized to brodalumab 210 mg Q2W or placebo • Beginning at week 16, patients re-randomized to placebo who had return of disease, defined as sPGA ≥3, qualified for retreatment with their induction dose of brodalumab • 128 patients from AMAGINE-1 who received continuous brodalumab 210 mg Q2W through week 52 were included in this post hoc analysis comprising – 83 patients who were re-randomized to brodalumab 210 mg Q2W – 45 non–re-randomized patients who received brodalumab 210 mg Q2W after inadequate sPGA response • Skin clearance was monitored by categories of PASI response using nonresponder imputation RESULTS Week 12 PASI Responses • At week 12, among 128 patients who received continuous brodalumab 210 mg Q2W, 63% achieved PASI 90% improvement (PASI 90) or greater (37% achieved PASI 100 and 26% achieved PASI 90 to <100; Table 1) PASI Responses at Weeks 16, 28, and 52 • Among patients achieving PASI 100 at week 12, >75% maintained PASI 100 at weeks 16 and 28 – 81% maintained PASI 100 at week 16 – 77% maintained PASI 100 at week 28 • Among patients achieving PASI 100 at week 12, 79% maintained PASI 100 through week 52 • Notably, most patients (64%) who achieved PASI 90 to <100 at week 12 either improved to PASI 100 (49%) or maintained the same level of clearance (15%; Figure 1) at week 52 • Of patients who achieved PASI 75 to <90 at week 12, 43% experienced improvement at week 52 (19% improved to PASI 100 and 24% improved to PASI 90 to <100) Acknowledgments: This study was sponsored by Ortho Dermatologics. Medical writing support was provided by MedThink SciCom and funded by Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC. References: 1. Siliq [package insert]. Valeant Pharmaceuticals North America LLC; 2017. 2. Strober et al. Poster presented at: 76th Annual Meeting of the American Academy of Dermatology; February 16-20, 2018; San Diego, CA. 3. Papp et al. Br J Dermatol. 2016;175:273-286. © 2019. All Rights Reserved. Table 1. PASI Response at Week 12 in AMAGINE-1 3 6 9 15 49 18 Responses at week 52 among week 12 PASI 90 to <100 responders, % PASI <50 PASI 50 to <75 PASI 75 to <90 PASI 90 to <100 PASI 100 Othera Among PASI 90 to <100 responders at week 12, most (64%) improved to PASI 100 (49%) or maintained the same level of response (15%) Figure 1. PASI responses at week 52 among patients receiving brodalumab 210 mg Q2W who achieved PASI 90 to <100 at week 12. PASI, psoriasis area and severity index; Q2W, every 2 weeks. aOther includes 6 patients who discontinued before week 52 (n=2), those who received retreatment after return of disease (static physician’s global assessment score ≥3) at or after week 16 (n=3), and those with missing data (n=1). CONCLUSIONS • These data demonstrate maintenance and continued improvement of skin clearance through week 52 with brodalumab Response at week 12, n (%) Continuous brodalumab 210 mg Q2W (N=128) PASI 100 47 (37) PASI 90 to <100 33 (26) PASI 75 to <90 21 (16) PASI 50 to <75 11 (9) PASI <50 16 (13) PASI, psoriasis area and severity index; Q2W, every 2 weeks.