Importance of Complete Skin Clearance on Quality of Life: Analysis of Three Phase 3 Studies of Brodalumab April Armstrong,1 Andrew Blauvelt,2 Scott Drew,3 Roger Ho,4 Abby Jacobson5 1University of Southern California, Los Angeles, CA; 2Oregon Medical Research Center, Portland, OR; 3OhioHealth, Marion, OH; 4 The Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, NY; 5Ortho 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 • Complete skin clearance is an important treatment goal for patients with psoriasis1 • Evidence shows that complete skin clearance is associated with several benefits over almost-clear skin, including improved quality of life1 • Brodalumab is a human anti–interleukin-17 receptor A monoclonal antibody that is efficacious in treating moderate-to-severe psoriasis2-4 • In the phase 3 brodalumab trials AMAGINE-1, -2, and -3, 42%, 44%, and 37% of patients receiving brodalumab 210 mg every 2 weeks (Q2W), respectively, achieved a psoriasis area and severity index score of 100 (PASI 100) at week 122,3 OBJECTIVE • To explore whether patients with psoriasis achieving complete skin clearance experienced greater improvements in quality of life than those achieving a good but less-than-complete response METHODS • Data for this post hoc analysis were pooled from the nonplacebo groups of the 12-week induction phases of three phase 3 clinical trials (AMAGINE-1/-2/-3) of brodalumab in patients with moderate-to-severe plaque psoriasis • Patients included in the analysis were treated with brodalumab (140 or 210 mg) or ustekinumab (45 or 90 mg) and had achieved complete skin clearance, defined as 100% improvement in PASI score (PASI 100), or good but incomplete skin clearance, defined as PASI 90 to <100 • Patient-reported outcomes were used to evaluate quality of life (Figure 1), stratified by complete or good but incomplete skin clearance RESULTS • At week 12, mean (standard deviation [SD]) hospital anxiety and depression scale anxiety and depression scores were numerically lower for patients achieving PASI 100 (anxiety, 4.75 [3.30]; depression, 2.90 [3.00]) than for patients achieving PASI 90 to <100 (anxiety, 5.09 [4.16]; depression, 3.55 [3.18]; Figure 2) • Numerically fewer work limitations, indicated by mean (SD) work limitations questionnaire scores, were reported by patients achieving PASI 100 (2.29 [3.11]) than by those achieving PASI 90 to <100 (3.00 [3.58]; Figure 2) • At week 12, mean (SD) SF-36 mental component summary (MCS) and physical component summary (PCS) scores were similar among patients who achieved PASI 90 to <100 (MCS, 51.39 [7.68]; PCS, 52.53 [7.82]) and PASI 100 (MCS, 52.96 [7.99]; PCS, 52.38 [8.71]; Figure 3) 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. Takeshita et al. J Am Acad Dermatol. 2014;71:633-641. 2. Siliq [package insert]. Valeant Pharmaceuticals North America LLC; 2017. 3. Lebwohl et al. N Engl J Med. 2015;373:1318-1328. 4. Papp et al. Br J Dermatol. 2016;175:273-286. 5. Allaire. Arthritis Rheum. 2003;49(suppl 5S): S85-S89. 6. Grassi et al. Value Health. 2010;13:469-478. CONCLUSIONS • Achievement of complete skin clearance (PASI 100) was associated with greater numeric improvements in quality-of-life measures than achievement of a good but less-than-complete response in patients with moderate-to-severe plaque psoriasis • These results suggest that therapies likely to help patients achieve complete skin clearance, such as brodalumab, are important to consider when making treatment decisions © 2019. All Rights Reserved. SF-36 PCS scoreSF-36 MCS score HADS depression score WLQ HADS anxiety score Figure 1. Quality of life measures assessed in this post hoc analysis. Mean WLQ score Mean HADS depression score Mean HADS anxiety score 3.55 2.90 5.09 4.75 3.00 2.29 Greater anxiety, depression, or work impairment Less anxiety, depression, or work impairment Complete skin clearance (PASI 100) Good but incomplete response (PASI 90 to <100) Figure 2. Mean quality of life measure scores by categories of complete skin clearance (PASI 100) or good but incomplete response (PASI 90 to <100) at week 12. The HADS is a 14-item questionnaire, with higher scores indicating worse anxiety or depression.4 The WLQ measures on-the-job limitations due to health problems and health-related productivity loss, with higher scores indicating greater impairment.5 HADS, hospital anxiety and depression scale; PASI, psoriasis area and severity index; WLQ, work limitations questionnaire. 52.53 52.38 51.39 52.96 Better health Worse health Mean SF-36 Component Score MCS score PCS score Complete skin clearance (PASI 100) Good but incomplete response (PASI 90 to <100) Figure 3. Mean MCS and PCS scores by categories of complete skin clearance (PASI 100) or good but incomplete response (PASI 90 to <100) at week 12. SF-36 scores include 8 health domains yielding the MCS and PCS scores, with higher scores indicating better health.6 MCS, mental component summary; PASI, psoriasis area and severity index; PCS, physical component summary; SF-36, Short Form 36 health survey. HADS, hospital anxiety and depression scale; MCS, mental component summary; PCS, physical component summary; SF-36, Short Form 36 health survey; WLQ, work limitations questionnaire.