Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y [ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] S 1 8 s ecukinumab (300mg) or ustekinumab (per label, for subjects ≤100kg, 45mg; >100kg, 90mg). In both treatment arms, randomization was stratified by body weight (≤100 and > 100kg). Secukinumab was administered at baseline, Weeks 1, 2, 3, and 4, and then every four weeks from Week 8 to 48; ustekinumab at baseline and Week 4, then every 12 w eeks from Week 16 to 40. Exploratory objectives included assessing the effects of both treatments on health-related quality of life (HRQoL), including changes in the Dermatology Life Quality Index (DLQI; maximum range of 0–30), patient assessment of psoriasis symptoms (pain, itching, and scaling; using a numeric rating scale of 0–10), and, for subjects with psoriatic arthritis (PsA), the Health Assessment Questionnaire-disability index (HAQ- DI; maximum range of 0–3). Results: At each assessed time- point post baseline (Weeks 4, 8, 12, and 16), significantly more subjects achieved a DLQI score of 0 or 1 (i.e., no impact of skin problems on HRQoL) with secukinumab versus ustekinumab (at Week 16: 71.9 and 57.4%, respectively; P<0.0001). The total DLQI change from baseline (percentage and absolute change) was significantly greater with secukinumab versus ustekinumab at all time-points (P≤0.002). Improvements in psoriasis symptoms were greater for subjects on secukinumab at all time-points (Weeks 1, 2, 3, 4, 8, 12, and 16). At Week 16, subjects on secukinumab had mean decreases of 81 percent in pain, 79.5 percent in itching, and 86.3 percent in scaling scores, and these differences were significantly greater versus ustekinumab (P<0.05 for each). In subjects with PsA, the proportion achieving a decrease of at least 0.3 (minimum clinically important difference) in their HAQ-DI score was greater with secukinumab (34.9%) versus ustekinumab (26.5%). Conclusion: The superior 16-week efficacy of secukinumab versus ustekinumab in subjects with moderate-to-severe plaque psoriasis also translates into greater improvements in patient HRQoL. F inancial disclosures/funding: This research was funded by Novartis Pharma AG, Basel, Switzerland. Secukinumab Administration by P refilled Syringe Maintains Efficacy in Moderate-to-Severe Plaque Psoriasis Over 100 Weeks: Results of the FEATURE Trial Presenters: 1 Blauvelt A; 2 Gottlieb A B; 3 T yring S; 4 Y ou R; 5 P apanastasiou P; 5 Fox T; 5 Papavassilis C for the FEATURE Study Group Affiliations: 1 Oregon Medical Research Center, Portland, OR; 2 Tufts Medical Center, Boston, MA; 3 University of Texas Health Science Center/Center for Clinical Studies, Houston, TX; 4 Beijing Novartis Pharma Ltd., Shanghai, China; 5 Novartis Pharma AG, Basel, Switzerland Introduction and Objectives: Plaque psoriasis is a chronic disease; therefore, sustaining treatment benefits is important. Secukinumab, a human monoclonal antibody (mAb) that selectively targets interleukin (IL)-17A, has been demonstrated to be highly efficacious in the treatment of moderate-to-severe psoriasis, with a sustained effect and a favorable safety profile. The FEATURE study examined secukinumab efficacy and safety when self-administered using a prefilled syringe (PFS). Here, data from up to two years (100 weeks) of treatment are reported. Methods: In this Phase 3 trial, subjects were randomized 1:1:1 to secukinumab 300mg, 150mg, or placebo. Treatments were self- administered using a PFS at Weeks 0, 1, 2, 3, and 4, then every four weeks until Week 12 (placebo) or secukinumab until Week 208. Placebo group non-responders were re- randomized to secukinumab 300mg or 150mg after Week 12. Co-primary endpoints were secukinumab Psoriasis Area and Severity Index (PASI) 75 and Investigator's Global Assessment 2011 modified version (IGA mod 2011 0/1) clear/almost clear response rates at Week 12 compared to placebo. Secondary endpoints included PASI 90 and PASI 100. Here, Week 100 interim efficacy analyses were performed using multiple imputation (MI) methods on d ata from 86 subjects who received 300mg secukinumab and 88 subjects who received 150mg secukinumab at any point during the study. Results: Week 12 and 52 data were r eported previously. Secukinumab was superior to placebo at Week 12 with respect to PASI 75 response and IGA mod 2011 0/1 response, with substantial PASI 75, 90, and 100 r esponses maintained to Week 52. At Week 100, median treatment exposure at any dose was 624 (33–763) days for 274.3 subject-years overall experience. Week 100 analysis in all subjects receiving secukinumab from Week 0 or Week 13 showed PASI 90 response for 59.7 percent of subjects with 300mg and 41.3 percent with 150mg secukinumab. At Week 100, 40.8 and 22.2 percent of subjects had PASI 100 with secukinumab 300mg and 150mg, respectively. PASI 75 responses were seen in 79.6 percent of subjects with secukinumab 300mg and in 58.4 percent receiving secukinumab 150mg, and IGA mod 2011 0/1 scores were recorded for 55.2 and 41.1 percent of subjects receiving secukinumab 300mg and 150mg, respectively. No new or unexpected safety signals were observed to Week 100. Conclusion: Substantial and durable PASI 90 and PASI 100 responses at Week 100 were achieved using long-term administration of secukinumab by PFS. The safety profile of secukinumab was consistent with previous studies, with no new or cumulative safety findings seen. Financial disclosures/funding: This research was funded by Novartis Pharma AG, Basel, Switzerland. Secukinumab is Predominantly Prescribed at the Recommended 300mg Dose to Psoriasis Patients in the United States Presenters: 1 Jashin J. Wu; 2 Yang Zhao; 2 Yufeng Li; 2 Huanxue Zhou; 3 Xing Liu; 2 Melody Tran; 2 Vivian Herrera Affiliations: 1 Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA; 2 Novartis Pharmaceuticals Corporation, East Hanover, NJ; 3 KMK Consulting, Morristown, NJ Background: Secukinumab is a

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