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 S20 journal of clinical and aesthetic dermatology JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) 6 7.3%/45.5%; secukinumab 150mg with M TX: 71.7%/41.3%; and secukinumab 150mg without MTX: 57.4%/37.0%), regardless of concomitant MTX use. Additionally, improvements in PASI75/90 at Week 24 (secukinumab 300mg with MTX [n=14]: 35.7%/28.6%; and secukinumab 300mg without MTX [ n=27]: 77.8%/59.3%; secukinumab 150mg with MTX [n=22]: 59.1%/36.4%; and secukinumab 150mg without MTX [n=36]: 41.7%/30.6%) were sustained through Week 52 (secukinumab 300mg with MTX: 64.3%/35.7%; and secukinumab 300mg without MTX: 77.8%/66.7%; secukinumab 150mg with MTX: 63.6%/50.0%; and secukinumab 150mg without MTX: 52.8%/38.9%), regardless of concomitant MTX use. Improvements observed versus placebo at Week 24 in DAS28-CRP, HAQ-DI, SF-36 PCS and resolution of dactylitis and enthesitis were also sustained through 52 weeks, regardless of concomitant MTX use. Conclusion: Secukinumab 300 and 150mg improved joint and skin symptoms, physical function, and quality of life in patients with PsA through 52 weeks of therapy, in both the concomitant MTX and without MTX sub-groups. Reference: 1. Gottlieb AB, et al. EADV; Copenhagen, Denmark; 7–11 October 2015. e-Poster P0339. Financial diclosures/funding: This research was sponsored by Novartis Pharma AG, Basel, Switzerland. These results were originally presented at the 25th Annual Congress of the European Academy of Dermatology and Venereology, Austria, Vienna, September 28–October 2, 2016. Secukinumab is Effective in Subjects With Moderate to Severe Palmoplantar Psoriasis: 1.5 Year Results From the GESTURE Study P resenters: Gottlieb AB, 1 S ullivan J, 2 K ubanov A, 3 Tao A, 4 R egnault P, 5 F ox T, 5 Milutinovic M, 5 Frueh J 5 Affiliations: 1 New York Medical College, Valhalla, NY; 2 Holdsworth House Medical Practice, Darlinghurst, Australia; 3 State Scientific Center of Dermatology, Venereology and C osmetology, Moscow, Russia; 4 Novartis Pharmaceuticals Corporation, East Hanover, NJ; 5 Novartis Pharma AG, Basel, Switzerland Introduction: Palmoplantar psoriasis occurs in up to 40 percent of plaque psoriasis patients, and is often associated with pain, functional limitations, severe impact on patients' quality of life and resistance to treatment. Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has been shown to have significant efficacy in the treatment of moderate-to-severe psoriasis and psoriatic arthritis, demonstrating a rapid onset of action and sustained responses with a favorable safety profile. Here, we report 1.5 year (Week 80) efficacy and safety data from the GESTURE study in subjects with moderate-to-severe palmoplantar psoriasis treated with secukinumab. Methods: GESTURE is a double- blind, randomized, placebo-controlled, parallel-group, multicenter Phase 3b study. Subjects (N=205) were randomized 1:1:1 to receive secukinumab 300mg, secukinumab 150mg, or placebo, subcutaneously. At Week 16, subjects in the placebo arm who did not achieve a palmoplantar Investigator's Global Assessment (ppIGA) score of 0/1 (0=clear, 1=almost clear/minimal psoriasis of palms and soles) and at least 2 points reduction on ppIGA from Baseline were re- randomized 1:1 to receive secukinumab 300mg or 150mg. The primary objective o f GESTURE was to demonstrate s uperiority of secukinumab over placebo, as assessed by ppIGA 0/1 response at Week 16. Secondary objectives were the evaluation of ppIGA and palmoplantar Psoriasis Area and Severity Index (ppPASI) over time, and overall safety and tolerability of s ecukinumab. Results: The primary and secondary endpoints of this study were met. As previously reported, a third of subjects on secukinumab 300mg, and one fifth of those on 150mg achieved a ppIGA 0/1 response at Week 16 versus slightly over one percent for placebo (P<0.0001 and P=0.0002, respectively vs. placebo). ppIGA 0/1 responses were sustained and continued to improve out to Week 80: 57.2 and 34.9 percent in subjects treated with secukinumab 300mg and 150mg, respectively. Mean ppPASI reduction from baseline improved after Week 16 and reached -68.5 and -52.5 percent to Week 80 for secukinumab 300mg and 150mg, respectively. The most common adverse events across all treatment arms were nasopharyngitis, upper respiratory tract infection, and headache, similar to other pivotal secukinumab Phase 3 studies. Conclusion: GESTURE is the largest and longest duration randomized controlled trial to date in the difficult- to-treat palmoplantar psoriasis population. Results from GESTURE show that secukinumab displays significant efficacy in difficult-to-treat palmoplantar psoriasis with 6/10 subjects having clear/almost clear palms and soles after at 1.5 years. The safety profile was favorable and in line with the safety profile established in the large Phase 3 program. Financial diclosures/funding: This research was sponsored by Novartis Pharma AG, Basel, Switzerland.

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