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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S21 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) T hese results were originally p resented at the 25th Annual Congress of the European Academy of Dermatology and Venereology, Austria, Vienna, September 28–October 2, 2016. Secukinumab Shows Significant Efficacy in Nail Psoriasis: Week 32 R esults From the TRANSFIGURE Study Presenters: Reich K, 1 Sullivan J, 2 Arenberger P, 3 Mrowietz U, 4 Jazayeri S, 5 Augustin M, 6 Parneix A, 7 Regnault P, 8 You R, 9 Milutinovic M 8 Affiliations: 1 Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany; 2 Holdsworth House Dermatology, Sydney, Australia; 3 Department of Dermatology, Charles University, Prague, Czech Republic; 4 Psoriasis Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany; 5 Alliance Dermatology and MOHS Center, Phoenix, Arizona; 6 Universität Hamburg, Hamburg, Germany; 7 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; 8 Novartis Pharma AG, Basel, Switzerland; 9 Beijing Novartis Pharma Co. Ltd, Shanghai, China Introduction: Nail psoriasis is associated with decreased finger mobility, functional impairment, pain, and reduced quality of life and is often resistant to therapies. It correlates with more severe psoriatic disease and is an important predictor of psoriatic arthritis. Lifetime incidence of nail psoriasis is as high as 90 percent. Secukinumab, a fully human monoclonal antibody that selectively targets IL-17A, is highly efficacious in the treatment of moderate-to-severe psoriasis, starting at early time points, with a sustained effect and a favorable safety profile. We assessed superiority o f secukinumab 300mg and/or 150mg v ersus placebo in treating subjects with moderate-to-severe psoriasis and significant nail involvement, as assessed by NAil Psoriasis Severity Index (NAPSI) at Week 16 and 32 and Psoriasis Area and Severity Index (PASI) change over time. Impact on q uality of life was assessed by Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) Patient Benefit Index (-PBI) and Quality of Life (-QOL) at Week 16. Methods: TRANSFIGURE is a double-blind, randomized, placebo- controlled, parallel-group, multicenter Phase 3b study. Subjects (N=198) were randomized 1:1:1 to receive secukinumab 300mg, secukinumab 150mg, or placebo, subcutaneously up to Week 128. At Week 16, all subjects receiving placebo were re-randomized 1:1 to receive 300mg or 150mg secukinumab. Results: The primary objective was met. Both doses of secukinumab were superior to placebo at Week 16 with a mean NAPSI improvement from baseline of -45.3, -37.9, and -10.8 percent for secukinumab 300mg, 150mg, and placebo, respectively (P<0.0001). Responses improved further by Week 32 with a NAPSI change of -63.2 and -52.6 percent for secukinumab 300mg and 150mg, respectively. At Week 32, PASI 90 responses were achieved in 72.1 and 61.4 percent of subjects, and PASI 100 responses in 36.9 and 28.1 percent for secukinumab 300mg and 150mg, respectively. At Week 16, subjects on secukinumab showed significant improvements in NAPPA-QOL with a median decrease in total score of 60.9, 49.9, and 15.8 percent for secukinumab 300mg, 150mg, and placebo, respectively. The percentage of subjects achieving a weighted NAPPA- P BI global score of ≥2 (at least m oderate benefits) was 75.4, 61.3, and 8.6 percent for secukinumab 300mg, 150mg, and placebo, respectively. The most common adverse events were nasopharyngitis, headache, and upper respiratory tract infections, similar to previous studies. C onclusion: In the prospective, placebo-controlled TRANSFIGURE trial, secukinumab demonstrated significant and clinically meaningful efficacy, quality-of-life improvement, and patient-reported benefit in nail psoriasis. Financial diclosures/funding: This research was sponsored by Novartis Pharma AG, Basel, Switzerland. These results were originally presented at the 17th Annual Congress of the European League Against Rheumatism, London, UK, June 8–11, 2016. Integrated Safety of Ixekizumab in Patients with Moderate-to-severe Psoriasis: Results from a Pooled Analysis of 7 Clinical Trials Presenters: Bruce Strober, 1 Kim A. Papp, 2 Craig Leonardi, 3 Robert Bissonette, 4 Laura Ferris, 5 Ulrich Mrowietz, 6 Mark Lebwohl, 7 Daniel K. Braun, 8 Nayan Acharya, 8 Wen Xu, 8 Kristian Reich 9 Affiliations: 1 University of Connecticut, Department of Dermatology, and Probity Medical Research, Farmington, CT; 2 K. Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada; 3 Saint Louis University; 4 Innovaderm Research, Montreal, QC, Canada; 5 UPMC Dept. of Dermatology, Pittsburgh, PA; 6 Department of Dermatology, University Medical Centre Schleswig-Holstein, Campus Kiel, Germany; 7 Department of Dermatology, Mount Sinai School

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