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 S18 journal of clinical and aesthetic dermatology JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) a pplication-site reactions, and were m ore likely associated with the tazarotene component. Side effects, such as skin atrophy, were rare. Conclusion: HP/TAZ lotion was consistently more effective than its monads or vehicle in achieving treatment success and reducing p soriasis signs of erythema, plaque elevation, and scaling at the target lesion. Safety data were consistent with the known safety profile of halobetasol propionate and tazarotene and did not reveal any new safety concerns with the combination product. Secukinumab Demonstrates Sustained High Efficacy and a Favorable Safety Profile in Moderate to Severe Psoriasis Patients Through 4-Years of Treatment (Extension of the SCULPTURE Study) Presenters: Bissonnette R, 1 Luger T, 2 Thaçi D, 3 Toth D, 4 Letzelter K, 5 Xia S, 6 Mazur R, 5 Milutinovic M, 5 Leonardi C 7 Affiliations: 1 Innovaderm Research, Montreal, Canada; 2 Department of Dermatology, University of Mü nster, Albert-Schweitzer-Campus, Mü nster, Germany; 3 Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lü beck, Germany; 4 Department of Geriatric and Environmental Dermatology, Probity Medical Research Windsor and XLR8 Medical Research, Windsor, Ontario, Canada; 5 Novartis Pharma AG, Basel, Switzerland; 6 Beijing Novartis Pharma Co. Ltd., Shanghai, China; 7 Department of Dermatology, Saint Louis University Health Science Center, St. Louis Introduction: Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has demonstrated significant efficacy in moderate-to-severe psoriasis and p soriatic arthritis, demonstrating a r apid onset of action and sustained responses with a favorable safety profile. In previously reported results from SCULPTURE, Psoriasis Area and Severity Index (PASI) 90/100 response rates with fixed-interval secukinumab 300mg were 64%/43% at Week 104 and 6 4%/43% at Week 152. This analysis is the first Phase 3 study of an interleukin-17A inhibitor to evaluate the efficacy and safety up to four years at the approved dose. Methods: In SCULPTURE, PASI 75 responders at Week 12 were randomized to a double-blind maintenance treatment of subcutaneous secukinumab 300mg or 150mg, administered at a four-week fixed-interval or in a retreatment-as- needed regimen. Patients who completed 52 weeks of treatment continued into the extension and received the same blinded maintenance treatment regimen and dose up to end of Year 3. In the fourth year, the study was open-label, with treatment mainly self-injected by patients at home. Results: Secukinumab 300mg (fixed- interval dosing) demonstrated sustained efficacy over four years of treatment in patients (Baseline: n=168, Year 1: n=165, and Year 4: n=131) with moderate-to-severe psoriasis (mean baseline PASI: 23.5 ± 8.8; mean baseline body surface area: 33.1%±18.9). Approximately two-thirds of patients had clear or almost clear skin (PASI 90) at Year 1 (68.5%), a response rate which was sustained to Year 4 (66.4%). The proportion of patients with clear skin (PASI 100) at Year 1 (43.8%) was also sustained to Year 4 (43.5%; Figure). The median percentage change in PASI from Baseline to Year 1 (98.4%) was maintained to Year 4 (97.8%). PASI ≤1/≤2/≤3 responses at Year 1 were 58.6, 67.9, and 74.1 percent, respectively, and w ere 58.8, 71, and 77.1 percent, r espectively, at Year 4. Dermatology Quality of Life Index 0/1 response (representing no impact of skin problems on patients' lives) was sustained over four years (Year 1: 72.7%, Year 4: 70.8%). The safety profile of secukinumab remained favorable y ear-on-year up to four years, with no cumulative or unexpected safety concerns. The most common adverse events were nasopharyngitis and upper respiratory tract infection, similar to the pivotal one-year clinical studies. Conclusion: Secukinumab 300mg delivered high and sustained levels of skin clearance up to four years in patients with moderate-to-severe psoriasis. Secukinumab also led to high and sustained relief from the burden of psoriasis on patients' lives. Favorable safety established in a large Phase 3 program was maintained to four years, with no increase of adverse events year-on-year and no new or unexpected safety signals. 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 300mg is More Efficacious than Ustekinumab 90mg: Analysis of the CLEAR Study Presenters: Herránz Pinto P, 1 Rivera R, 2 Blauvelt A, 3 Thaci D, 4 Oliver Vigueras J 5 Affiliations: 1 Hospital La Paz, Madrid, Spain; 2 Hospital 12 de Octubre, Madrid, Spain; 3 Medical Research Center, Portland, Oregon; 4 University Hospital Schleswig-Holstein, Campus Lü beck, Germany; 5 Novartis Pharma

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