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 S28 journal of clinical and aesthetic dermatology JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) B iologic Therapies: an Integrated A nalysis of 2 Phase III Studies Presenters: Alice B. Gottlieb, 1 Sascha Gerdes, 2 Jean-Philippe Lacour, 3 Neil Korman, 4 Kim Papp, 5 Yves Dutronc, 6 Stefan Wilhelm, 6 Lotus Mallbris, 6 Lu Zhang, 6 Janelle Erickson, 6 Alexander Schacht, 6 Hervé B achelez 7 Affiliations: 1 Department of Dermatology, Tufts Medical Center, Boston, MA; 2 Psoriasis-Center at the Department of Dermatology, University Medical Center Schleswig- Holstein, Campus Kiel, Kiel, Germany; 3 Service de Dermatologie, Hôpital Archet-2, Nice, Cedex 3, France; 4 Murdough Family Center for Psoriasis, University Hospitals Case Medical Center, Cleveland, OH; 5 K. Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada; 6 Eli Lilly and Company, Indianapolis, IN; 7 Department of Dermatology, AP-HP Hôpital Saint- Louis, Paris, Cedex 10, France; Sorbonne Paris Cité Université Paris- Diderot, Paris, France Introduction: There is evidence that response rates to a biologic therapy may be lower in patients who have had previous exposure to other biologic therapies. Ixekizumab (IXE) is a high- affinity monoclonal antibody that selectively targets interleukin-17A (IL- 17A), approved for patients with moderate-to-severe psoriasis. In this integrated analysis, we evaluated the efficacy of IXE compared to etanercept (ETN) in patients who have or have not had previous exposure to biologic therapy. Methods: Data were integrated from the 12-week induction phase of two Phase 3 trials. Patients were randomized to one of the following treatment groups: IXE 80mg every two weeks (IXE Q2W; N=736) or four w eeks (IXE Q4W; N=733) following a 1 60mg starting dose, ETN 50mg twice weekly (N=740), or placebo (PBO; N=361). Psoriasis Area and Severity Index (PASI) 75, 90, and 100 response rates and Itch Numeric Rating Scale (NRS) were evaluated at Week 12 in subgroups of patients with or without p revious exposure to biologic therapy. Treatment effects within each subgroup were assessed using the Cochran-Mantel-Haenszel test stratified by study; missing values were imputed as nonresponse. Results: In this analysis, 497 (19.3%) patients had prior exposure to biologic therapy and 2,073 (80.7%) were naïve to biologic therapy. PASI 75 was achieved by 91.5 percent (biologic- experienced) and 87.7 percent (biologic-naïve) of patients treated with IXE Q2W, 76.2 and 82.2 percent treated with IXE Q4W, compared to 34.6 and 50.7 percent treated with ETN, respectively. PASI 90 was achieved by 76.1 percent (biologic- experienced) and 67.7 percent (biologic-naïve) of patients treated with IXE Q2W, 55.2 and 64.4 percent treated with IXE Q4W, and 13.2 and 24.3 percent treated with ETN. PASI 100 was achieved by 47.2 percent (biologic-experienced) and 37 percent (biologic-naïve) of patients treated with IXE Q2W, 25.2 and 34.9 percent treated with IXE Q4W, and 3.7 and seven percent treated with ETN (p<0.001 for all comparisons between IXE and ETN). At least 4 points of reduction in Itch NRS were achieved by 82.4 percent (biologic-experienced) and 84.1 percent (biologic-naïve) of patients from the IXE Q2W arm, 80.3 and 77.9 percent from the IXE Q4W arm, and 55.0 and 62.4 percent from the ETN arm. Conclusion: In this integrated analysis across two Phase 3 trials, both d oses of IXE were significantly s uperior to ETN for biologic-naïve and biologic-experienced patients. The IXE Q2W dosing regimen consistently provided greater efficacy relative to the IXE Q4W dosing regimen. Financial diclosures/funding: This study was sponsored by Eli Lilly and C ompany. Long-term Psoriasis Control Following Secukinumab Discontinuation Indicates Disease Modification of Moderate to Severe Psoriasis Presenters: Lebwohl M, 1 Iversen L, 2 Eidsmo L, 3 Messina I, 4 You R, 5 Milutinovic M 6 Affiliations: 1 Icahn School of Medicine at Mount Sinai, New York, NY; 2 Aarhus University Hospital, Aarhus, Denmark; 3 Karolinska University, Department of Medicine, Stockholm, Sweden; 4 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; 5 Shanghai Novartis Trading Ltd., Shanghai, China; 6 Novartis Pharma AG, Basel, Switzerland Introduction: Spontaneous psoriasis remissions are rare, especially in more severe disease. After treatment discontinuation, psoriasis tends to revert to its baseline severity. Methods: After one year of secukinumab treatment of moderate-to- severe psoriasis, PASI 75 responders continued double-blind secukinumab or switched to placebo (N=120). Upon relapse, placebo patients were retreated with secukinumab. Study of gene expression and histology was also conducted. Results: Following the last dose of secukinumab 300mg, 21 and 10 percent of patients did not relapse for at least 1 or 2 years, respectively. They maintained low mean PASI scores: 2.7

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