1. Secukinumab in Plaque Psoriasis - Results of Two Phase 3 Trials
- Author
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Langley, Rg, Elewski, Be, Lebwohl, M, Reich, K, Griffiths, Ce, Papp, K, Puig, L, Nakagawa, H, Spelman, L, Sigurgeirsson, B, Rivas, E, Tsai, Tf, Wasel, N, Tyring, S, Salko, T, Hampele, I, Notter, M, Karpov, A, Helou, S, Papavassilis, C, ERASURE Study Group, FIXTURE Study Group, and Potenza, C
- Subjects
Male ,Receptors, Tumor Necrosis Factor ,Etanercept ,030207 dermatology & venereal diseases ,0302 clinical medicine ,0303 health sciences ,mechanisms ,Risankizumab ,pathogenesis ,Interleukin-17 ,Antibodies, Monoclonal ,General Medicine ,Middle Aged ,3. Good health ,T-cells ,double-blind ,interleukin-17 ,distinct ,disease ,lineage ,life ,Female ,Immunosuppressive Agents ,medicine.drug ,Adult ,medicine.medical_specialty ,Injections, Subcutaneous ,Tildrakizumab ,Placebo ,Antibodies, Monoclonal, Humanized ,Infections ,Antibodies ,03 medical and health sciences ,Double-Blind Method ,Psoriasis ,Internal medicine ,medicine ,Humans ,030304 developmental biology ,business.industry ,medicine.disease ,Dermatology ,Immunoglobulin A ,Ixekizumab ,Guselkumab ,Immunoglobulin G ,Secukinumab ,business - Abstract
BACKGROUND: Interleukin-17A is considered to be central to the pathogenesis of psoriasis. We evaluated secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe plaque psoriasis. METHODS: In two phase 3, double-blind, 52-week trials, ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), we randomly assigned 738 patients (in the ERASURE study) and 1306 patients (in the FIXTURE study) to subcutaneous secukinumab at a dose of 300 mg or 150 mg (administered once weekly for 5 weeks, then every 4 weeks), placebo, or (in the FIXTURE study only) etanercept at a dose of 50 mg (administered twice weekly for 12 weeks, then once weekly). The objective of each study was to show the superiority of secukinumab over placebo at week 12 with respect to the proportion of patients who had a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) and a score of 0 (clear) or 1 (almost clear) on a 5-point modified investigator's global assessment (coprimary end points). RESULTS: The proportion of patients who met the criterion for PASI 75 at week 12 was higher with each secukinumab dose than with placebo or etanercept: in the ERASURE study, the rates were 81.6% with 300 mg of secukinumab, 71.6% with 150 mg of secukinumab, and 4.5% with placebo; in the FIXTURE study, the rates were 77.1% with 300 mg of secukinumab, 67.0% with 150 mg of secukinumab, 44.0% with etanercept, and 4.9% with placebo (P
- Published
- 2014