Secukinumab in plaque psoriasis--results of two phase 3 trials.

Mark Lebwohl, Christopher E M Griffiths, Lluís Puig, Hidemi Nakagawa, Bárður Sigurgeirsson, Thomas Salko, Isabelle Hampele, Marianne Notter, Alexander Karpov, Silvia Helou, Charis Papavassilis, Ricardo Galimberti (Collaborator), Viviana Parra (Collaborator), Ignacio Dei Cas (Collaborator), Nora Kogan (Collaborator), Kim Papp (Collaborator), Ronald B Vender (Collaborator), Marc Bourcier (Collaborator), David Gratton (Collaborator), Melinda Gooderham (Collaborator)Esperanza Melendez (Collaborator), Antonio Jaller (Collaborator), William Otero (Collaborator), Carolina Cortes (Collaborator), Külli Kingo (Collaborator), Pille Konno (Collaborator), Kristi Pender (Collaborator), Kairi Nurm (Collaborator), Bardur Sigurgeirsson (Collaborator), Michael Ziv (Collaborator), Lev Pavlovsky (Collaborator), Felix Pavlotsky (Collaborator), Hidehisa Saeki (Collaborator), Yukari Okubo (Collaborator), Akimichi Morita (Collaborator), Hajime Iizuka (Collaborator), Takafumi Etoh (Collaborator), Yoshihide Asano (Collaborator), Keiichiro Hori (Collaborator), Tsunao Ohi (Collaborator), Yoshihiro Sei (Collaborator), Juichiro Nakayama (Collaborator), Norito Katoh (Collaborator), Osamu Nemoto (Collaborator), Atsuyuki Igarashi (Collaborator), Takashi Hashimoto (Collaborator), Masatoshi Abe (Collaborator), Yujiro Takae (Collaborator), Akihiko Asahina (Collaborator), Tomotaka Mabuchi (Collaborator), Tatjana Demidova (Collaborator), Ingmars Mikazans (Collaborator), Raimonds Karls (Collaborator), Marcis Septe (Collaborator), Sigitas Stonkus (Collaborator), Skaidra Valiukeviciene (Collaborator), Redzinalda Narbutas (Collaborator), Matilda Bylaite (Collaborator), Jose Barba (Collaborator), Jorge Ocampo (Collaborator), Gladys Léon Dorantes (Collaborator), César Maldonado (Collaborator), Chic-Jung Hsu (Collaborator), Tsen-Fang Tsai (Collaborator), Nan-Lin Wu (Collaborator), Marta Hampton (Collaborator), James Krell (Collaborator), Phoebe Rich (Collaborator), Andrew Blauvelt (Collaborator), David Pariser (Collaborator), Sandra Adsit (Collaborator), Stephanie Takahashi (Collaborator), Howard Sofen (Collaborator), Elizabeth Tichy (Collaborator), Jennifer Cather (Collaborator), Stephen Tyring (Collaborator), Michael Jarratt (Collaborator), Terry Jones (Collaborator), John Tu (Collaborator), Leon Kircik (Collaborator), Joel Gelfand (Collaborator), Yolanda Helfrich (Collaborator), Leonard Swinyer (Collaborator), Alan Kivitz (Collaborator), David Horowitz (Collaborator), Paul Klas (Collaborator), Boni Elewski (Collaborator), Jonathan Weiss (Collaborator), Joel Schlessinger (Collaborator), Joseph Samady (Collaborator), Alan Menter (Collaborator), Sasha Jazayeri (Collaborator), Jeffrey Moore (Collaborator), Ellen Marmur (Collaborator), Joseph Fowler (Collaborator), Michael Giessel (Collaborator), Brian Sperber (Collaborator), Chouela Edgardo (Collaborator), Hugo Cabrera (Collaborator), Éduardo Rodriguez (Collaborator), Gabriel Magariños (Collaborator), Galimberti Ricardo (Collaborator), Parra Viviana (Collaborator), Rod Sinclair (Collaborator), Peter Foley (Collaborator), Lynda Spelman (Collaborator), Stephen Shumack (Collaborator), Arjen Fokko Nikkels (Collaborator), Pierre-Dominique Ghislain (Collaborator), Diane Roseeuw (Collaborator), U Z Gent (Collaborator), Jo Lambert (Collaborator), Yves Poulin (Collaborator), Richard Langley (Collaborator), Lorne Albrecht (Collaborator), Charles Lynde (Collaborator), Vincent Ho (Collaborator), Norman Wasel (Collaborator), Mani Raman (Collaborator), Cesar Gonzalez (Collaborator), Elkin Peñaranda (Collaborator), Ashraf Hamza (Collaborator), Sakari Reitamo (Collaborator), Leena Koulu (Collaborator), Mireille Ruer-Mulard (Collaborator), Jean-Jaques Grob (Collaborator), Carle Paul (Collaborator), Jean-Paul Ortonne (Collaborator), Marie Beylot (Collaborator), Ziad Reguiai (Collaborator), Herve Bachelez (Collaborator), Sandra Philip (Collaborator), Christine Grigat (Collaborator), Erika Zahn (Collaborator), Johannes Niesmann (Collaborator), Rotraut Mößner (Collaborator), Hans Michael Ockefels (Collaborator), Rudolf Herbst (Collaborator), Assaf Chalid (Collaborator), Kowalzick Lutz (Collaborator), Sylvia Pauser (Collaborator), Maurizio Podda (Collaborator), Erwin Schultz (Collaborator), Rolf-Markus Szeimies (Collaborator), Liebhild Stratmann (Collaborator), Christine Paschen (Collaborator), Popp Georg (Collaborator), Swarna Ekanayake-Bohlig (Collaborator), Margrit Simon (Collaborator), Kristian Reich (Collaborator), Martin Kaatz (Collaborator), Isaak Effendy (Collaborator), Stephan Weidinger (Collaborator), Ingo Haase (Collaborator), Thomas Dirschka (Collaborator), Diamant Thaci (Collaborator), Dagmar Wilsmann-Theis (Collaborator), Michael Sticherling (Collaborator), Knut Schäkel (Collaborator), Ulrich Mrowietz (Collaborator), Thomas Luger (Collaborator), Sigrid Karrer (Collaborator), Tilo Biedermann (Collaborator), Gottfried Wozel (Collaborator), Lutze Stine (Collaborator), Dirk Schadendorf (Collaborator), Gerardo Bran (Collaborator), Miriam Azucena Hernandez (Collaborator), Anthony Bewley (Collaborator), Maria del Pilar Manrique (Collaborator), Enrique Rivas (Collaborator), Pablo Urquizu (Collaborator), Éva Remenyik (Collaborator), Adrienne Vajda (Collaborator), Zita Battyani (Collaborator), Enikő Telegdy (Collaborator), Eva Apostol (Collaborator), Zsuzsánna Károlyi (Collaborator), Lajos Kemény (Collaborator), Ali Mir Mubashir (Collaborator), Ramesh Bhat (Collaborator), Gopal Maragondanahalli (Collaborator), Rachita Dhurat (Collaborator), Leelavathy Budamakuntla (Collaborator), Srinivas Putta (Collaborator), Sandesh Gupta (Collaborator), Sushil Pande (Collaborator), Sacchidanand Sarvajanamurthy Aradhya (Collaborator), Cristina Magnoni (Collaborator), Concetta Potenza (Collaborator), Ketty Peris (Collaborator), Giuseppe Micali (Collaborator), Fabio Ayala (Collaborator), Belen Dofitas (Collaborator), Jane Mendinueto-Salvador (Collaborator), Joanna Narbutt (Collaborator), Zygmunt Adamski (Collaborator), Jacek Szepietowski (Collaborator), Andrzej Kaszuba (Collaborator), Marcela Poenaru (Collaborator), Rozalia Olsavszky (Collaborator), Liliana Cavaropol (Collaborator), Calin Giurceanu (Collaborator), Derrick Aw (Collaborator), Jee-Ho Choi (Collaborator), Jeung-Hoon Lee (Collaborator), Seungchul Lee (Collaborator), Seong Jun Seo (Collaborator), Kwang-Joong Kim (Collaborator), Yongbeom Choe (Collaborator), Moon-Bum Kim (Collaborator), Joo-Heung Lee (Collaborator), Min-Geol Lee (Collaborator), Tae Yoon Kim (Collaborator), Francisco Vanaclocha (Collaborator), Luis Puig (Collaborator), Jose Sanchez Carazo (Collaborator), Pablo De la cueva Dobao (Collaborator), Rúben Del Rio Gil (Collaborator), Natalia Fernandez Chico (Collaborator), Marie Virtanen (Collaborator), Tomas Eriksson (Collaborator), Ingela Flytström (Collaborator), Åke Svensson (Collaborator), Ben Walker (Collaborator), Urszula Brudnik (Collaborator), John Berth-Jones (Collaborator), Evmorfia Ladoyanni (Collaborator), Christopher Griffiths (Collaborator), Rachel Wachsmuth (Collaborator), Kyle Wagaman (Collaborator), Ellen Frankel (Collaborator), Scott Fretzin (Collaborator), Russell Mader (Collaborator), Steven Davis (Collaborator), Zoe Draelos (Collaborator), Michelle Pelle (Collaborator), David M Pariser (Collaborator), Norman Bystol (Collaborator), Stephen Miller (Collaborator), Marie Beylot Barry (Collaborator), Dattatray Saple (Collaborator), Bárour Sigurgeirsson

    Research output: Contribution to journalArticlepeer-review


    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
    Original languageEnglish
    Pages (from-to)326-338
    Number of pages12
    JournalThe New England Journal of Medicine
    Issue number4
    Publication statusPublished - 24 Jul 2014


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