Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis
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TLDR
In three phase 3 trials involving patients with psoriasis, ixekizumab was effective through 60 weeks of treatment and the benefits need to be weighed against the risks of adverse events.Abstract:
BackgroundTwo phase 3 trials (UNCOVER-2 and UNCOVER-3) showed that at 12 weeks of treatment, ixekizumab, a monoclonal antibody against interleukin-17A, was superior to placebo and etanercept in the treatment of moderate-to-severe psoriasis. We report the 60-week data from the UNCOVER-2 and UNCOVER-3 trials, as well as 12-week and 60-week data from a third phase 3 trial, UNCOVER-1. MethodsWe randomly assigned 1296 patients in the UNCOVER-1 trial, 1224 patients in the UNCOVER-2 trial, and 1346 patients in the UNCOVER-3 trial to receive subcutaneous injections of placebo (placebo group), 80 mg of ixekizumab every 2 weeks after a starting dose of 160 mg (2-wk dosing group), or 80 mg of ixekizumab every 4 weeks after a starting dose of 160 mg (4-wk dosing group). Additional cohorts in the UNCOVER-2 and UNCOVER-3 trials were randomly assigned to receive 50 mg of etanercept twice weekly. At week 12 in the UNCOVER-3 trial, the patients entered a long-term extension period during which they received 80 mg of ixeki...read more
Citations
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Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics.
Alan Menter,Bruce Strober,Daniel H. Kaplan,Dario Kivelevitch,Elizabeth Farley Prater,Benjamin K. Stoff,April W. Armstrong,Cody Connor,Kelly M. Cordoro,Dawn Marie R. Davis,Boni E. Elewski,Joel M. Gelfand,Kenneth B. Gordon,Alice B. Gottlieb,Arthur Kavanaugh,Matthew Kiselica,Neil J. Korman,Daniela Kroshinsky,Mark Lebwohl,Craig L. Leonardi,Jason Lichten,Henry W. Lim,Nehal N. Mehta,Amy S. Paller,Sylvia L. Parra,Arun L. Pathy,Reena N. Rupani,Michael Siegel,Emily B. Wong,Jashin J. Wu,Vidhya Hariharan,Craig A. Elmets +31 more
TL;DR: The treatment of psoriasis with biologic agents will be reviewed, emphasizing treatment recommendations and the role of the dermatologist in monitoring and educating patients regarding benefits as well as associated risks.
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The immunology of atopic dermatitis and its reversibility with broad-spectrum and targeted therapies
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References
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Journal ArticleDOI
A distinct lineage of CD4 T cells regulates tissue inflammation by producing interleukin 17
Heon Park,Zhaoxia Li,Xuexian O. Yang,Seon Hee Chang,Roza Nurieva,Yi Hong Wang,Ying Wang,Leroy Hood,Zhou Zhu,Qiang Tian,Chen Dong +10 more
TL;DR: In vivo, antibody to IL- 17 inhibited chemokine expression in the brain during experimental autoimmune encephalomyelitis, whereas overexpression of IL-17 in lung epithelium caused Chemokine production and leukocyte infiltration, indicating a unique T helper lineage that regulates tissue inflammation.
Journal ArticleDOI
Mechanisms of Disease: Psoriasis.
TL;DR: Anti-TNF strategies have three variants: a humanized chimeric anti–TNF- α monoclonal antibody, a fully human monocolonal anti-T NF- α antibody, and a human p75 TNF-receptor Fc fusion protein.
Journal ArticleDOI
Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1)
Craig L. Leonardi,Alexa B. Kimball,Kim A. Papp,Newman Yeilding,Cynthia Guzzo,Y. Wang,Shu Li,Lisa T. Dooley,Kenneth B. Gordon +8 more
TL;DR: Ustekinumab seems to be efficacious for the treatment of moderate-to-severe psoriasis; dosing every 12 weeks maintains efficacy for at least a year in most patients.
Journal ArticleDOI
Secukinumab in plaque psoriasis--results of two phase 3 trials.
Richard G. Langley,Boni E. Elewski,Mark Lebwohl,Kristian Reich,Christopher E.M. Griffiths,Kim A. Papp,Lluís Puig,Hidemi Nakagawa,Lynda Spelman,Bárður Sigurgeirsson,Enrique Rivas,Tsen-Fang Tsai,Norman Wasel,Stephen K. Tyring,Thomas Salko,Isabelle Hampele,Marianne Notter,Alexander Karpov,Silvia Helou,Charis Papavassilis +19 more
TL;DR: Secukinumab was effective for psoriasis in two randomized trials, validating interleukin-17A as a therapeutic target and the rates of infection were higher with secuk inumab than with placebo in both studies and were similar to those with etanercept.
Journal ArticleDOI
Psoriasis causes as much disability as other major medical diseases.
TL;DR: Different aspects of psoriasis are related to the different dimensions of HRQL supporting the need for multidimensional treatment models, similar to that of other major medical diseases.
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