Literature DB >> 25648267

Secukinumab: first global approval.

Mark Sanford1, Kate McKeage.   

Abstract

Secukinumab (Cosentyx™) is a fully human monoclonal antibody against interleukin-17A, formulated for intravenous and subcutaneous administration. It received its first global approval in Japan on 26 December 2014 for the treatment of psoriasis and psoriatic arthritis in adults who are not adequately responding to systemic therapies (except for biologic agents). In the USA and the EU, secukinumab was approved in early 2015 for the treatment of patients with moderate-to-severe plaque psoriasis. Secukinumab is also being investigated in patients with ankylosing spondylitis and rheumatoid arthritis. This article summarizes the milestones in the development of secukinumab leading to its first approval for the treatment of adult patients with psoriasis and psoriatic arthritis.

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Year:  2015        PMID： 25648267     DOI： 10.1007/s40265-015-0359-0

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  15 in total

1.  Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial.

Authors:  Wolfgang Hueber; Bruce E Sands; Steve Lewitzky; Marc Vandemeulebroecke; Walter Reinisch; Peter D R Higgins; Jan Wehkamp; Brian G Feagan; Michael D Yao; Marek Karczewski; Jacek Karczewski; Nicole Pezous; Stephan Bek; Gerard Bruin; Bjoern Mellgard; Claudia Berger; Marco Londei; Arthur P Bertolino; Gervais Tougas; Simon P L Travis
Journal:  Gut       Date:  2012-05-17       Impact factor: 23.059

2.  Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials.

Authors:  Andrew D Dick; Ilknur Tugal-Tutkun; Stephen Foster; Manfred Zierhut; S H Melissa Liew; Vladimir Bezlyak; Sofia Androudi
Journal:  Ophthalmology       Date:  2013-01-03       Impact factor: 12.079

3.  Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study.

Authors:  Mark C Genovese; Patrick Durez; Hanno B Richards; Jerzy Supronik; Eva Dokoupilova; Vadim Mazurov; Jacob A Aelion; Sang-Heon Lee; Christine E Codding; Herbert Kellner; Takashi Ikawa; Sophie Hugot; Shephard Mpofu
Journal:  Ann Rheum Dis       Date:  2012-06-23       Impact factor: 19.103

Review 4.  The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials.

Authors:  Richard G B Langley; Steven R Feldman; Judit Nyirady; Peter van de Kerkhof; Charis Papavassilis
Journal:  J Dermatolog Treat       Date:  2013-12-20       Impact factor: 3.359

5.  Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE).

Authors:  A Blauvelt; J C Prinz; A B Gottlieb; K Kingo; H Sofen; M Ruer-Mulard; V Singh; R Pathan; C Papavassilis; S Cooper
Journal:  Br J Dermatol       Date:  2014-12-11       Impact factor: 9.302

6.  Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study.

Authors:  Mamitaro Ohtsuki; Akimichi Morita; Masatoshi Abe; Hidetoshi Takahashi; Noriko Seko; Alexander Karpov; Tomohiro Shima; Charis Papavassilis; Hidemi Nakagawa
Journal:  J Dermatol       Date:  2014-10-30       Impact factor: 4.005

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

Authors:  Richard G Langley; Boni E Elewski; Mark Lebwohl; Kristian Reich; Christopher E M Griffiths; Kim Papp; Lluís Puig; Hidemi Nakagawa; Lynda Spelman; Bárður Sigurgeirsson; Enrique Rivas; Tsen-Fang Tsai; Norman Wasel; Stephen Tyring; Thomas Salko; Isabelle Hampele; Marianne Notter; Alexander Karpov; Silvia Helou; Charis Papavassilis
Journal:  N Engl J Med       Date:  2014-07-09       Impact factor: 91.245

8.  Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study.

Authors:  P Rich; B Sigurgeirsson; D Thaci; J-P Ortonne; C Paul; R E Schopf; A Morita; K Roseau; E Harfst; A Guettner; M Machacek; C Papavassilis
Journal:  Br J Dermatol       Date:  2013-02       Impact factor: 9.302

9.  Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds.

Authors:  Vibeke Strand; Mark Kosinski; Ari Gnanasakthy; Usha Mallya; Shephard Mpofu
Journal:  Health Qual Life Outcomes       Date:  2014-03-05       Impact factor: 3.186

Review 10.  Targeting of interleukin-17 in the treatment of psoriasis.

Authors:  Ann Sophie Lønnberg; Claus Zachariae; Lone Skov
Journal:  Clin Cosmet Investig Dermatol       Date:  2014-09-15
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  26 in total

1.  Gut-Busters: IL-17 Ain't Afraid of No IL-23.

Authors:  Natasha Whibley; Sarah L Gaffen
Journal:  Immunity       Date:  2015-10-20       Impact factor: 31.745

Review 2.  Secukinumab: a promising therapeutic option in spondyloarthritis.

Authors:  Hernan Maldonado-Ficco; Rodolfo Perez-Alamino; José A Maldonado-Cocco
Journal:  Clin Rheumatol       Date:  2016-07-20       Impact factor: 2.980

3.  CCAAT/Enhancer-binding protein β promotes pathogenesis of EAE.

Authors:  Michelle R Simpson-Abelson; Gerard Hernandez-Mir; Erin E Childs; J Agustin Cruz; Amanda C Poholek; Ansuman Chattopadhyay; Sarah L Gaffen; Mandy J McGeachy
Journal:  Cytokine       Date:  2017-01-12       Impact factor: 3.861

Review 4.  Beyond Candida albicans: Mechanisms of immunity to non-albicans Candida species.

Authors:  Natasha Whibley; Sarah L Gaffen
Journal:  Cytokine       Date:  2015-08-11       Impact factor: 3.861

Review 5.  Biological therapies for the treatment of Behçet's disease-related uveitis beyond TNF-alpha blockade: a narrative review.

Authors:  Jurgen Sota; Donato Rigante; Giuseppe Lopalco; Bruno Frediani; Rossella Franceschini; Mauro Galeazzi; Florenzo Iannone; Gian Marco Tosi; Claudia Fabiani; Luca Cantarini
Journal:  Rheumatol Int       Date:  2017-07-27       Impact factor: 2.631

6.  IL-17 Receptor Signaling in Oral Epithelial Cells Is Critical for Protection against Oropharyngeal Candidiasis.

Authors:  Heather R Conti; Vincent M Bruno; Erin E Childs; Sean Daugherty; Joseph P Hunter; Bemnet G Mengesha; Danielle L Saevig; Matthew R Hendricks; Bianca M Coleman; Lucas Brane; Norma Solis; J Agustin Cruz; Akash H Verma; Abhishek V Garg; Amy G Hise; Jonathan P Richardson; Julian R Naglik; Scott G Filler; Jay K Kolls; Satrajit Sinha; Sarah L Gaffen
Journal:  Cell Host Microbe       Date:  2016-10-27       Impact factor: 21.023

7.  MCPIP1/Regnase-1 Restricts IL-17A- and IL-17C-Dependent Skin Inflammation.

Authors:  Leticia Monin; Johann E Gudjonsson; Erin E Childs; Nilesh Amatya; Xianying Xing; Akash H Verma; Bianca M Coleman; Abhishek V Garg; Meaghan Killeen; Alicia Mathers; Nicole L Ward; Sarah L Gaffen
Journal:  J Immunol       Date:  2016-12-05       Impact factor: 5.422

Review 8.  Interleukin 17 Family Cytokines: Signaling Mechanisms, Biological Activities, and Therapeutic Implications.

Authors:  Leticia Monin; Sarah L Gaffen
Journal:  Cold Spring Harb Perspect Biol       Date:  2018-04-02       Impact factor: 10.005

Review 9.  Secukinumab: A New Treatment Option for Psoriatic Arthritis.

Authors:  Philip Mease; Iain B McInnes
Journal:  Rheumatol Ther       Date:  2016-04-23

10.  Development of tibulizumab, a tetravalent bispecific antibody targeting BAFF and IL-17A for the treatment of autoimmune disease.

Authors:  Robert J Benschop; Chi-Kin Chow; Yu Tian; James Nelson; Barbra Barmettler; Shane Atwell; David Clawson; Qing Chai; Bryan Jones; Jon Fitchett; Stacy Torgerson; Yan Ji; Holly Bina; Ningjie Hu; Mahmoud Ghanem; Joseph Manetta; Victor J Wroblewski; Jirong Lu; Barrett W Allan
Journal:  MAbs       Date:  2019-06-10       Impact factor: 5.857
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