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Literature DB >> 28819723

Guselkumab: First Global Approval.

Abstract

Guselkumab (Tremfya™) is a human monoclonal IgG1λ antibody being developed by Janssen Biotech, Inc. that has been approved in the USA as a treatment for moderate-to-severe plaque psoriasis. Guselkumab inhibits the binding of interleukin 23 (IL-23) to its cell surface receptor, disrupting the type 17 helper T cell/IL-17 pathway. This article summarizes the milestones in the development of guselkumab leading to this first approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Entities: Disease Gene Species

Mesh：

Substances：

Year: 2017 PMID： 28819723 DOI： 10.1007/s40265-017-0800-7

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

7 in total

1. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial.

Authors: R G Langley; T-F Tsai; S Flavin; M Song; B Randazzo; Y Wasfi; J Jiang; S Li; L Puig
Journal: Br J Dermatol Date: 2017-10-10 Impact factor: 9.302

2. A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis.

Authors: Kenneth B Gordon; Kristina Callis Duffin; Robert Bissonnette; Jörg C Prinz; Yasmine Wasfi; Shu Li; Yaung-Kaung Shen; Philippe Szapary; Bruce Randazzo; Kristian Reich
Journal: N Engl J Med Date: 2015-07-09 Impact factor: 91.245

3. Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis.

Authors: Howard Sofen; Stacy Smith; Robert T Matheson; Craig L Leonardi; Cesar Calderon; Carrie Brodmerkel; Katherine Li; Kim Campbell; Stanley J Marciniak; Yasmine Wasfi; Yuhua Wang; Philippe Szapary; James G Krueger
Journal: J Allergy Clin Immunol Date: 2014-04 Impact factor: 10.793

Review 4. Inhibition of interleukin-17, interleukin-23 and the TH17 cell pathway in the treatment of psoriatic arthritis and psoriasis.

Authors: Philip J Mease
Journal: Curr Opin Rheumatol Date: 2015-03 Impact factor: 5.006

5. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial.

Authors: Kristian Reich; April W Armstrong; Peter Foley; Michael Song; Yasmine Wasfi; Bruce Randazzo; Shu Li; Y-K Shen; Kenneth B Gordon
Journal: J Am Acad Dermatol Date: 2017-01-02 Impact factor: 11.527

6. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial.

Authors: Andrew Blauvelt; Kim A Papp; Christopher E M Griffiths; Bruce Randazzo; Yasmine Wasfi; Yaung-Kaung Shen; Shu Li; Alexa B Kimball
Journal: J Am Acad Dermatol Date: 2017-01-02 Impact factor: 11.527

7. First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis.

Authors: Yanli Zhuang; Cesar Calderon; Stanley J Marciniak; Esther Bouman-Thio; Philippe Szapary; Tong-Yuan Yang; Allen Schantz; Hugh M Davis; Honghui Zhou; Zhenhua Xu
Journal: Eur J Clin Pharmacol Date: 2016-08-11 Impact factor: 2.953

7 in total

10 in total

Review 1. Pathophysiology and inhibition of IL-23 signaling in psoriatic arthritis: A molecular insight.

Authors: Cuong Thach Nguyen; Yehudi Bloch; Katarzyna Składanowska; Savvas N Savvides; Iannis E Adamopoulos
Journal: Clin Immunol Date: 2018-09-06 Impact factor: 3.969

Review 2. IL-23/IL-17 Axis in Inflammatory Rheumatic Diseases.

Authors: Hao Li; George C Tsokos
Journal: Clin Rev Allergy Immunol Date: 2020-11-13 Impact factor: 8.667

Review 3. Regulation of host-microbe interactions at oral mucosal barriers by type 17 immunity.

Authors: Sarah L Gaffen; Niki M Moutsopoulos
Journal: Sci Immunol Date: 2020-01-03

Review 4. Role of the IL-23/IL-17 Axis in Psoriasis and Psoriatic Arthritis: The Clinical Importance of Its Divergence in Skin and Joints.

Authors: Marie-Astrid Boutet; Alessandra Nerviani; Gabriele Gallo Afflitto; Costantino Pitzalis
Journal: Int J Mol Sci Date: 2018-02-09 Impact factor: 5.923

Guselkumab: First Global Approval.

1. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial.

2. A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis.

3. Guselkumab (an IL-23-specific mAb) demonstrates clinical and molecular response in patients with moderate-to-severe psoriasis.

Review 4. Inhibition of interleukin-17, interleukin-23 and the TH17 cell pathway in the treatment of psoriatic arthritis and psoriasis.

6. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial.

7. First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis.

Review 1. Pathophysiology and inhibition of IL-23 signaling in psoriatic arthritis: A molecular insight.

Review 2. IL-23/IL-17 Axis in Inflammatory Rheumatic Diseases.

Review 3. Regulation of host-microbe interactions at oral mucosal barriers by type 17 immunity.

Review 4. Role of the IL-23/IL-17 Axis in Psoriasis and Psoriatic Arthritis: The Clinical Importance of Its Divergence in Skin and Joints.

Review 5. Tildrakizumab in the treatment of psoriasis: latest evidence and place in therapy.

Review 6. Spotlight on risankizumab and its potential in the treatment of plaque psoriasis: evidence to date.

Review 7. Guselkumab for the treatment of psoriasis - evidence to date.

8. Interleukin-12 and -23 blockade mitigates elastase-induced abdominal aortic aneurysm.

Review 9. Phage Display Technology as a Powerful Platform for Antibody Drug Discovery.

Review 10. Phage Display Derived Monoclonal Antibodies: From Bench to Bedside.