Literature DB >> 27577550

Brodalumab: First Global Approval.

Sarah L Greig1.   

Abstract

Brodalumab (Lumicef(®)) is a human monoclonal immunoglobulin G antibody that is being developed by Kyowa Hakko Kirin in Japan, where it has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. Brodalumab binds with high affinity to interleukin (IL)-17 receptor A, thereby inhibiting several pro-inflammatory cytokines from the IL-17 family. Regulatory applications for brodalumab in plaque psoriasis are also under review in the USA, EU and Canada. This article summarizes the milestones in the development of brodalumab leading to this first approval for the treatment of psoriasis.

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Year:  2016        PMID： 27577550     DOI： 10.1007/s40265-016-0634-8

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


  14 in total

1.  Anti-IL-17 receptor antibody AMG 827 leads to rapid clinical response in subjects with moderate to severe psoriasis: results from a phase I, randomized, placebo-controlled trial.

Authors:  Kim A Papp; Cathy Reid; Peter Foley; Rod Sinclair; David H Salinger; Gary Williams; Hua Dong; James G Krueger; Chris B Russell; David A Martin
Journal:  J Invest Dermatol       Date:  2012-05-24       Impact factor: 8.551

2.  A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis.

Authors:  K A Papp; K Reich; C Paul; A Blauvelt; W Baran; C Bolduc; D Toth; R G Langley; J Cather; A B Gottlieb; D Thaçi; J G Krueger; C B Russell; C E Milmont; J Li; P A Klekotka; G Kricorian; A Nirula
Journal:  Br J Dermatol       Date:  2016-06-23       Impact factor: 9.302

3.  Population pharmacokinetics of brodalumab in healthy adults and adults with psoriasis from single and multiple dose studies.

Authors:  Christopher J Endres; David H Salinger; Kathleen Köck; Marc R Gastonguay; David A Martin; Paul Klekotka; Ajay Nirula; Megan A Gibbs
Journal:  J Clin Pharmacol       Date:  2014-05-27       Impact factor: 3.126

4.  Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis.

Authors:  Mark Lebwohl; Bruce Strober; Alan Menter; Kenneth Gordon; Jolanta Weglowska; Lluis Puig; Kim Papp; Lynda Spelman; Darryl Toth; Francisco Kerdel; April W Armstrong; Georg Stingl; Alexa B Kimball; Herve Bachelez; Jashin J Wu; Jeffrey Crowley; Richard G Langley; Tomasz Blicharski; Carle Paul; Jean-Philippe Lacour; Stephen Tyring; Leon Kircik; Sergio Chimenti; Kristina Callis Duffin; Jerry Bagel; John Koo; Gary Aras; Joanne Li; Wenjie Song; Cassandra E Milmont; Yifei Shi; Ngozi Erondu; Paul Klekotka; Brian Kotzin; Ajay Nirula
Journal:  N Engl J Med       Date:  2015-10       Impact factor: 91.245

5.  Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis.

Authors:  Kim A Papp; Craig Leonardi; Alan Menter; Jean-Paul Ortonne; James G Krueger; Gregory Kricorian; Girish Aras; Juan Li; Chris B Russell; Elizabeth H Z Thompson; Scott Baumgartner
Journal:  N Engl J Med       Date:  2012-03-29       Impact factor: 91.245

Review 6.  Use of brodalumab for the treatment of psoriasis and psoriatic arthritis.

Authors:  Dario N Kivelevitch; Alan Menter
Journal:  Immunotherapy       Date:  2015       Impact factor: 4.196

7.  A semi-mechanistic model to characterize the pharmacokinetics and pharmacodynamics of brodalumab in healthy volunteers and subjects with psoriasis in a first-in-human single ascending dose study.

Authors:  David H Salinger; Christopher J Endres; David A Martin; Megan A Gibbs
Journal:  Clin Pharmacol Drug Dev       Date:  2014-02-18

8.  Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis.

Authors:  Philip J Mease; Mark C Genovese; Maria W Greenwald; Christopher T Ritchlin; André D Beaulieu; Atul Deodhar; Richard Newmark; JingYuan Feng; Ngozi Erondu; Ajay Nirula
Journal:  N Engl J Med       Date:  2014-06-12       Impact factor: 91.245

9.  Gene expression profiles normalized in psoriatic skin by treatment with brodalumab, a human anti-IL-17 receptor monoclonal antibody.

Authors:  Chris B Russell; Hugh Rand; Jeannette Bigler; Keith Kerkof; Martin Timour; Edgar Bautista; James G Krueger; David H Salinger; Andrew A Welcher; David A Martin
Journal:  J Immunol       Date:  2014-03-19       Impact factor: 5.422

Review 10.  Brodalumab for the Treatment of Psoriasis: A Review of Phase III Trials.

Authors:  Benjamin Farahnik; Kourosh Beroukhim; Michael Abrouk; Mio Nakamura; Tian Hao Zhu; Rasnik Singh; Kristina Lee; Tina Bhutani; John Koo
Journal:  Dermatol Ther (Heidelb)       Date:  2016-05-25
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  9 in total

Review 1.  Targeting IL-17 in psoriatic arthritis.

Authors:  Elizabeth A Wang; Erika Suzuki; Emanual Maverakis; Iannis E Adamopoulos
Journal:  Eur J Rheumatol       Date:  2017-11-10

2.  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

3.  Small-Molecule Inhibitors of Haemophilus influenzae IgA1 Protease.

Authors:  Livia Shehaj; Santosh K Choudary; Kamlesh M Makwana; Mary C Gallo; Timothy F Murphy; Joshua A Kritzer
Journal:  ACS Infect Dis       Date:  2019-05-03       Impact factor: 5.084

Review 4.  Targeted Treatment for Erythrodermic Psoriasis: Rationale and Recent Advances.

Authors:  Shuai Shao; Gang Wang; Emanual Maverakis; Johann E Gudjonsson
Journal:  Drugs       Date:  2020-04       Impact factor: 9.546

5.  Role of Interstitial Fluid Turnover on Target Suppression by Therapeutic Biologics Using a Minimal Physiologically Based Pharmacokinetic Model.

Authors:  Xiaobing Li; William J Jusko; Yanguang Cao
Journal:  J Pharmacol Exp Ther       Date:  2018-07-12       Impact factor: 4.030

Review 6.  Mucocutaneous IL-17 immunity in mice and humans: host defense vs. excessive inflammation.

Authors:  J Li; J-L Casanova; A Puel
Journal:  Mucosal Immunol       Date:  2017-11-29       Impact factor: 7.313

7.  Tofacitinib for the treatment of moderate to severe chronic plaque psoriasis in Japanese patients: Subgroup analyses from a randomized, placebo-controlled phase 3 trial.

Authors:  Masatoshi Abe; Chikako Nishigori; Hideshi Torii; Hironobu Ihn; Kei Ito; Makoto Nagaoka; Naoki Isogawa; Isao Kawaguchi; Yukiko Tomochika; Mihoko Kobayashi; Anna M Tallman; Kim A Papp
Journal:  J Dermatol       Date:  2017-07-17       Impact factor: 4.005

Review 8.  Spotlight on brodalumab in the treatment of moderate-to-severe plaque psoriasis: design, development, and potential place in therapy.

Authors:  Michael Roman; Melvin W Chiu
Journal:  Drug Des Devel Ther       Date:  2017-07-07       Impact factor: 4.162

9.  Long-term safety of brodalumab in Japanese patients with plaque psoriasis: An open-label extension study.

Authors:  Yukie Yamaguchi; Nobumichi Takatsu; Kenji Ootaki; Hidemi Nakagawa
Journal:  J Dermatol       Date:  2020-04-10       Impact factor: 4.005
  9 in total

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