Literature DB >> 28547386

Dupilumab: First Global Approval.

Matt Shirley1.   

Abstract

Dupilumab (Dupixent®) is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α (IL-4Rα) subunit. Dupilumab inhibits the signalling of the type 2 cytokines IL-4 and IL-13 and was co-developed by Regeneron Pharmaceuticals and Sanofi as a potential therapeutic agent for the treatment of atopic or allergic diseases. In March 2017 dupilumab received its first global approval, in the USA, for use in the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab is in preregistration for this indication in the EU. In addition, dupilumab is currently under phase III development across the world for the treatment of asthma and nasal polyposis as well as for atopic dermatitis in paediatric patients. The agent has also entered phase II development in the USA for the treatment of eosinophilic oesophagitis. This article summarizes the milestones in the development of dupilumab leading to this first approval for the treatment of moderate-to-severe atopic dermatitis in adults.

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Year:  2017        PMID： 28547386     DOI： 10.1007/s40265-017-0768-3

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


  9 in total

1.  Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial.

Authors:  Andrew Blauvelt; Marjolein de Bruin-Weller; Melinda Gooderham; Jennifer C Cather; Jamie Weisman; David Pariser; Eric L Simpson; Kim A Papp; H Chih-Ho Hong; Diana Rubel; Peter Foley; Errol Prens; Christopher E M Griffiths; Takafumi Etoh; Pedro Herranz Pinto; Ramon M Pujol; Jacek C Szepietowski; Karel Ettler; Lajos Kemény; Xiaoping Zhu; Bolanle Akinlade; Thomas Hultsch; Vera Mastey; Abhijit Gadkari; Laurent Eckert; Nikhil Amin; Neil M H Graham; Gianluca Pirozzi; Neil Stahl; George D Yancopoulos; Brad Shumel
Journal:  Lancet       Date:  2017-05-04       Impact factor: 79.321

2.  Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis.

Authors:  Eric L Simpson; Thomas Bieber; Emma Guttman-Yassky; Lisa A Beck; Andrew Blauvelt; Michael J Cork; Jonathan I Silverberg; Mette Deleuran; Yoko Kataoka; Jean-Philippe Lacour; Külli Kingo; Margitta Worm; Yves Poulin; Andreas Wollenberg; Yuhwen Soo; Neil M H Graham; Gianluca Pirozzi; Bolanle Akinlade; Heribert Staudinger; Vera Mastey; Laurent Eckert; Abhijit Gadkari; Neil Stahl; George D Yancopoulos; Marius Ardeleanu
Journal:  N Engl J Med       Date:  2016-09-30       Impact factor: 91.245

3.  Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial.

Authors:  Sally Wenzel; Mario Castro; Jonathan Corren; Jorge Maspero; Lin Wang; Bingzhi Zhang; Gianluca Pirozzi; E Rand Sutherland; Robert R Evans; Vijay N Joish; Laurent Eckert; Neil M H Graham; Neil Stahl; George D Yancopoulos; Mariana Louis-Tisserand; Ariel Teper
Journal:  Lancet       Date:  2016-04-27       Impact factor: 79.321

4.  Dupilumab in persistent asthma with elevated eosinophil levels.

Authors:  Sally Wenzel; Linda Ford; David Pearlman; Sheldon Spector; Lawrence Sher; Franck Skobieranda; Lin Wang; Stephane Kirkesseli; Ross Rocklin; Brian Bock; Jennifer Hamilton; Jeffrey E Ming; Allen Radin; Neil Stahl; George D Yancopoulos; Neil Graham; Gianluca Pirozzi
Journal:  N Engl J Med       Date:  2013-05-21       Impact factor: 91.245

5.  Dupilumab treatment in adults with moderate-to-severe atopic dermatitis.

Authors:  Lisa A Beck; Diamant Thaçi; Jennifer D Hamilton; Neil M Graham; Thomas Bieber; Ross Rocklin; Jeffrey E Ming; Haobo Ren; Richard Kao; Eric Simpson; Marius Ardeleanu; Steven P Weinstein; Gianluca Pirozzi; Emma Guttman-Yassky; Mayte Suárez-Fariñas; Melissa D Hager; Neil Stahl; George D Yancopoulos; Allen R Radin
Journal:  N Engl J Med       Date:  2014-07-10       Impact factor: 91.245

6.  Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD).

Authors:  Eric L Simpson; Abhijit Gadkari; Margitta Worm; Weily Soong; Andrew Blauvelt; Laurent Eckert; Richard Wu; Marius Ardeleanu; Neil M H Graham; Gianluca Pirozzi; E Rand Sutherland; Vera Mastey
Journal:  J Am Acad Dermatol       Date:  2016-06-04       Impact factor: 11.527

7.  Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial.

Authors:  Diamant Thaçi; Eric L Simpson; Lisa A Beck; Thomas Bieber; Andrew Blauvelt; Kim Papp; Weily Soong; Margitta Worm; Jacek C Szepietowski; Howard Sofen; Makoto Kawashima; Richard Wu; Steven P Weinstein; Neil M H Graham; Gianluca Pirozzi; Ariel Teper; E Rand Sutherland; Vera Mastey; Neil Stahl; George D Yancopoulos; Marius Ardeleanu
Journal:  Lancet       Date:  2015-10-08       Impact factor: 79.321

8.  Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial.

Authors:  Claus Bachert; Leda Mannent; Robert M Naclerio; Joaquim Mullol; Berrylin J Ferguson; Philippe Gevaert; Peter Hellings; Lixia Jiao; Lin Wang; Robert R Evans; Gianluca Pirozzi; Neil M Graham; Brian Swanson; Jennifer D Hamilton; Allen Radin; Namita A Gandhi; Neil Stahl; George D Yancopoulos; E Rand Sutherland
Journal:  JAMA       Date:  2016-02-02       Impact factor: 56.272

9.  Exploratory Population PK Analysis of Dupilumab, a Fully Human Monoclonal Antibody Against IL-4Rα, in Atopic Dermatitis Patients and Normal Volunteers.

Authors:  P Kovalenko; A T DiCioccio; J D Davis; M Li; M Ardeleanu; Nmh Graham; R Soltys
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2016-10-25
  9 in total
  27 in total

1.  Impact of COVID-19 on patients with atopic dermatitis.

Authors:  Teresa Grieco; Camilla Chello; Alvise Sernicola; Rovena Muharremi; Simone Michelini; Giovanni Paolino; Giorgia Carnicelli; Paolo Daniele Pigatto
Journal:  Clin Dermatol       Date:  2021-07-17       Impact factor: 3.541

2.  Dupilumab (Dupixent®) tends to be an effective therapy for uncontrolled severe chronic rhinosinusitis with nasal polyps: real data of a single-centered, retrospective single-arm longitudinal study from a university hospital in Germany.

Authors:  Florian Jansen; Benjamin Becker; Jördis K Eden; Philippe C Breda; Amra Hot; Tim Oqueka; Christian S Betz; Anna S Hoffmann
Journal:  Eur Arch Otorhinolaryngol       Date:  2022-10-15       Impact factor: 3.236

Review 3.  Biological Therapy of Severe Asthma with Dupilumab, a Dual Receptor Antagonist of Interleukins 4 and 13.

Authors:  Corrado Pelaia; Giulia Pelaia; Claudia Crimi; Angelantonio Maglio; Giuseppe Armentaro; Cecilia Calabrese; Angela Sciacqua; Luca Gallelli; Alessandro Vatrella
Journal:  Vaccines (Basel)       Date:  2022-06-19

Review 4.  The IL-4/IL-13 axis in skin fibrosis and scarring: mechanistic concepts and therapeutic targets.

Authors:  Julie K Nguyen; Evan Austin; Alisen Huang; Andrew Mamalis; Jared Jagdeo
Journal:  Arch Dermatol Res       Date:  2019-09-06       Impact factor: 3.017

Review 5.  New treatment directions in food allergy.

Authors:  Vanitha Sampath; Sayantani B Sindher; Wenming Zhang; Kari C Nadeau
Journal:  Ann Allergy Asthma Immunol       Date:  2018-03       Impact factor: 6.347

6.  NF-κB perturbation reveals unique immunomodulatory functions in Prx1+ fibroblasts that promote development of atopic dermatitis.

Authors:  Kang I Ko; Jean J Merlet; Brett P DerGarabedian; Huang Zhen; Yoko Suzuki-Horiuchi; Matthew L Hedberg; Eileen Hu; Anh T Nguyen; Stephen Prouty; Faizan Alawi; Matthew C Walsh; Yongwon Choi; Sarah E Millar; Ashley Cliff; Jonathon Romero; Michael R Garvin; John T Seykora; Daniel Jacobson; Dana T Graves
Journal:  Sci Transl Med       Date:  2022-02-02       Impact factor: 19.319

7.  Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults.

Authors:  Xinghua Xu; Yi Zheng; Xin Zhang; Yanling He; Chengxin Li
Journal:  Oncotarget       Date:  2017-11-18

8.  Assessing the Heterogeneity of the Fc-Glycan of a Therapeutic Antibody Using an engineered FcγReceptor IIIa-Immobilized Column.

Authors:  Masato Kiyoshi; Jose M M Caaveiro; Minoru Tada; Hiroko Tamura; Toru Tanaka; Yosuke Terao; Koldo Morante; Akira Harazono; Noritaka Hashii; Hiroko Shibata; Daisuke Kuroda; Satoru Nagatoishi; Seigo Oe; Teruhiko Ide; Kouhei Tsumoto; Akiko Ishii-Watabe
Journal:  Sci Rep       Date:  2018-03-02       Impact factor: 4.379

9.  Ocular surface disorders associated with the use of dupilumab based on WHO VigiBase.

Authors:  Sunny Park; Jung Hyun Lee; Ji Hyun Park; So Hyang Park; Song Yi Park; Yong Woo Jung; Soo An Choi
Journal:  Sci Rep       Date:  2021-07-12       Impact factor: 4.379

10.  Alopecia areata after dupilumab for atopic dermatitis.

Authors:  Krystal Mitchell; Jacob Levitt
Journal:  JAAD Case Rep       Date:  2018-01-16
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