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Literature DB >> 24797159

Apremilast: first global approval.

Raewyn M Poole¹, Anita D Ballantyne.
1. Adis, Auckland, New Zealand.

Abstract

Apremilast (Otezla(®)), an oral small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4), is under development with Celgene Corporation for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, Behçet's syndrome, atopic dermatitis, and rheumatoid arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis in adults. Apremilast has received its first global approval for this indication in the USA. Regulatory submissions for approval in this indication are under review in Canada and Europe. Regulatory filings have also been submitted for apremilast in the treatment of plaque psoriasis in the USA and Europe. This article summarizes the milestones in the development of apremilast leading to its first approval for the treatment of psoriatic arthritis.

Entities: Chemical Disease Gene

Mesh：

Substances：

Year: 2014 PMID： 24797159 DOI： 10.1007/s40265-014-0218-4

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

24 in total

1. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial.

Authors: Kim Papp; Jennifer C Cather; Les Rosoph; Howard Sofen; Richard G Langley; Robert T Matheson; ChiaChi Hu; Robert M Day
Journal: Lancet Date: 2012-06-29 Impact factor: 79.321

2. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis.

Authors: Peter Schafer
Journal: Biochem Pharmacol Date: 2012-01-10 Impact factor: 5.858

3. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents.

Authors: Alan Menter; Neil J Korman; Craig A Elmets; Steven R Feldman; Joel M Gelfand; Kenneth B Gordon; Alice B Gottlieb; John Y M Koo; Mark Lebwohl; Henry W Lim; Abby S Van Voorhees; Karl R Beutner; Reva Bhushan
Journal: J Am Acad Dermatol Date: 2009-06-03 Impact factor: 11.527

4. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast.

Authors: A B Gottlieb; B Strober; J G Krueger; P Rohane; J B Zeldis; C C Hu; C Kipnis
Journal: Curr Med Res Opin Date: 2008-04-16 Impact factor: 2.580

5. Apremilast in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Pilot Study.

Authors: Gregory P McLENNAN; Iyad Khourdaji; Kim A Killinger; Judith A Boura; Kenneth M Peters
Journal: Low Urin Tract Symptoms Date: 2012-03-29 Impact factor: 1.592

6. Apremilast for discoid lupus erythematosus: results of a phase 2, open-label, single-arm, pilot study.

Authors: Aieska De Souza; Bruce E Strober; Joseph F Merola; Stephen Oliver; Andrew G Franks
Journal: J Drugs Dermatol Date: 2012-10 Impact factor: 2.114

7. Apremilast, a novel PDE4 inhibitor, inhibits spontaneous production of tumour necrosis factor-alpha from human rheumatoid synovial cells and ameliorates experimental arthritis.

Authors: Fiona E McCann; Andrew C Palfreeman; Melanie Andrews; Dany P Perocheau; Julia J Inglis; Peter Schafer; Marc Feldmann; Richard O Williams; Fionula M Brennan
Journal: Arthritis Res Ther Date: 2010-06-02 Impact factor: 5.156

Review 8. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis.

Authors: Philip J Mease; April W Armstrong
Journal: Drugs Date: 2014-03 Impact factor: 9.546

Review 9. Phosphodiesterase 4-targeted treatments for autoimmune diseases.

Authors: Neal Kumar; Ari M Goldminz; Noori Kim; Alice B Gottlieb
Journal: BMC Med Date: 2013-04-04 Impact factor: 8.775

10. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor.

Authors: Arthur Kavanaugh; Philip J Mease; Juan J Gomez-Reino; Adewale O Adebajo; Jürgen Wollenhaupt; Dafna D Gladman; Eric Lespessailles; Stephen Hall; Marla Hochfeld; ChiaChi Hu; Douglas Hough; Randall M Stevens; Georg Schett
Journal: Ann Rheum Dis Date: 2014-03-04 Impact factor: 19.103

17 in total

1. Roflumilast ameliorates cognitive impairment in APP/PS1 mice via cAMP/CREB/BDNF signaling and anti-neuroinflammatory effects.

Authors: Huancun Feng; Canmao Wang; Wei He; Xinjun Wu; Shujie Li; Zhenkun Zeng; Meidan Wei; Binghong He
Journal: Metab Brain Dis Date: 2019-01-04 Impact factor: 3.584

2. Identification of a PDE4-Specific Pocket for the Design of Selective Inhibitors.

Authors: Xiaoqing Feng; Huanchen Wang; Mengchun Ye; Xue-Tao Xu; Ying Xu; Wenzhe Yang; Han-Ting Zhang; Guoqiang Song; Hengming Ke
Journal: Biochemistry Date: 2018-07-17 Impact factor: 3.162

Review 3. Alopecia Areata: an Update on Etiopathogenesis, Diagnosis, and Management.

Authors: Cheng Zhou; Xiangqian Li; Chen Wang; Jianzhong Zhang
Journal: Clin Rev Allergy Immunol Date: 2021-08-17 Impact factor: 8.667

Review 4. Alopecia areata: Animal models illuminate autoimmune pathogenesis and novel immunotherapeutic strategies.

Authors: Amos Gilhar; Adam G Schrum; Amos Etzioni; Herman Waldmann; Ralf Paus
Journal: Autoimmun Rev Date: 2016-03-10 Impact factor: 9.754

Review 5. The sympathetic nervous response in inflammation.

Authors: Georg Pongratz; Rainer H Straub
Journal: Arthritis Res Ther Date: 2014 Impact factor: 5.156

6. Differential Expression and Function of PDE8 and PDE4 in Effector T cells: Implications for PDE8 as a Drug Target in Inflammation.

Authors: Amanda G Vang; Chaitali Basole; Hongli Dong; Rebecca K Nguyen; William Housley; Linda Guernsey; Alexander J Adami; Roger S Thrall; Robert B Clark; Paul M Epstein; Stefan Brocke
Journal: Front Pharmacol Date: 2016-08-23 Impact factor: 5.810

7. Consensus Guidelines for the Treatment of Atopic Dermatitis in Korea (Part I): General Management and Topical Treatment.

Authors: Jung Eun Kim; Hyun Jeong Kim; Bark-Lynn Lew; Kyung Ho Lee; Seung Phil Hong; Yong Hyun Jang; Kui Young Park; Seong Jun Seo; Jung Min Bae; Eung Ho Choi; Ki Beom Suhr; Seung Chul Lee; Hyun Chang Ko; Young Lip Park; Sang Wook Son; Young Jun Seo; Yang Won Lee; Sang Hyun Cho; Chun Wook Park; Joo Young Roh
Journal: Ann Dermatol Date: 2015-10-02 Impact factor: 1.444