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Apremilast: A Review in Psoriasis and Psoriatic Arthritis

Abstract

Apremilast (Otezla®) is an orally administered, small molecule inhibitor of phosphodiesterase 4 (PDE4). Apremilast 30 mg twice daily reduced the severity of moderate to severe plaque psoriasis in the phase 3 ESTEEM trials, as well as improving difficult-to-treat nail, scalp and palmoplantar psoriasis. Most patient-reported outcomes, including pruritus and the total Dermatology Life Quality Index, also improved to a significantly greater extent with apremilast than with placebo, with significant improvements in pruritus and skin discomfort/pain visual analogue scale scores seen as early as week 2 with apremilast. Apremilast 30 mg twice daily improved signs and symptoms in both disease-modifying antirheumatic drug (DMARD)-naïve and DMARD-experienced patients with active psoriatic arthritis in the phase 3 PALACE trials. Enthesitis, dactylitis, physical function and fatigue were also improved with apremilast, and its efficacy was sustained for up to 208 weeks. Apremilast had an early onset of efficacy in patients with active psoriatic arthritis, with significantly more apremilast 30 mg twice daily than placebo recipients achieving a ≥20% improvement in modified American College of Rheumatology response criteria at week 2 in the phase 3b ACTIVE trial. Apremilast was generally well tolerated in patients with psoriasis and psoriatic arthritis; no laboratory monitoring is required. In conclusion, orally administered apremilast is an effective, generally well tolerated and convenient option for the treatment of psoriasis and psoriatic arthritis.

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Acknowledgements

During the peer review process, the manufacturer of apremilast was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Gillian M. Keating.

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The preparation of this review was not supported by any external funding.

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Gillian Keating is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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The manuscript was reviewed by: J.C. Cather, Modern Research Associates and Modern Dermatology, A Baylor Health Texas Affiliate, Dallas, TX, USA; L.R. Espinoza, Section of Rheumatology, LSU Health Sciences Center at New Orleans, New Orleans, LA, USA; M. Ohtsuki; Department of Dermatology, Jichi Medical University, Shimotsuke, Japan.

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Keating, G.M. Apremilast: A Review in Psoriasis and Psoriatic Arthritis. Drugs 77, 459–472 (2017). https://doi.org/10.1007/s40265-017-0709-1

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Keywords

  • Psoriasis
  • Psoriatic Arthritis
  • Bath Ankylose Spondylitis Disease Activity Index
  • Ustekinumab
  • Cystic Fibrosis Transmembrane Regulator