Psoriasis treatment with traditional systemic or biologic therapies may be compromised by safety and tolerability concerns, administration (injection versus oral), and lack/loss of response.1-5 Efficacious, safe, well-tolerated, and easy-to-use treatment options remain a goal for psoriasis patients.
Cyclic adenosine monophosphate (cAMP) is a naturally
occurring intracellular secondary messenger that functions as a modulator of inflammatory responses.6,7 Phosphodiesterase 4
(PDE4) is the predominant PDE in inflammatory cells and present in keratinocytes.8 Apremilast (Celgene Corporation, Summit,
NJ), a small molecule specific inhibitor of PDE4, works intracellularly to elevate cAMP levels, modulating a network of
inflammatory mediators implicated in psoriasis and psoriatic arthritis (PsA).9-11 In preclinical studies, apremilast reduced
production of pro-inflammatory mediators, such as tumor necrosis factor (TNF)-α, IL-23, and interferon-γ, and increased
production of anti-inflammatory mediators, such as IL-10.8 Apremilast has shown efficacy in moderate to severe
plaque psoriasis and active PsA12-14 and is in phase III studies for psoriasis, PsA, and ankylosing spondylitis. This phase
II, open-label study assessed the efficacy, tolerability, and pharmacodynamics of apremilast in recalcitrant plaque psoriasis.
This phase II, multicenter, open-label study evaluated the efficacy, tolerability, safety, and pharmacodynamics of apremilast
in patients with recalcitrant plaque psoriasis from August 2007 to May 2009 at four US centers. The study comprised four
phases: pre-treatment (≤35 days), treatment (12 weeks), extension (12 weeks), and observational follow-up (4 weeks). Patients
received oral apremilast 20 mg BID for 12 weeks. A one-time apremilast dose reduction to 20 mg QD was allowed for patients
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