Drug intelligence / Profile preview

placebo + apremilast

Development stage
Unknown
Lead developer
Amgen
Modality
Small Molecules
Administration
Oral
01

Overview

Placebo + apremilast refers to the comparative treatment arms utilized in the PALACE 2 Phase 3 clinical trial (NCT01212757), which evaluated the efficacy and safety of apremilast in patients with active psoriatic arthritis. Apremilast, marketed under the brand name Otezla, is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4). By inhibiting PDE4, apremilast increases intracellular levels of cyclic adenosine monophosphate (cAMP), which in turn modulates the expression of numerous pro-inflammatory and anti-inflammatory mediators, including TNF-alpha, IL-23, and IL-10. The PALACE 2 study specifically investigated the drug in patients who had an inadequate response to conventional disease-modifying antirheumatic drugs (DMARDs). Originally developed by Celgene and now part of the Amgen portfolio, apremilast is FDA-approved for psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behçet's Disease.

02

Targets

PDE4 (Phosphodiesterase 4A1)

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