Apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated effectiveness (versus placebo) for treatment of active psoriatic\narthritis in the psoriatic arthritis long-term assessment of clinical efficacy (PALACE) phase III clinical trial program.\nPharmacodynamic effects of apremilast on plasma biomarkers associated with inflammation were evaluated in a PALACE 1\nsubstudy. Of 504 patients randomized in PALACE 1, 150 (placebo: ???? = 51; apremilast 20mg BID: ???? = 51; apremilast 30mg\nBID: ???? = 48) provided peripheral blood plasma samples for analysis in a multiplexed cytometric bead array assay measuring\n47 proteins associated with systemic inflammatory immune responses. Association between biomarker levels and achievement of\n20% improvement from baseline in modified American College of Rheumatology (ACR20) response criteria was assessed by logistic\nregression. At Week 24, IL-8, TNF-n, IL-6, MIP-1n, MCP-1, and ferritin were significantly reduced from baseline with apremilast\n20mg BID or 30mg BID versus placebo. ACR20 response correlated with change in TNF-n level with both apremilast doses. At\nWeek 40, IL-17, IL-23, IL-6, and ferritin were significantly decreased and IL-10 and IL-1 receptor antagonists significantly increased\nwith apremilast 30mg BID versus placebo. In patients with active psoriatic arthritis, apremilast reduced circulating levels of Th1\nand Th17 proinflammatory mediators and increased anti-inflammatory mediators.
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