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Apremilast mechanism of efficacy in systemic-naive patients with moderate plaque psoriasis: Pharmacodynamic results from the UNVEIL study. | LitMetric

AI Article Synopsis

  • A phase IV trial (UNVEIL) studied the effects of apremilast on moderate plaque psoriasis patients, focusing on how treatment influences inflammatory biomarkers and overall efficacy.* ! -
  • The trial involved 221 patients, comparing apremilast (30 mg twice daily) with a placebo over 16 weeks, measuring levels of specific interleukins (like IL-17A) and T-cell counts.* ! -
  • Results showed significant reductions in IL-17A and other inflammatory markers with apremilast, linking clinical improvement in psoriasis to these decreases, while other biomarkers remained mostly unchanged.* !

Article Abstract

Background: Pharmacodynamic (PD) subanalyses of clinical trials in patients with moderate to severe psoriasis demonstrated the efficacy of apremilast correlated with reductions in cytokines involved in the pathogenesis of psoriasis.

Objective: This PD subanalysis of a phase IV, randomized, controlled trial (UNVEIL) in systemic-naive patients with moderate plaque psoriasis (psoriasis-involved body surface area [BSA] 5%-10%; static Physician's Global Assessment [sPGA] = 3) evaluated the relationship between efficacy and changes in inflammatory biomarkers with apremilast 30 mg twice daily (BID) versus placebo.

Methods: Patients were randomized (2:1) to apremilast 30 mg BID or placebo for 16 weeks. Blood samples were analyzed for interleukins (IL)-17A, -17F, -22, and -23; cardiometabolic biomarkers (leptin; adiponectin; apolipoproteins A-I, A-II, B, and E); and the number of T-helper 17 (Th17) cells, regulatory T cells, and total T cells at Weeks 0, 4, and 16. Correlations were examined between percentage change in biomarkers and efficacy (based on PGAxBSA).

Results: Of 221 randomized patients, 38 were included in PD analyses (placebo, n = 12; apremilast, n = 26). Median percentage reductions in plasma cytokine levels were significantly greater with apremilast versus placebo for IL-17A (P < 0.05), IL -17F (P < 0.001), and IL-22 (P < 0.01) at Week 4 and IL-22 (P < 0.05) at Week 16. At Week 16, in patients receiving apremilast, improvement in PGAxBSA significantly correlated with change in IL-17A (r = 0.45, P = 0.04). Adipokines, apolipoproteins, and T-cell population levels were largely unchanged.

Conclusion: Clinical improvements in psoriasis correlated with apremilast-mediated decreases in IL-17A without significantly affecting systemic IL-23 levels, adipokines, or Th17 and regulatory T-cell numbers.

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Source
http://dx.doi.org/10.1016/j.jdermsci.2019.09.003DOI Listing

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