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The Pharmacodynamic Impact of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, on Circulating Levels of Inflammatory Biomarkers in Patients with Psoriatic Arthritis: Substudy Results from a Phase III, Randomized, Placebo-Controlled Trial (PALACE 1)
Joint Authors
Schafer, Peter H.
Chen, Peng
Fang, Lorraine
Wang, Andrew
Chopra, Rajesh
Source
Journal of Immunology Research
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-04-20
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
Apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated effectiveness (versus placebo) for treatment of active psoriatic arthritis in the psoriatic arthritis long-term assessment of clinical efficacy (PALACE) phase III clinical trial program.
Pharmacodynamic effects of apremilast on plasma biomarkers associated with inflammation were evaluated in a PALACE 1 substudy.
Of 504 patients randomized in PALACE 1, 150 (placebo: n = 51 ; apremilast 20 mg BID: n = 51 ; apremilast 30 mg BID: n = 48 ) provided peripheral blood plasma samples for analysis in a multiplexed cytometric bead array assay measuring 47 proteins associated with systemic inflammatory immune responses.
Association between biomarker levels and achievement of 20% improvement from baseline in modified American College of Rheumatology (ACR20) response criteria was assessed by logistic regression.
At Week 24, IL-8, TNF-α, IL-6, MIP-1β, MCP-1, and ferritin were significantly reduced from baseline with apremilast 20 mg BID or 30 mg BID versus placebo.
ACR20 response correlated with change in TNF-α level with both apremilast doses.
At Week 40, IL-17, IL-23, IL-6, and ferritin were significantly decreased and IL-10 and IL-1 receptor antagonists significantly increased with apremilast 30 mg BID versus placebo.
In patients with active psoriatic arthritis, apremilast reduced circulating levels of Th1 and Th17 proinflammatory mediators and increased anti-inflammatory mediators.
American Psychological Association (APA)
Schafer, Peter H.& Chen, Peng& Fang, Lorraine& Wang, Andrew& Chopra, Rajesh. 2015. The Pharmacodynamic Impact of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, on Circulating Levels of Inflammatory Biomarkers in Patients with Psoriatic Arthritis: Substudy Results from a Phase III, Randomized, Placebo-Controlled Trial (PALACE 1). Journal of Immunology Research،Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1068636
Modern Language Association (MLA)
Schafer, Peter H.…[et al.]. The Pharmacodynamic Impact of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, on Circulating Levels of Inflammatory Biomarkers in Patients with Psoriatic Arthritis: Substudy Results from a Phase III, Randomized, Placebo-Controlled Trial (PALACE 1). Journal of Immunology Research No. 2015 (2015), pp.1-10.
https://search.emarefa.net/detail/BIM-1068636
American Medical Association (AMA)
Schafer, Peter H.& Chen, Peng& Fang, Lorraine& Wang, Andrew& Chopra, Rajesh. The Pharmacodynamic Impact of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, on Circulating Levels of Inflammatory Biomarkers in Patients with Psoriatic Arthritis: Substudy Results from a Phase III, Randomized, Placebo-Controlled Trial (PALACE 1). Journal of Immunology Research. 2015. Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1068636
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1068636