{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T16:47:39Z","timestamp":1786639659148,"version":"build-2736575974"},"reference-count":23,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,10,23]],"date-time":"2023-10-23T00:00:00Z","timestamp":1698019200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2023,12]]},"abstract":"Abstract<\/jats:title>Oral corticosteroid use is limited by side effects, some caused by off\u2010target actions on the mineralocorticoid receptor that disrupt electrolyte balance. AZD9567 is a selective, nonsteroidal glucocorticoid receptor modulator. The efficacy, safety, and tolerability of AZD9567 and prednisolone were assessed in a phase IIa study. Anti\u2010inflammatory mechanism of action was also evaluated in vitro in monocytes from healthy donors. In this randomized, double\u2010blind, parallel\u2010group, multicenter study, patients with active rheumatoid arthritis were randomized 1:1 to AZD9567 40\u2009mg or prednisolone 20\u2009mg once daily orally for 14\u2009days. The primary end point was change from baseline in DAS28\u2010CRP at day 15. Secondary end points included components of DAS28\u2010CRP, American College of Rheumatology (ACR) response criteria (ACR20, ACR50, and ACR70), and safety end points, including serum electrolytes. Overall, 21 patients were randomized to AZD9567 (n<\/jats:italic>\u2009=\u200911) or prednisolone (n<\/jats:italic>\u2009=\u200910), and all completed the study. As anticipated, AZD9567 had a similar efficacy profile to prednisolone, with no clinically meaningful (i.e., >1.0) difference in change from baseline to day 15 in DAS28\u2010CRP between AZD9567 and prednisolone (least\u2010squares mean difference: 0.47, 95% confidence interval: \u22120.49 to 1.43). Similar results were observed for the secondary efficacy end points. In vitro transcriptomic analysis showed that anti\u2010inflammatory responses were similar for AZD9567, prednisolone, and dexamethasone. Unlike prednisolone, AZD9567 had no effect on the serum sodium:potassium ratio. The safety profile was not different from that of prednisolone. Larger studies of longer duration are required to determine whether AZD9567 40\u2009mg may in the future be an alternative to prednisolone in patients with inflammatory disease.<\/jats:p>","DOI":"10.1111\/cts.13624","type":"journal-article","created":{"date-parts":[[2023,10,24]],"date-time":"2023-10-24T06:23:45Z","timestamp":1698128625000},"page":"2494-2506","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["AZD9567<\/scp> versus prednisolone in patients with active rheumatoid arthritis: A phase IIa<\/scp>, randomized, double\u2010blind, efficacy, and safety study"],"prefix":"10.1111","volume":"16","author":[{"given":"Jacob M.","family":"van Laar","sequence":"first","affiliation":[{"name":"Division of Internal Medicine and Dermatology, Department of Rheumatology & Clinical Immunology University Medical Center Utrecht Utrecht The 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