{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T17:42:54Z","timestamp":1790358174622,"version":"4.1.0"},"reference-count":17,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2017,3,31]],"date-time":"2017-03-31T00:00:00Z","timestamp":1490918400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2017,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Interferon\u2010\u03b3 (IFN\u03b3) is implicated in the pathogenesis of discoid lupus erythematosus (DLE). This study sought to evaluate a single dose of AMG 811, an anti\u2010IFN\u03b3 antibody, in patients with DLE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study was designed as a phase I randomized, double\u2010blind, placebo\u2010controlled crossover study of the pharmacodynamics, safety, and clinical efficacy of AMG 811 in patients with DLE. Patients received a single subcutaneous dose of AMG 811 (180 mg) or placebo. The patients in sequence 1 received AMG 811 followed by placebo, while those in sequence 2 received placebo followed by AMG 811. Pharmacodynamic end points included global transcriptional analyses of lesional and nonlesional skin, IFN\u03b3 blockade signature (IGBS) transcriptional scores in the skin and blood, keratinocyte IFN\u03b3 RNA scores, and serum levels of CXCL10 protein. Additional end points were efficacy outcome measures, including the Cutaneous Lupus Erythematosus Disease Area and Severity Index, and safety outcome measures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Sixteen patients with DLE were enrolled in the study (9 in sequence 1 and 7 in sequence 2). AMG 811 treatment reduced the IGBS score (which was elevated in DLE patients at baseline) in both the blood and lesional skin. The keratinocyte IFN\u03b3 RNA score was not affected by administration of AMG 811. Serum CXCL10 protein levels (which were elevated in the blood of DLE patients) were reduced with AMG 811 treatment. The AMG 811 treatment was well tolerated but did not lead to statistically significant improvements in any of the efficacy outcome measures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>AMG 811 treatment led to changes in IFN\u03b3\u2010associated biomarkers and was well tolerated, but no significant clinical benefit was observed in patients with DLE.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.40052","type":"journal-article","created":{"date-parts":[[2017,1,24]],"date-time":"2017-01-24T14:06:43Z","timestamp":1485266803000},"page":"1028-1034","source":"Crossref","is-referenced-by-count":75,"title":["Brief Report: Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti\u2013Interferon\u2010\u03b3 Antibody, in Patients With Discoid Lupus Erythematosus"],"prefix":"10.1002","volume":"69","author":[{"given":"Victoria P.","family":"Werth","sequence":"first","affiliation":[{"name":"University of Pennsylvania and Corporal Michael J. Crescenz Veterans Administration Medical Center Philadelphia Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Fiorentino","sequence":"additional","affiliation":[{"name":"Stanford University Palo Alto California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara A.","family":"Sullivan","sequence":"additional","affiliation":[{"name":"Amgen Inc. Thousand Oaks California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Boedigheimer","sequence":"additional","affiliation":[{"name":"Amgen Inc. Thousand Oaks California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kit","family":"Chiu","sequence":"additional","affiliation":[{"name":"Amgen Inc. Thousand Oaks California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Wang","sequence":"additional","affiliation":[{"name":"Amgen Inc. 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Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Martin","sequence":"additional","affiliation":[{"name":"Amgen, Inc. Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James B.","family":"Chung","sequence":"additional","affiliation":[{"name":"Amgen Inc. 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