{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:54:58Z","timestamp":1792788898434,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,4,2]],"date-time":"2025-04-02T00:00:00Z","timestamp":1743552000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acrjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Arthritis &amp; Rheumatology"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>An unmet need exists for glucocorticoid\u2010sparing treatments for patients with polymyalgia rheumatica (PMR). The antibody\u2010drug conjugate ABBV\u2010154 comprises adalimumab conjugated to a glucocorticoid receptor modulator. We evaluated ABBV\u2010154 versus placebo in patients with glucocorticoid\u2010dependent PMR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this phase 2, randomized, double\u2010blind, placebo\u2010controlled, dose\u2010ranging study, eligible patients had confirmed PMR, glucocorticoid response and two or more unequivocal PMR flares while tapering glucocorticoids and still on \u22655 mg daily prednisone equivalent. Randomized patients received subcutaneous placebo or ABBV\u2010154 40, 150, or 340 mg once every other week. The primary efficacy endpoint was time to flare. The sponsor voluntarily terminated the study early.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Overall, 181 patients were randomized (placebo, n = 50; ABBV\u2010154: 40 mg, n = 42; 150 mg, n = 45; 340 mg, n = 44), and 67.4% completed study drug at week 24. Time to flare was longer for patients receiving ABBV\u2010154 than those receiving placebo, with Kaplan\u2010Meier estimate of 24\u2010week flare\u2010free rate being lower for placebo. The hazard ratios of ABBV\u2010154 versus placebo were 0.49 (95% confidence interval [CI], 0.27\u20130.88),\n                      <jats:italic>P<\/jats:italic>\n                      = 0.017 for 40 mg; 0.44 (95% CI, 0.25\u20130.79),\n                      <jats:italic>P<\/jats:italic>\n                      = 0.006 for 150 mg; 0.20 (95% CI, 0.09\u20130.42),\n                      <jats:italic>P<\/jats:italic>\n                      &lt; 0.001 for 340 mg. Incidences of treatment\u2010emergent adverse events were similar between groups, and the most common across ABBV\u2010154 cohorts was COVID\u201019 (16.0%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Treatment effects were observed for ABBV\u2010154 cohorts compared with placebo for time to flare. ABBV\u2010154 was generally well tolerated. Due to early study termination, results should be interpreted with caution.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/art.43129","type":"journal-article","created":{"date-parts":[[2025,1,27]],"date-time":"2025-01-27T03:53:59Z","timestamp":1737950039000},"page":"1041-1051","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Efficacy, Safety, Pharmacokinetics, and Immunogenicity of\n                    <scp>ABBV<\/scp>\n                    \u2010154 in Adults With Glucocorticoid\u2010Dependent Polymyalgia Rheumatica: A Phase 2, Randomized, Double\u2010Blind, Placebo\u2010Controlled Trial"],"prefix":"10.1002","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2911-6800","authenticated-orcid":false,"given":"Robert F.","family":"Spiera","sequence":"first","affiliation":[{"name":"Hospital for Special Surgery and Weill Medical College of Cornell University  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0432-825X","authenticated-orcid":false,"given":"Valerie","family":"Devauchelle\u2010Pensec","sequence":"additional","affiliation":[{"name":"INSERM U 1227, Brest University Hospital  Brest France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire E.","family":"Owen","sequence":"additional","affiliation":[{"name":"Austin Clinical School, University of Melbourne  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4139-9295","authenticated-orcid":false,"given":"Federico","family":"D\u00edaz\u2010Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Hospital Universitario de Canarias and Universidad de La Laguna  La Laguna Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1111-8218","authenticated-orcid":false,"given":"Tsutomu","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Keio University School of Medicine, Shinjuku\u2010ku, Tokyo, and Saitama Medical University  Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edit","family":"Drescher","sequence":"additional","affiliation":[{"name":"Csolnoky Ferenc Hospital  Veszpr\u00e9m Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaclyn","family":"Anderson","sequence":"additional","affiliation":[{"name":"AbbVie Inc.  North Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dilek","family":"Arikan","sequence":"additional","affiliation":[{"name":"AbbVie Inc.  North Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronilda","family":"D'Cunha","sequence":"additional","affiliation":[{"name":"AbbVie Inc.  North Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Parmentier","sequence":"additional","affiliation":[{"name":"AbbVie Inc.  North Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise T.","family":"Kruzikas","sequence":"additional","affiliation":[{"name":"AbbVie Inc.  North Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weihan","family":"Zhao","sequence":"additional","affiliation":[{"name":"AbbVie Inc.  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North Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2534-550X","authenticated-orcid":false,"given":"Frank","family":"Buttgereit","sequence":"additional","affiliation":[{"name":"Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,4,2]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra011913"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207492"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780401022"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22777"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.2217\/ahe.11.50"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-021-05819-z"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.25216"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.110851"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41574-022-00683-6"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.5444"},{"key":"e_1_2_8_12_1","article-title":"FDA approves sarilumab for the treatment of adults with glucocorticoid\u2010resistant PMR","author":"Kaufman MB","year":"2023","journal-title":"The Rheumatologist website."},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.3c01174"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.1c02099"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27728"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2006.051979"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-008-1026-6"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.23095"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar3140"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10067-011-1914-z"},{"issue":"4","key":"e_1_2_8_21_1","first-page":"760","article-title":"Treatment of refractory polymyalgia rheumatica with infliximab: a pilot study","volume":"30","author":"Salvarani C","year":"2003","journal-title":"J Rheumatol"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-146-9-200705010-00005"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.34356"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2303452"}],"container-title":["Arthritis &amp; Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/art.43129","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T20:04:09Z","timestamp":1759953849000},"score":1,"resource":{"primary":{"URL":"https:\/\/acrjournals.onlinelibrary.wiley.com\/doi\/10.1002\/art.43129"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,2]]},"references-count":23,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2025,8]]}},"alternative-id":["10.1002\/art.43129"],"URL":"https:\/\/doi.org\/10.1002\/art.43129","archive":["Portico"],"relation":{},"ISSN":["2326-5191","2326-5205"],"issn-type":[{"value":"2326-5191","type":"print"},{"value":"2326-5205","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,2]]},"assertion":[{"value":"2024-08-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-02","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}