{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T05:09:50Z","timestamp":1782364190013,"version":"3.54.5"},"reference-count":26,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,7,25]],"date-time":"2024-07-25T00:00:00Z","timestamp":1721865600000},"content-version":"unspecified","delay-in-days":24,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie, Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2024,7,4]]},"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To evaluate the efficacy and safety of upadacitinib over 5 years among patients with rheumatoid arthritis (RA) in a long-term extension (LTE) of the SELECT-BEYOND phase 3 trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients refractory to \u22651 biological disease-modifying antirheumatic drug (DMARD) received upadacitinib 15\u2009mg or 30\u2009mg once daily or placebo, in combination with background conventional synthetic DMARD(s). At week 12, patients randomised to placebo were switched to upadacitinib 15\u2009mg or 30\u2009mg. All patients who completed the week 24 visit could enter the LTE for up to 5 years. Efficacy was analysed as observed and by non-responder imputation through week 260. Treatment-emergent adverse events per 100 patient-years were summarised over 5 years.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of the 498 patients randomised, 418 (84%) completed week 24 and entered the LTE. Of those who remained in the trial (n=80, upadacitinib 15\u2009mg; n=81, upadacitinib 30\u2009mg), 36%\/36% and 81%\/77% randomised to upadacitinib 15\/30\u2009mg were in Clinical Disease Activity Index (CDAI) remission or low disease activity at week 260, respectively (as observed). Approximately 47% of all patients who began in high disease activity demonstrated a CDAI improvement &gt;12 at week 260 with upadacitinib 15\/30\u2009mg. Functional and pain-related outcomes also showed comparable improvements with both doses. Numerically higher rates of anaemia, herpes zoster and creatine phosphokinase elevation were observed with upadacitinib 30\u2009mg vs 15\u2009mg. No new safety issues were identified.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Upadacitinib 15\/30\u2009mg continued to be effective in treating clinical and functional outcomes in patients with RA. The safety profile observed over 5 years was consistent with earlier study-specific and integrated assessments of upadacitinib treatment.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2023-003918","type":"journal-article","created":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T01:40:56Z","timestamp":1721958056000},"page":"e003918","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: results through 5 years from the SELECT-BEYOND study"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct02706847","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6630-1477","authenticated-orcid":false,"given":"Roy","family":"Fleischmann","sequence":"first","affiliation":[{"name":"University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Meerwein","sequence":"additional","affiliation":[{"name":"AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1768-7019","authenticated-orcid":false,"given":"Christina","family":"Charles-Schoeman","sequence":"additional","affiliation":[{"name":"Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4002-1861","authenticated-orcid":false,"given":"Bernard","family":"Combe","sequence":"additional","affiliation":[{"name":"Montpellier University, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Hall","sequence":"additional","affiliation":[{"name":"Rheumatology, Emeritus Research and Monash University, Melbourne, Victoria, 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