{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T21:54:07Z","timestamp":1781646847727,"version":"3.54.5"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T00:00:00Z","timestamp":1774828800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T00:00:00Z","timestamp":1778198400000},"content-version":"vor","delay-in-days":39,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Rheumatol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Patients with rheumatoid arthritis (RA) who have an inadequate response or intolerance to methotrexate require effective and safe alternative therapies. Baricitinib, a Janus kinase inhibitor, has shown efficacy in RA, but dose-dependent outcomes in developing countries remain limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To compare the efficacy and safety of baricitinib 2\u00a0mg versus 4\u00a0mg, both in combination with methotrexate, in patients with moderate-to-severe RA with an inadequate response to methotrexate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a 24-week, open-label, randomized controlled trial conducted in a developing country. Adult patients with moderate-to-severe RA and inadequate response or intolerance to methotrexate were randomly assigned (1:1) to receive either baricitinib 2\u00a0mg daily plus methotrexate 10\u00a0mg weekly or baricitinib 4\u00a0mg daily plus methotrexate 10\u00a0mg weekly. Primary outcome: proportion of patients achieving low disease activity (LDA) according to DAS28-CRP at week 24. Secondary endpoints included LDA by DAS28-ESR and Clinical Disease Activity Index (CDAI). The Simplified Disease Activity Index (SDAI), functional improvement assessed by the Bangla Health Assessment Questionnaire\u2013Disability Index (B-HAQ), and changes in core set outcomes and acute-phase reactants. Safety outcomes were assessed throughout the study. Analyses were conducted on an intention-to-treat basis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 94 patients were randomized, with 47 per treatment group. At week 24, LDA by DAS28-CRP was achieved by 38 patients (84.4%) in the baricitinib 4\u00a0mg group compared with 18 patients (45.0%) in the baricitinib 2\u00a0mg group (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.01). Remission alone occurred in 16 patients (35.6%) receiving 4\u00a0mg and six patients (15.0%) receiving 2\u00a0mg (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.03). LDA rates were also significantly higher in the 4\u00a0mg group, as assessed by CDAI (82.2% vs. 50.0%;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.01) and SDAI (80.0% vs. 47.5%;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.02). Except for erythrocyte sedimentation rate, all core set outcomes improved significantly more in the 4\u00a0mg group (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.05). Functional status improved significantly within both groups (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.05). Adverse events were generally mild to moderate. Herpes zoster occurred in two patients (4.5%) in the 4\u00a0mg group and one patient (2.5%) in the 2\u00a0mg group. No cases of tuberculosis, malignancy, venous thromboembolism, or death were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In patients with moderate-to-severe RA and an inadequate response to methotrexate, 4\u00a0mg baricitinib demonstrated superior efficacy compared with 2\u00a0mg baricitinib, with a comparable safety profile over 24 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      This study was registered with ClinicalTrials.gov (Identifier: NCT05660655,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05660655\" ext-link-type=\"uri\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05660655<\/jats:ext-link>\n                      ) on 13 December 2022.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s41927-026-00638-8","type":"journal-article","created":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T11:25:05Z","timestamp":1774869905000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Baricitinib in moderate to severe rheumatoid arthritis: dose-dependent efficacy and safety in a randomized clinical trial in a developing country"],"prefix":"10.1186","volume":"10","author":[{"given":"Md. 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