{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T22:43:01Z","timestamp":1793400181592,"version":"4.5.0"},"reference-count":31,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2025,12,19]],"date-time":"2025-12-19T00:00:00Z","timestamp":1766102400000},"content-version":"unspecified","delay-in-days":79,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81501388"],"award-info":[{"award-number":["81501388"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82271817"],"award-info":[{"award-number":["82271817"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100022963","name":"Key Research and Development Program of Zhejiang Province","doi-asserted-by":"publisher","award":["2025C02089"],"award-info":[{"award-number":["2025C02089"]}],"id":[{"id":"10.13039\/100022963","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2025,11,23]]},"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This multicentre randomised controlled trial aimed to compare the efficacy and safety of iguratimod (IGU) and hydroxychloroquine (HCQ) in patients with active primary Sj\u00f6gren\u2019s syndrome (pSS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Eligible pSS patients were randomised 1:1 to receive IGU (25\u2009mg two times per day) or HCQ (0.2\u2009g two times per day) for 24 weeks. The primary endpoint was the Sj\u00f6gren\u2019s Syndrome Responder Index-30 (SSRI-30) response rate at week 24. Secondary endpoints included the Sj\u00f6gren\u2019s Tool for Assessing Response (STAR), European Alliance of Associations for Rheumatology (EULAR) Sj\u00f6gren\u2019s Syndrome Disease Activity Index (ESSDAI), EULAR Sj\u00f6gren\u2019s Syndrome Patient Reported Index (ESSPRI) and biomarker changes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 78 pSS patients were randomised (40 in HCQ group, 38 in IGU group) and 66 patients (35 in HCQ group, 31 in IGU group) completed the 24-week research. SSRI-30 response rate, the primary endpoint, was numerically higher in the IGU group (57.9% vs 40.0%, p=0.114), but with no statistical significance. However, IGU demonstrated significantly higher response rates for key secondary endpoints including STAR (39.5% vs 15.0%, p=0.015) and ESSDAI (21.1% vs 5.0%, p=0.034) response rate. IGU also showed superior IgG reduction (p=0.046). Adverse events were more frequent with IGU (60.6% vs 37.8%) but were mostly mild.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>IGU monotherapy demonstrated significant improvements in composite, systemic and serologic outcomes compared with HCQ in active pSS and was well-tolerated. These findings establish IGU as a promising therapeutic option for pSS, particularly in the subset of patients with hyperglobulinaemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04981145\">NCT04981145<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rmdopen-2025-006180","type":"journal-article","created":{"date-parts":[[2025,12,21]],"date-time":"2025-12-21T13:45:13Z","timestamp":1766324713000},"page":"e006180","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and safety of iguratimod in patients with primary Sj\u00f6gren\u2019s syndrome: a multicentre randomised controlled 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