{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T21:40:15Z","timestamp":1789594815471,"version":"build-2803163510"},"reference-count":17,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2023,6,28]],"date-time":"2023-06-28T00:00:00Z","timestamp":1687910400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To compare tofacitinib and methotrexate (MTX) as first\u2010line disease\u2010modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (RA).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This open\u2010label, randomized controlled, parallel\u2010group, 3\u2010month trial randomly assigned 100 RA patients to tofacitinib 10\u2009mg daily (49 patients) or MTX 25\u2009mg subcutaneously weekly (51 patients). The primary end point was low disease activity (LDA) measured with Disease Activity Score\u201028 with C\u2010reactive protein (DAS28\u2010CRP), and the secondary end point was LDA and remission measured by DAS28\u2010erythrocyte sedimentation rate (ESR), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index (SDAI). Health Assessment Questionnaire Disability Index (HAQ\u2010DI) response and mean reduction of core set of outcomes from baseline at 12\u2009weeks were also analyzed as secondary end points. In addition, acute\u2010phase reactants and composite measurements among groups were examined.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>LDA in DAS28\u2010CRP was achieved in 17 (34.7%) tofacitinib patients and 18 (35.3%) MTX patients (<jats:italic>p<\/jats:italic>\u2009=\u2009.95). Fourteen (28.6%) and 11 (21.6%) tofacitinib and\u00a0MTX patients, respectively, achieved LDA by DAS28\u2010ESR (<jats:italic>p<\/jats:italic>\u2009=\u2009.42). Tofacitinib and MTX groups achieved LDA similarly in CDAI (36.7% against 37.3%; <jats:italic>p<\/jats:italic>\u2009=\u2009.96) and SDAI (38.8% vs. 39.2%; <jats:italic>p<\/jats:italic>\u2009=\u2009.96). There was no significant difference in achieving remission between the groups. At 12\u2009weeks, tofacitinib reduced ESR and CRP (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.05). Composite measures and functional status decreased within groups but not between groups (<jats:italic>p<\/jats:italic>\u2009&gt;\u2009.05). Five (13.51%) tofacitinib patients developed hypertension. MTX caused gastrointestinal problems in 12 (30%) individuals. Two MTX (5%) and two tofacitinib (5.4%) patients had increased liver enzymes and renal impairment, respectively. Tofacitinib had 5.4% infection compared with 5% for MTX.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>As tofacitinib may be more effective than MTX according to previous reports such as the ORAL Start study, high\u2010dose MTX (25\u2009mg\/week, subcutaneously) used in this study may be as efficacious as tofacitinib in patients with established RA who were DMARD naive or had not received a therapeutic dose of DMARDs. However, adverse effects differed between groups.<\/jats:p><jats:p>Registered on: ClinicalTrials.gov; ID: NCT04464642.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1756-185x.14801","type":"journal-article","created":{"date-parts":[[2023,6,28]],"date-time":"2023-06-28T12:37:48Z","timestamp":1687955868000},"page":"1729-1736","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Tofacitinib versus methotrexate as the first\u2010line disease\u2010modifying antirheumatic drugs in the treatment of rheumatoid arthritis: An open\u2010label randomized controlled trial"],"prefix":"10.1111","volume":"26","author":[{"given":"Mohammad Mamun","family":"Khan","sequence":"first","affiliation":[{"name":"Department of Rheumatology Bangabandhu Sheikh Mujib Medical University  Dhaka Bangladesh"},{"name":"Department of Rheumatology Mymensingh Medical College Hospital  Mymensingh 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Bangladesh"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khandker","family":"Mahbub\u2010Uz\u2010Zaman","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Bangabandhu Sheikh Mujib Medical University  Dhaka Bangladesh"},{"name":"Department of Rheumatology Combined Military Hospital  Dhaka Bangladesh"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed Atiqul","family":"Haq","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Bangabandhu Sheikh Mujib Medical University  Dhaka Bangladesh"},{"name":"Green Life Center for Rheumatic Care and Research  Dhaka 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