Evaluating the Efficacy of Immunomodulatory Therapies in Rheumatoid Arthritis: A Clinical Study
Nurlanovna O.A. Kallow Z.S. Jasim I.K. Al-Ani O.A.S. Magbul G. Zhumagaliuly A.
2025UK Scientific Publishing Limited
Trends in Immunotherapy
2025#9Issue 245 - 59 pp.
Rheumatoid arthritis (RA) is a systemic autoimmune disorder driven by aberrant cytokine-mediated signalling that perpetuates synovial inflammation and joint destruction. Baricitinib, an oral Janus kinase-1/2 inhibitor, offers a mechanism-based therapeutic option; however, comparative data clarifying its broader immunomodulatory advantages remain limited. We conducted a 24-week, multicentre, double-blind, randomised controlled trial to compare the efficacy and safety of baricitinib with the tumour-necrosis-factor inhibitor adalimumab and with placebo in adults with moderate-to-severe RA who had an inadequate response to conventional synthetic DMARDs. Three hundred participants were allocated equally (1:1:1) to once-daily baricitinib 4 mg, subcutaneous adalimumab 40 mg every other week, or matched placebo, all on stable methotrexate. Co-primary endpoints were (i) mean change from baseline in the Disease Activity Score using 28 joints and C-reactive protein (DAS28-CRP) and (ii) the proportion of patients achieving clinical remission (DAS28-CRP < 2.6) at week 24. Secondary outcomes included the Health Assessment Questionnaire-Disability Index (HAQ-DI), 36-Item Short-Form Survey (SF-36), radiographic progression via modified Total Sharp Score (mTSS), and comprehensive safety assessments. Baricitinib achieved a greater DAS28 reduction (−3.3 ± 0.9) than adalimumab (−2.9 ± 0.8) and placebo (−1.5 ± 0.7), with remission rates of 50%, 45%, and 20%, respectively. Baricitinib also produced superior improvements in HAQ-DI and SF-36 and curtailed radiographic progression versus placebo. Adverse events—predominantly mild upper-respiratory infections—were more frequent with baricitinib, yet serious events were comparable across groups.
Autoimmunity , Cytokine Signaling , Immunotherapy , JAK Inhibitors , Precision Medicine
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Department of Internal Medicine, Osh State University, Osh, 723500, Kyrgyzstan
Physical Therapy Department, Al Mansour University College, Baghdad, 10067, Iraq
Department of Pharmaceutics, Al-Turath University, Baghdad, 10013, Iraq
Department of Clinical Pharmacy, Al-Rafidain University College, Baghdad, 10064, Iraq
Technical of Medical Instruments Engineering Department, Madenat Alelem University College, Baghdad, 10006, Iraq
B. Atchabarov scientific- research institute of fundamental and applied medicine, Asfendiyarov Kazakh National Medical University, Almaty, 050000, Kazakhstan
Department of Internal Medicine
Physical Therapy Department
Department of Pharmaceutics
Department of Clinical Pharmacy
Technical of Medical Instruments Engineering Department
B. Atchabarov scientific- research institute of fundamental and applied medicine
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