Observational studyClinical rheumatology2026
Upfront low-dose biosimilar rituximab as first biologic therapy after triple csDMARD failure in seropositive rheumatoid arthritis: a prospective real-world strategy study.
Observational study in Clinical rheumatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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5 authors.
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Abstract
introductionLimited access to biologic disease-modifying antirheumatic drugs (bDMARDs) in resource-constrained settings influences treatment sequencing after failure of conventional synthetic DMARDs (csDMARDs). Evidence regarding upfront use of low-dose rituximab as first biologic therapy remains limited. This study aimed to evaluate the effectiveness and steroid-sparing potential of upfront low-dose biosimilar rituximab in biologic-naïve patients with seropositive rheumatoid arthritis refractory to maximally tolerated triple csDMARD therapy.
methodsThis prospective single-centre observational study included biologic-naïve anti-CCP-positive rheumatoid arthritis patients with inadequate response to ≥ 6 months of methotrexate, hydroxychloroquine, and sulfasalazine. Patients received two infusions of biosimilar rituximab (500 mg each) administered 2 weeks apart while continuing background csDMARDs. Disease activity was assessed using DAS28-ESR at baseline and weeks 2, 6, 12, and 24. Longitudinal changes were analyzed using Friedman and Wilcoxon signed-rank tests.
resultsSeventy-five patients (88% women) were included. Mean DAS28-ESR decreased from 5.57 at baseline to 2.78 at week 24 (p < 0.001), with a median reduction of 2.7 points. Remission rates increased from 0% to 50.7% at 24 weeks. Mean tender joint count declined from 9.43 to 1.33 and swollen joint count from 4.43 to 0.37. All patients discontinued corticosteroids during follow-up. Infusion reactions were mild, and no mortality occurred.
conclusionsUpfront low-dose biosimilar rituximab as first biologic therapy achieved significant and sustained disease activity reduction with high remission rates and successful steroid withdrawal, supporting a rituximab-first strategy in resource-limited public health settings. Key Points • Upfront low-dose biosimilar rituximab (500 mg × 2) significantly reduced disease activity in biologic-naïve, seropositive rheumatoid arthritis after triple csDMARD failure. • Mean DAS28-ESR decreased from 5.57 to 2.78 at 24 weeks, with 50.7% of patients achieving remission. • All patients discontinued corticosteroids, and 50% discontinued both sulfasalazine and hydroxychloroquine during follow-up.
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