Comparative efficacy of rituximab in biologic/targeted synthetic DMARD-naive versus exposed rheumatoid arthritis patients: a retrospective cohort study

Year 2025, Volume: 16 Issue: 55, 84 - 91, 18.08.2025

Sertaç Ketenci , Mete Kara

https://doi.org/10.17944/interdiscip.1667814

Abstract

Objective: To compare the efficacy and safety of rituximab in patients with rheumatoid arthritis (RA) who were either biologic/targeted synthetic DMARD (bDMARD/tsDMARD)-naive or previously exposed.
Methods: In this retrospective cohort study, 120 RA patients treated with rituximab between June 2020 and December 2023 were included. Patients were categorized as bDMARD/tsDMARD-naive (n=66) or -exposed (n=54). Clinical efficacy was assessed by change in Disease Activitity Score 28 (DAS28)-CRP and the proportion achieving low disease activity (LDA; DAS28-CRP <3.2) after treatment. Safety outcomes included infusion-related reactions (IRRs), infections, and hypogammaglobulinemia.
Results: The naive group showed significantly greater improvement in disease activity (ΔDAS28-CRP: 2.5 vs. 1.9, p=0.001) and higher LDA achievement (62.1% vs. 46.2%, p=0.030) compared to the exposed group. Rates of IRRs (16.6% vs. 18.5%, p=0.820), infections (1.5% vs. 1.9%, p=0.880), and hypogammaglobulinemia were comparable between groups. Most IRRs were mild (grade 1–2); only one serious IRR occurred, with no cases requiring prolonged hospitalization. One patient in the exposed group experienced hepatitis B reactivation, managed effectively with antiviral therapy. Primary and secondary inefficacy were the most common reasons for rituximab discontinuation, with no significant differences between groups.
Conclusion: Rituximab demonstrated superior efficacy in bDMARD/tsDMARD-naive RA patients, while maintaining a comparable safety profile to that in previously exposed patients. These findings support the potential benefit of using Rituximab earlier in the treatment sequence for selected RA patients.

Keywords

Rituximab, rheumatoid arthritis, biologic drug, treatment outcome, infusion-related reactions

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