Rituximab as monotherapy and in combination with methotrexate or leflunomide in rheumatoid arthritis: a prospective cohort study in a Peruvian hospital

Liñán-Ponce F.; Leiva-Goicochea J.; Gross-Melo F. · Reumatologia (2026) · DOI: 10.5114/reum/213648

Resumen

Introduction: Rheumatoid arthritis (RA) is an autoimmune disease whose treatment has evolved with the introduction of disease-modifying antirheumatic drugs and biological agents such as rituximab (RTX). The objective of this study was to evaluate the efficacy, safety, and treatment adherence of RTX used as monotherapy and in combination with methotrexate (MTX) or leflunomide (LFN) in patients with RA refractory to conventional therapy. Material and methods: A prospective cohort study was conducted including 157 patients, divided into 3 groups: RTX monotherapy (n = 48), RTX + MTX (n = 66), and RTX + LFN (n = 43). Efficacy, safety, and adherence were evaluated at weeks 1, 24, and 48 using the Health Assessment Questionnaire (HAQ), Disease Activity Score in 28 joints (DAS28), American College of Rheumatology 70% response (ACR70), and Treat-to-Target (T2T) criteria. Ethical approval was obtained from the local institutional ethics committee. Results: All 3 therapeutic regimens demonstrated comparable clinical efficacy, with no statistically significant differences in disease activity scores. Adverse events were more frequent in the RTX + LFN group, although not statistically significant. Treatment adherence was highest in the RTX monotherapy group (100%). Conclusions: No significant differences in efficacy or safety were found among the 3 study groups; However, treatment adherence was significantly higher in the RTX monotherapy group (100%).