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ORIGINAL PAPER
Rituximab as monotherapy and in combination with methotrexate or leflunomide in rheumatoid arthritis: a prospective cohort study in a Peruvian hospital
1
Victor Lazarte Echegaray Hospital, Trujillo, Peru
Submission date: 2025-07-07
Final revision date: 2025-10-14
Acceptance date: 2025-10-27
Publication date: 2026-02-27
Corresponding author
Reumatologia 2026;64(1):4-10
KEYWORDS
TOPICS
ABSTRACT
Objectives:
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%).
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%).
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Copyright: © Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji w Warszawie. This is an Open Access journal, all articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License (https://creativecommons.org/licenses/by-nc-sa/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
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