Bieżący numer
Archiwum
Online first
O czasopiśmie
Redakcja
Rada Naukowa
Wydawca
Standardy etyczne i procedury
Bazy indeksacyjne
Recenzenci
Recenzenci Honorowi
Prenumerata
Kontakt
Najczęściej czytane artykuły
Dla autorów
Opłata za przetwarzanie artykułu (APC)
Książki i Konferencje
Książki
Konferencje
SARS CoV-2/COVID-19
PRACA ORYGINALNA
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
Data nadesłania: 07-07-2025
Data ostatniej rewizji: 14-10-2025
Data akceptacji: 27-10-2025
Data publikacji: 27-02-2026
Autor do korespondencji
Reumatologia 2026;64(1):4-10
SŁOWA KLUCZOWE
DZIEDZINY
STRESZCZENIE
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%).
REFERENCJE (23)
1.
Gao Y, Zhang Y, Liu X. Rheumatoid arthritis: pathogenesis and therapeutic advances. MedComm (2020) 2024; 5: e509, DOI: 10.1002/mco2.509.
2.
Firestein GS. Pathogenesis of rheumatoid arthritis: the intersection of genetics and epigenetics. Trans Am Clin Climatol Assoc 2018; 129: 171–182.
3.
Rezus E, Codreanu C. From pathogenesis to treatment: new insights in rheumatology. Int J Mol Sci 2023; 24: 15590, DOI: 10.3390/ijms242115590.
4.
Friedman B, Cronstein B. Mechanism of methotrexate in the treatment of rheumatoid arthritis. Joint Bone Spine 2019; 86: 301–307, DOI: 10.1016/j.jbspin.2018.07.004.
5.
Findeisen KE, Sewell J, Ostor AJK. Biologic therapies for rheumatoid arthritis: an overview for clinicians. Biologics 2021; 15: 343–352, DOI: 10.2147/btt.s252575.
6.
García-Montoya L, Villota-Eraso C, Yusof MYM, et al. Lessons from rituximab treatment in patients with rheumatoid arthritis. Lancet Rheumatol 2020; 2: e497–509, DOI: 10.1016/S2665-9913(20)30033-3.
7.
Bafana SS, Alenzi F, Almaghlouth I, et al. Use of rituximab in rheumatoid arthritis: a seven-year retrospective study of 52 patients in a Saudi Arabian hospital. Med Sci Monit 2024; 30: e946178, DOI: 10.12659/MSM.946178.
8.
Smolen JS, Landewé R, Bergstra SA. EULAR recommendations for the treatment of rheumatoid arthritis with synthetic and biologic DMARDs: 2022 update. Ann Rheum Dis 2023; 82: 3–18, DOI: 10.1136/ard-2022-223356corr1.
9.
Detert J, Klaus P. Biologic monotherapy in the treatment of rheumatoid arthritis. Biologics 2015; 9: 35–43, DOI: 10.2147/btt.s53361.
10.
Emery P, Pope JE, Kruger K, et al. Efficacy of biologic and JAK inhibitor monotherapy for the treatment of rheumatoid arthritis: a systematic review. Adv Ther 2018; 35: 1535–1563, DOI: 10.1007/s12325-018-0757-2.
11.
De Castro CT, De Queiroz MJ, Albuquerque FC, et al. Clinical practice effectiveness of biologic therapy in patients with rheumatoid arthritis: a systematic review and meta-analysis. Front Pharmacol 2022; 13: 927179, DOI: 10.3389/fphar.2022.927179.
12.
De Queiroz MJ, De Castro CT, Albuquerque FC, et al. Safety of biologic therapy in patients with rheumatoid arthritis in administrative health databases: a systematic review and meta-analysis. Front Pharmacol 2022; 13: 928471, DOI: 10.3389/fphar.2022.928471.
13.
Wang Z, Bao HW, Ji Y. Systematic review and meta-analysis of rituximab combined with methotrexate versus methotrexate alone in the treatment of rheumatoid arthritis. Medicine (Baltimore) 2020; 99: e19193, DOI: 10.1097/MD.0000000000019193.
14.
Koehm M, Foldenauer AC, Rossmanith T, et al. Efficacy of different doses of rituximab combined with leflunomide in the treatment or retreatment of rheumatoid arthritis: part 2 of the AMARA randomized, placebo-controlled, investigator-initiated trial. J Clin Med 2022; 11: 7316, DOI: 10.3390/jcm11247316.
15.
Behrens F, Koehm M, Rossmanith T, et al. Rituximab plus leflunomide in rheumatoid arthritis: the AMARA randomized, placebo-controlled, investigator-initiated study. Rheumatology (Oxford) 2021; 60: 5318–5328, DOI: 10.1093/rheumatology/keab153.
16.
Sebastiani M, Atzeni F, Bazzani C, et al. Efficacy and safety of rituximab with and without methotrexate in the treatment of patients with rheumatoid arthritis: results from the GISEA registry. Joint Bone Spine 2014; 81: 508–512, DOI: 10.1016/j.jbspin.2014.06.011.
17.
Richter A, Strangfeld A, Herzer P, et al. Sustainability of rituximab therapy in different treatment strategies: results from a 3-year follow-up of a German biologics register. Arthritis Care Res (Hoboken) 2014; 66: 1627–1633, DOI: 10.1002/acr.22327.
18.
Edwards JCW, Szczepański L, Szechiński J, et al. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med 2004; 350: 2572–2581, DOI: 10.1056/NEJMoa032534.
19.
Chatzidionysiou K, Lie E, Nasonov E, et al. Effectiveness of methotrexate and leflunomide as background therapy in rheumatoid arthritis patients treated with rituximab: one-year follow-up results from the CERERRA collaboration. Ann Rheum Dis 2012; 71: 374–377, DOI: 10.1136/annrheumdis-2011-200003.
20.
Raiter R, Rimer D, Boulman N, et al. Sustainability of rituximab in concomitant treatment with methotrexate or leflunomide in rheumatoid arthritis patients. Harefuah 2017; 156: 415–417.
21.
Cohen MD, Keystone E. Rituximab for rheumatoid arthritis. Rheumatol Ther 2015; 2: 99–111, DOI: 10.1007/s40744-015-0016-9.
22.
Łosińska K, Wilk M, Pripp AH, et al. Long-term drug effectiveness and survival for reference rituximab in rheumatoid arthritis patients in an ordinary outpatient clinic. Sci Rep 2022; 12: 8283, DOI: 10.1038/s41598-022-12271-9.
23.
Shi Y, Wu Y, Ren Y, et al. Infection risks of rituximab treatment versus non-rituximab therapy for rheumatoid arthritis: a systematic review and meta-analysis. Int J Rheum Dis 2019; 22: 1361–1370, DOI: 10.1111/1756-185X.13596.
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.
Udostępnij
ARTYKUŁ POWIĄZANY
| eISSN: | 2084-9834 |
| ISSN: | 0034-6233 |
Przetwarzamy dane osobowe zbierane podczas odwiedzania serwisu. Realizacja funkcji pozyskiwania informacji o użytkownikach i ich zachowaniu odbywa się poprzez dobrowolnie wprowadzone w formularzach informacje oraz zapisywanie w urządzeniach końcowych plików cookies (tzw. ciasteczka). Dane, w tym pliki cookies, wykorzystywane są w celu realizacji usług, zapewnienia wygodnego korzystania ze strony oraz w celu monitorowania ruchu zgodnie z Polityką prywatności. Dane są także zbierane i przetwarzane przez narzędzie Google Analytics (więcej).
Możesz zmienić ustawienia cookies w swojej przeglądarce. Ograniczenie stosowania plików cookies w konfiguracji przeglądarki może wpłynąć na niektóre funkcjonalności dostępne na stronie.
Możesz zmienić ustawienia cookies w swojej przeglądarce. Ograniczenie stosowania plików cookies w konfiguracji przeglądarki może wpłynąć na niektóre funkcjonalności dostępne na stronie.
