Vnitr Lek 2025, 71(6):377-383 | DOI: 10.36290/vnl.2025.071
Advances in the diagnosis and treatment of systemic lupus erythematosus
- III. interní klinika - nefrologická, endokrinologická a revmatologická, FN a LF UP Olomouc
Advances in the research of targeted therapy have greatly expanded the treatment options for patients with systemic lupus erythematosus (SLE). Biological therapies have become an integral part of the new 2023 EULAR recommendations for the treatment of SLE and lupus nephritis. Biologic drugs (belimumab, anifrolumab) are indicated in the treatment of patients with severe forms of non-renal SLE without life-threatening organ involvement and severe neuropsychiatric manifestations, i.e. especially when extensive skin and joint involvement predominates; belimumab also has a role in the treatment of lupus nephritis. Rituximab is particularly indicated in the treatment of severe, refractory manifestations of SLE, including CNS involvement or severe cytopenia. A number of new molecules are currently being investigated, including obinutuzumab, dapirolizumab pegol and telitacicept, which appear particularly promising. There is already initial experience with CAR-T cell therapy and TCE therapy, which may have potential in the treatment of patients refractory to therapy. Further research into biomarkers may help identify patients with early forms of SLE or predict treatment response to a particular type of therapy.
Keywords: systemic lupus erythematosus, belimumab, anifrolumab, CAR-T therapy.
Accepted: September 21, 2025; Published: October 2, 2025 Show citation
References
- Horák P, Skácelová M, Schubertová M. Život ohrožující projevy systémového lupusu a antifosfolipidového syndromu ve vnitřním lékařství. Vnitř Lék. 2018;64(2):136-145.
Go to original source...
- Tian J, Zhang D, Yao X, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023;82(3):351-356.
Go to original source...
Go to PubMed...
- Fatoye F, Gebrye T, Mbada C. Global and regional prevalence and incidence of systemic lupus erythematosus in low-and-middle income countries: a systematic review and meta-analysis. Rheumatol Int. 2022;42(12):2097-2107.
Go to original source...
Go to PubMed...
- Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019;71(9):1400-1412.
Go to original source...
Go to PubMed...
- Mai L, Asaduzzaman A, Noamani B, et al. The baseline interferon signature predicts disease severity over the subsequent 5 years in systemic lupus erythematosus. Arthritis Res Ther. 2021;23:29.
Go to original source...
Go to PubMed...
- Matsuoka N, Fujita Y, Temmoku J, et al. Galectin-9 as a biomarker for disease activity in systemic lupus erythematosus. PLoS One. 2020;15:e0227069.
Go to original source...
Go to PubMed...
- Zhao M, Zhou Y, Zhu B, et al. IFI44L promoter methylation as a blood biomarker for systemic lupus erythematosus. Ann Rheum Dis. 2016;75(11):1998-2006.
Go to original source...
Go to PubMed...
- Yan L, Jiang L, Wang B, et al. Novel microRNA biomarkers of systemic lupus erythematosus in plasma: miR-124-3p and miR-377-3p. Clin Biochem. 2022;107:55-61.
Go to original source...
Go to PubMed...
- Zhang RJ, Zhang X, Chen J, et al. Serum soluble CD25 as a risk factor of renal impairment in systemic lupus erythematosus - a prospective cohort study. Lupus. 2018;27:1100-1106.
Go to original source...
Go to PubMed...
- Italiani P, Manca M, Angelotti F, et al. IL-1 family cytokines and soluble receptors in systemic lupus erythematosus. Arthritis Res Ther. 2018;20:27.
Go to original source...
Go to PubMed...
- Suh CH, Kim SS, Hong SJ, et al. Novel diagnostic biomarker of systemic lupus erythematosus - antichaperonin containing T-complex peptide 1 antibody. J Rheumatol. 2025;52(Suppl 1):99-100.
Go to original source...
- Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024;83:15-29.
Go to original source...
Go to PubMed...
- Kidney Disease: Improving Global Outcomes (KDIGO) Lupus Nephritis Work Group. KDIGO 2024 Clinical Practice Guideline for the Management of Lupus Nephritis. Kidney Int. 2024;105(1S):S1-S69.
Go to original source...
Go to PubMed...
- Horák P. Principy léčby SLE dle aktualizovaných doporučení EULAR 2023 - komentář. Čes Revmatol. 2024;32(3):107-115.
- www.sukl.cz. Available from: https://www.sukl.cz
- Wallace DJ, Stohl W, Furie RA, et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Care Res. 2009;61:1168-1178.
Go to original source...
Go to PubMed...
- Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63:3918-3930.
Go to original source...
Go to PubMed...
- Navarra SV, Guzman RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377:721-731.
Go to original source...
Go to PubMed...
- Stohl W, Schwarting A, Okada M, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two-week randomized, double-blind placebo-controlled study. Arthritis Rheumatol. 2017;69:1016-1027.
Go to original source...
Go to PubMed...
- Zhang F, Bae SC, Bass D, et al. A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea. Ann Rheum Dis. 2018;77:355-363.
Go to original source...
Go to PubMed...
- Furie R, Rovin BH, Houssiau F, et al. Two-year, randomized, controlled trial of Belimumab in lupus nephritis. N Engl J Med. 2020;383:1117-28.
Go to original source...
Go to PubMed...
- Atisha-Fregoso Y, Malkiel S, Harris KM, et al. Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis. Arthritis Rheumatol Hoboken NJ. https://doi.org/10.1002/ art. 41466. Epub ahead of print 4 August 2020.
- Furie R, Khamashta M, Merrill JT, et al. Anifrolumab, an Anti-Interferon-α Receptor Monoclonal Antibody, in moderate-to-severe systemic lupus erythematosus: Anifrolumab in moderate-to-severe SLE. Arthritis Rheumatol. 2017;69:376-86.
Go to original source...
Go to PubMed...
- Furie RA, Morand EF, Bruce IN, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1:e208-19.
Go to original source...
Go to PubMed...
- Morand EF, Furie R, Tanaka Y, et al. Trial of Anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382:211-21.
Go to original source...
Go to PubMed...
- Jayne D, Rovin B, Mysler F, et al. Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. Ann Rheum Dis. 2022;81:496-506.
Go to original source...
Go to PubMed...
- Merrill JT, Neuwelt CM, Wallace DJ et al. Efficacy and safety of rituximab in moderately- -to -severely active systemic lupus erythematosus: the randomized, double -blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010 Jan;62(1):222-33.
Go to original source...
Go to PubMed...
- Rovin BH, Furie R, Latinis K, et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum. 2012 Apr;64(4):1215-26. doi: 10.1002/art.34359. Epub 2012 Jan 9. PMID: 22231479.
Go to original source...
Go to PubMed...
- Gomez Mendez LM, Cascino MD, Garg J, et al. Peripheral blood B cell depletion after rituximab and complete response in lupus nephritis. Clin J Am Soc Nephrol. 2018;13:1502-9.
Go to original source...
Go to PubMed...
- Kalunian KC, Merrill JT, Maciuca R, et al. A phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-α) in patients with systemic lupus erythematosus (ROSE). Ann Rheum Dis. 2016;75:196-202.
Go to original source...
Go to PubMed...
- Khamashta M, Merrill JT, Werth VP, et al. Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016;75:1909-1916.
Go to original source...
Go to PubMed...
- Furie R, Dooley MA, Wofsy D, et al. A phase III randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of abatacept or placebo on standard of care in patients with active class III or IV lupus nephritis. Ann Rheum Dis. 2018;77:176-177.
Go to original source...
- Furie RA, Leon G, Thomas M, et al. A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study. Ann Rheum Dis. 2015;74:1667-1675.
Go to original source...
Go to PubMed...
- Merrill JT, Shanahan WR, Scheinberg M, et al. Phase III trial results with blisibimod, a selective inhibitor of B-cell activating factor, in subjects with systemic lupus erythematosus (SLE): results from a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2018;77:883-889.
Go to original source...
Go to PubMed...
- Isenberg DA, Petri M, Kalunian K, et al. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016;75:323-331.
Go to original source...
Go to PubMed...
- Merrill JT, van Vollenhoven RF, Buyon JP, et al. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016;75:332-340.
Go to original source...
Go to PubMed...
- Isenberg D, Gordon C, Licu D, et al. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2015;74:2006-2015.
Go to original source...
Go to PubMed...
- Wu D, Li J, Xu D, et al. Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2 b, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2024;83:475-487.
Go to original source...
Go to PubMed...
- Furie R, Aroca G, Alvarez A, et al. A phase II randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of obinutuzumab or placebo in combination with mycophenolate mofetil in patients with active class III or IV lupus nephritis [abstract]. Arthritis Rheumatol. 2019;71(Suppl 10).
- Mysler EF, Spindler AJ, Guzman R, et al. Efficacy and safety of ocrelizumab in active proliferative lupus nephritis: results from a randomized, double-blind, phase III study. Arthritis Rheum. 2013;65:2368-2379.
Go to original source...
Go to PubMed...
- van Vollenhoven RF, Hahn BH, Tsokos GC, et al. Efficacy and safety of ustekinumab, an IL-12 and IL-23 inhibitor, in patients with active systemic lupus erythematosus: results of a multicentre, double-blind, phase 2, randomised, controlled study. Lancet. 2018;392:1330-1339.
Go to original source...
Go to PubMed...
- Furie RA, Bruce IN, Dörner T, et al. Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus. Rheumatology. 2021;60:5397-5407.
Go to original source...
Go to PubMed...
- Clowse M, Isenberg D, Merrill J, et al. Dapirolizumab pegol demonstrated significant improvement in systemic lupus erythematosus disease activity: efficacy and safety results of a phase 3 trial [abstract]. Arthritis Rheumatol. 2024;76(Suppl 9). Available from: https://acrabstracts.org/abstract/dapirolizumab-pegol-demonstrated-significant-improvement-in-systemic-lupus-erythematosus-disease-activity-efficacy-and-safety-results-of-a-phase-3-trial/ [cited 2025 Jul 12].
- Furie RA, van Vollenhoven RF, Kalunian K, et al. Trial of anti-BDCA2 antibody litifilimab for systemic lupus erythematosus. N Engl J Med. 2022;387:894-904.
Go to original source...
Go to PubMed...
- Merrill JT, Tanaka Y, D'Cruz D, et al. Efficacy and safety of upadacitinib or elsubrutinib alone or in combination for patients with systemic lupus erythematosus: a phase 2 randomized controlled trial. Arthritis Rheumatol. 2024;76:1518-1529.
Go to original source...
Go to PubMed...
- Morand E, Pike M, Merrill JT, et al. Deucravacitinib, a tyrosine kinase 2 inhibitor, in systemic lupus erythematosus: a phase II, randomized, double-blind, placebo-controlled trial. Arthritis Rheumatol. 2023;75:242-252.
Go to original source...
Go to PubMed...
- Chan J, Walters GD, Puri P, et al. Safety and efficacy of biological agents in the treatment of systemic lupus erythematosus (SLE). BMC Rheumatol. 2023;7:37.
Go to original source...
Go to PubMed...
- Schett G, Mackensen A, Mougiakakos D. CAR T-cell therapy in autoimmune diseases. Lancet. 2023;402:2034-2044.
Go to original source...
Go to PubMed...
- Schett G, Müller F, Taubmann J, et al. Advancements and challenges in CAR T cell therapy in autoimmune diseases. Nat Rev Rheumatol. 2024;20:531-544.
Go to original source...
Go to PubMed...
- Mackensen A, Müller F, Mougiakakos D, et al. Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nat Med. 2022;28:2124-2132.
Go to original source...
Go to PubMed...
- Hagen M, Bucci L, Böltz S, et al. BCMA-targeted T-cell-engager therapy for autoimmune disease. N Engl J Med. 2024;391:867-869.
Go to original source...
Go to PubMed...
- Alexander T, Krönke J, Cheng Q, et al. Teclistamab-induced remission in refractory systemic lupus erythematosus. N Engl J Med. 2024;391:864-866.
Go to original source...
Go to PubMed...
- Bucci L, Hagen M, Rothe T, et al. Bispecific T cell engager therapy for refractory rheumatoid arthritis. Nat Med. 2024;30:1593-1601.
Go to original source...
Go to PubMed...
- Parodis I, Girard-Guyonvarc'h C, Arnaud L, et al. EULAR recommendations for the non-pharmacological management of systemic lupus erythematosus and systemic sclerosis. Ann Rheum Dis. 2024;83(6):720-729.
Go to original source...
Go to PubMed...
- Saegusa K, Tsuchida Y, Komai T, et al. Advances in targeted therapy for systemic lupus erythematosus: current treatments and novel approaches. Int J Mol Sci. 2025;26(3):929.
Go to original source...
Go to PubMed...