Multidisciplinary position statement on the treatment of lupus nephritis with voclosporin
Authors:
R. Ryšavá 1; I. Rychlík 2; O. Viklický 3; P. Horák 4; J. Závada 5; L. Šenolt 5; V. Tesař 1
Authors‘ workplace:
Nefrologická klinika 1. LF UK a VFN, Praha
1; Interní klinika 3. LF UK a FNKV, Praha
2; Klinika nefrologie IKEM, Praha
3; III. Interní klinika – nefrologická, revmatologická a endokrinologická UP a FN, Olomouc
4; Revmatologický ústav Praha
5
Published in:
Čes. Revmatol., 32, 2024, No. 4, p. 166-169.
Category:
Úvodník
Overview
Voclosporin is a new calcineurin inhibitor that is currently being introduced in the treatment of lupus nephritis in the Czech Republic. It is the first and only drug in this class officially approved for the treatment of this condition. Voclosporin has been tested in lupus nephritis in a phase 2 clinical trial (AURA-LV), a phase 3 clinical trial (AURORA 1), and an ongoing two-year study (AURORA 2). All three studies demonstrated that the combination of voclosporin with mycophenolate mofetil and corticosteroids is more effective than mycophenolate mofetil, corticosteroids, and placebo in achieving a renal response (both complete and primary effective therapeutic response). Moreover, the treatment was well tolerated. Based on these studies, the combination therapy of voclosporin, mycophenolate mofetil, and corticosteroids has become one of the four possible treatment options for lupus nephritis according to current nephrology and rheumatology guidelines, both in the induction and maintenance phases of treatment. The present position statement from a group of experts aims to inform the broader public about the drug Lupkynis (active compound: voclosporin) in the treatment of patients with lupus nephritis.
Keywords:
Glomerular filtration – Proteinuria – Lupus nephritis – calcineurin inhibitors – voclosporin
Sources
1. Hanly JG, O’Keeffe AG, Su L, et al. The frequency and outcome of lupus nephritis: results from an international inception cohort study. Rheumatology (Oxford) 2016; 55(2): 252–262.
2. Tektonidou MG, Dasgupta A, Ward MM. Risk of end-stage renal disease in patients with lupus nephritis, 1971–2015: a systematic review and bayesian meta-analysis. Arthritis Rheumatol. 2016; 68(6): 1432–1441.
3. Mahajan A, Amelio J, Gairy K, et al. Systemic lupus erythematosus, lupus nephritis and end-stage renal disease: a pragmatic review mapping disease severity and progression. Lupus 2020; 29(9): 1011–1020.
4. KDIGO 2024 Clinical Practice Guideline for the management of LUPUS NEPHRITIS. Kidney Int. 2024; 105(Suppl 1S): S1–S69.
5. Tamirou F, Lauwerys BR, Dall’Era M, et al. A proteinuria cut-off level of 0.7 g/day after 12 months of treatment best predicts long-term renal outcome in lupus nephritis: data from the MAINTAIN Nephritis Trial. Lupus Sci Med. 2015; 2(1): e000123.
6. Rovin BH, Solomons N, Pendergraft WF 3rd, et al. A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis. Kidney Int. 2019; 95(1): 219–231.
7. Rovin BH, Teng YKO, Ginzler EM, et al. Efficacy and safety of voclosporin versus placebo for lupus nephritis (Aurora 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 2021; 397(10289): 2070–2080.
8. Saxena A, Ginzler EM, Gibson E, et al. Safety and Efficacy of Long-Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial. Arthritis Rheumatol. 2024; 76(1): 59–67.
9. 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.
10. Menn-Josephy H, Hodge LS, Birardi V. Leher H. Efficacy of voclosporin in proliferative lupus nephritis with high levels of proteinuia. CJASN 2024; 19: 309–318.
11. Frangau E, Bruchfeld A, Fernandez-Juarez GM, et al. EULAR 2023 recommendations for SLE treatment: synopsis for the management of lupus nephritis – the European Renal Association (ERA) – Immunonephrology Working Group (ERA-IWG) perspective. Nephrol Dial Transplant. 2024; 39(5): 727–730.
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Dermatology & STDs Paediatric rheumatology RheumatologyArticle was published in
Czech Rheumatology
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