Secukinumab in active lupus nephritis: results from a phase III randomized, placebo-controlled study (SELUNE) and an open-label extension study
| datacite.rights | http://purl.org/coar/access_right/c_abf2 | |
| dc.contributor.author | Hui Zhao, Ming | |
| dc.contributor.author | Cons Molina, Fidencio | |
| dc.contributor.author | Aroca, Gustavo | |
| dc.contributor.author | Tektonidou, Maria G. | |
| dc.contributor.author | Mathur, Anubhav | |
| dc.contributor.author | Tangadpalli, Radhika | |
| dc.contributor.author | Sun, Rui | |
| dc.contributor.author | Martin, Ruvie | |
| dc.contributor.author | Pellet, Pascale | |
| dc.contributor.author | Phuong Huynh, Thao Ngoc | |
| dc.date.accessioned | 2026-04-08T13:58:56Z | |
| dc.date.available | 2026-04-08T13:58:56Z | |
| dc.date.issued | 2026 | |
| dc.description.abstract | LN occurs in 50% of patients with SLE and is associated with significant morbidity and mortality [1]. The current management of LN is based on disease severity and includes CSs, anti-malarial agents, and CS-sparing immunosuppressive agents. Despite the availability of new therapeutic options, the trials and observational studies have shown a complete renal response (CRR) of <50%, and the long-term effects of these therapeutic options are not yet known [2]. Therefore, LN management remains challenging. Without effective control of disease activity, patients may develop end-stage kidney disease (ESKD) and ultimately need renal replacement therapy [1, 3]. The evidence suggests that 6% to 19% of patients with LN develop ESKD over 10 years [3–5]. Recently, the Lupus Midwest Network (LUMEN) registry revealed that the survival rate for LN was 70%, and that 13% of patients with LN developed ESKD at 10 years [4]. Therefore, even with the current treatments, the risk of kidney failure remains high, highlighting the unmet treatment need in LN. In addition, factors such as limited access to specialized lupus centres and poor treatment adherence significantly impact outcomes in LN. These barriers contribute to delayed diagnosis and suboptimal disease control, underscoring the need for holistic management strategies [6]. The pathophysiology of LN is complex and is characterized by autoantibody production and inflammatory cell infiltration into renal tissues. IL-17–producing Th type 17 (Th17) cells exhibit significant hyperactivation, leading to inflammation, which has been implicated in LN-associated kidney damage [7, 8]. Moreover, IL-17 stimulates inflammatory cytokine production by renal cells, leading to granulopoiesis as well as changes in renal function [9]. Thus, IL-17 may contribute to disease progression, and its inhibition may lead to clinical improvement in LN [10]. Secukinumab, an anti–IL-17A antibody, has shown efficacy with a consistent and favourable safety profile in psoriasis, PsA, axial SpA, and hidradenitis suppurativa [11, 12]. Previous case reports have suggested improvement in LN with secukinumab [13, 14]. A patient with refractory LN achieved a CRR within 8 months of secukinumab treatment [13]. A phase III core study (SELUNE) and an extension study were conducted to evaluate the efficacy and safety of s.c. secukinumab 300 mg compared with placebo, in combination with the standard of care (SoC) for patients with active LN. Both studies were terminated early due to futile results following a planned futility analysis of the core study. The final results of the two studies are reported herein. | eng |
| dc.format.mimetype | ||
| dc.identifier.citation | Ming-hui Zhao, Fidencio Cons Molina, Gustavo Aroca, Maria G Tektonidou, Anubhav Mathur, Radhika Tangadpalli, Rui Sun, Ruvie Martin, Pascale Pellet, Thao Ngoc Phuong Huynh, Secukinumab in active lupus nephritis: results from a phase III randomized, placebo-controlled study (SELUNE) and an open-label extension study, Rheumatology, Volume 65, Issue 1, January 2026, keaf536, https://doi.org/10.1093/rheumatology/keaf536 | |
| dc.identifier.doi | https://doi.org/10.1093/rheumatology/keaf536 | |
| dc.identifier.issn | 1462-0332 (electrónico) | |
| dc.identifier.issn | 1462-0324 (Impreso) | |
| dc.identifier.uri | https://hdl.handle.net/20.500.12442/17503 | |
| dc.identifier.url | https://academic.oup.com/rheumatology/article/65/1/keaf536/8286944 | |
| dc.language.iso | eng | |
| dc.publisher | Oxford University Press | spa |
| dc.publisher | British Society for Rheumatology | spa |
| dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International | eng |
| dc.rights.accessrights | info:eu-repo/semantics/openAccess | |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | |
| dc.source | Rheumatology | eng |
| dc.source | Vol. 66 No. 1 Año 2026 | spa |
| dc.subject.keywords | Biologic therapies | eng |
| dc.subject.keywords | Clinical trials and methods | eng |
| dc.subject.keywords | Interventional studies | eng |
| dc.subject.keywords | Renal | eng |
| dc.subject.keywords | Systemic lupus erythematosus | eng |
| dc.subject.keywords | Autoimmunity | eng |
| dc.title | Secukinumab in active lupus nephritis: results from a phase III randomized, placebo-controlled study (SELUNE) and an open-label extension study | eng |
| dc.type.driver | info:eu-repo/semantics/article | |
| dc.type.spa | Artículo científico | |
| dcterms.references | Parikh SV, Almaani S, Brodsky S et al. Update on lupus nephritis: core curriculum 2020. Am J Kidney Dis 2020;76:265–81. | eng |
| dcterms.references | Parodis I, Depascale R, Doria A et al. When should targeted therapies be used in the treatment of lupus nephritis: early in the disease course or in refractory patients? Autoimmun Rev 2024;23:103418. | eng |
| dcterms.references | 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;68:1432–41. | eng |
| dcterms.references | Hocaóglu M, Valenzuela-Almada MO, Dabit JY et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades using the Lupus Midwest Network. Arthritis Rheumatol 2023;75:567–73. | eng |
| dcterms.references | 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;29:1011–20. | eng |
| dcterms.references | Mok CC, Teng YO, Saxena R et al. Treatment of lupus nephritis: consensus, evidence and perspectives. Nat Rev Rheumatol 2023; 19:227–38. | eng |
| dcterms.references | Zickert A, Amoudruz P, Sundstrom € Y et al. IL-17 and IL-23 in lupus nephritis—association to histopathology and response to treatment. BMC Immunol. 2015;16:7. | eng |
| dcterms.references | Xing Q, Wang B, Su H et al. Elevated Th17 cells are accompanied by FoxP3þ Treg cells decrease in patients with lupus nephritis. Rheumatol Int 2012;32:949–58. | eng |
| dcterms.references | Paquissi FC, Abensur H. The Th17/IL-17 axis and kidney diseases, with focus on lupus nephritis. Front Med (Lausanne). 2021; 8:654912. | eng |
| dcterms.references | Santacruz JC, Pulido S, Arzuaga A, et al. Current evidence for IL17/23 blockade for the treatment of lupus nephritis. Cureus. 2021; 13:e20087. | eng |
| dcterms.references | Novartis Pharmaceuticals Corporation. Cosentyx (secukinumab) [package insert]. U.S. Food and Drug Administration website. Revised October 2024. https://www.accessdata.fda.gov/drugsatfda_ docs/label/2024/125504Orig1s080,%20761349Orig1s005lbl.pdf. (26 December 2024, date last accessed). | eng |
| dcterms.references | Sun R, Bustamante M, Gurusamy VK et al. Safety of secukinumab from 1 million patient-years of exposure: experience from postmarketing setting and clinical trials. Dermatol Ther (Heidelb) 2024;14:729–43. | eng |
| dcterms.references | Costa R, Antunes P, Salvador P et al. Secukinumab on refractory lupus nephritis. Cureus 2021;13:e17198. | eng |
| dcterms.references | Satoh Y, Nakano K, Yoshinari H et al. A case of refractory lupus nephritis complicated by psoriasis vulgaris that was controlled with secukinumab. Lupus 2018;27:1202–6. | eng |
| dcterms.references | Davidson JE, Fu Q, Ji B et al. Renal remission status and long term renal survival in patients with lupus nephritis: a retrospective cohort analysis. J Rheumatol 2018;45:671–7. | eng |
| dcterms.references | Sprangers B, Monahan M, Appel GB. Diagnosis and treatment of lupus nephritis flares—an update. Nat Revi Nephrol 2012; 8:709–17. | eng |
| dcterms.references | Wong CY, Ma BM, Zhang D, et al. Cardiovascular risk factors and complications in patients with systemic lupus erythematosus with and without nephritis: a systematic review and meta-analysis. Lupus Sci Med. 2024;11:e001152. | eng |
| dcterms.references | Thakare SB, So PN, Rodriguez S, GlomCon Editorial Team et al. Novel therapeutics for management of lupus nephritis: what is next? Kidney Med 2023;5:100688. | eng |
| dcterms.references | Rovin B, Furie R, Garg J et al. WCN25-3676 results from the regency trial assessing efficacy and safety of obinutuzumab in active lupus nephritis. Kidney Int Rep 2025;10:S771–S772. | eng |
| dcterms.references | Hruskova Z, Tesar V. Lessons learned from the failure of several recent trials with biologic treatment in systemic lupus erythematosus. Expert Opin Biol Ther. 2018;18:989–96. | eng |
| dcterms.references | Rovin BH, Furie R, Latinis K; LUNAR Investigator Group et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum 2012;64:1215–26. | eng |
| oaire.version | info:eu-repo/semantics/publishedVersion | |
| sb.sede | Sede Barranquilla | spa |