Secukinumab in active lupus nephritis: results from a phase III randomized, placebo-controlled study (SELUNE) and an open-label extension study

Hui Zhao, Ming; Cons Molina, Fidencio; Aroca, Gustavo; Tektonidou, Maria G.; Mathur, Anubhav; Tangadpalli, Radhika; Sun, Rui; Martin, Ruvie; Pellet, Pascale; Phuong Huynh, Thao Ngoc

Secukinumab in active lupus nephritis: results from a phase III randomized, placebo-controlled study (SELUNE) and an open-label extension study

Archivos

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Fecha

2026

Autores

Hui Zhao, Ming

Cons Molina, Fidencio

Aroca, Gustavo

Tektonidou, Maria G.

Mathur, Anubhav

Tangadpalli, Radhika

Sun, Rui

Martin, Ruvie

Pellet, Pascale

Phuong Huynh, Thao Ngoc

Editor

Oxford University Press
British Society for Rheumatology

Resumen

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.

Citación

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