Anifrolumab in systemic lupus erythematosus: real-world evidence from a Spanish multicentre cohort of 206 patients and literature review.

BACKGROUND: Anifrolumab is approved for adults with moderate-to-severe active systemic lupus erythematosus (SLE) based on Randomised clinical trials (RCTs). While randomised pivotal RCTs have demonstrated their efficacy and safety, real-world evidence (RWE) remains limited. OBJECTIVES: To describe t...

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Autores: Calvo-Río V, Secada-Gómez C, Martín Gutiérrez A, Retuerto-Guerrero M, Font J, Casafont-Solé I, Mayo-Juanatey A, Alegre Sancho JJ, Freites D, Hormigos C, Garrido Puñal N, González Arribas G, Miguélez Sanchez JR, García-Valle A, Ibañez M, Lozano Morillo F, García Manzanares Á, Sandoval-Moreno S, Cortes-Hernandez J, Palma Sanchez D, Lojo L, Cervantes Pérez EC, Collado P, Arciniega Larios C, Sala Icardo L, Labrador-Sánchez E, Peralta-Ginés C, Urionagüena Onaindia I, Plaza-Aulestia N, Medina Malone M, Gómez de Salazar JR, Corteguera M, Cebrián-Méndez L, Antón Pages FA, Lamua Riazuelo JR, Fábregas Canales MD, Alados Hernández MJ, Garijo Bufort M, Pàmies A, Sarabia de Ardanaz L, Aguirre-Del-Pino R, Cabezas Lefler JÁ, Seijas-Lopez Á, Carrasco Cubero MDC, López-Cerón Cofiño A, Ortiz-Santamaria V, Laiño Piñeiro M, Ordás Calvo C, Arconada Lopez C, Urruticoechea-Arana A, Garcia Magallon B, Acosta Alfaro AV, Leal Rodriguez S, Salido Olivares M, Lavilla Villar P, Brandy-García AM, Ros Vilamajo I, García Martos Á, Magallares Lopez BP, Sada Urmeneta G, Córdoba Martín C, Riera E, Bejerano C, Castañeda S, Blanco R
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2026
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:dnet:r-fisabio___::7a5645cf8cac4b44596f1ffeee4f3bba
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/20756
Access Level:acceso abierto
Palabra clave:autoimmune diseases
biological therapy
lupus erythematosus, systemic
Descripción
Sumario:BACKGROUND: Anifrolumab is approved for adults with moderate-to-severe active systemic lupus erythematosus (SLE) based on Randomised clinical trials (RCTs). While randomised pivotal RCTs have demonstrated their efficacy and safety, real-world evidence (RWE) remains limited. OBJECTIVES: To describe the clinical characteristics, effectiveness and safety of anifrolumab in clinical practice and to assess findings from published observational studies. METHODS: Multicentre study of patients with SLE classified according to EULAR/American College of Rheumatology (ACR) 2019. Data were collected from medical records up to 30 April 2025. Variables included demographic characteristics, clinical and serological features, prior and concomitant therapies, disease activity indices including the SLE Disease Activity Index 2000 (SLEDAI-2K), SLE Disease Activity Score (SLE-DAS) and Physician Global Assessment (PGA), damage and disease control measures including the Systemic Lupus International Collaborating Clinics/ACR Damage Index, Lupus Low Disease Activity State (LLDAS) and Definitions of Remission in SLE (DORIS) remission and the association with adverse events (AEs). A review of published observational studies was also conducted. RESULTS: We included 206 patients (183 women; mean age 44.6±12.6 years) from 54 Spanish centres. The most common indications for anifrolumab were cutaneous (61.7%), musculoskeletal (48.5%) and haematological (27.2%).A rapid and sustained improvement was observed in disease activity (SLEDAI-2K, SLE-DAS, PGA), LLDAS, DORIS remission, serological markers (anti-double-stranded DNA, C3/C4) and corticosteroid tapering. Organ damage remained stable. After a mean follow-up of 7.5±5.3 months, the most frequent AEs were herpes zoster (n=?5), respiratory infections (n=?6) and headache (n=?3). Twenty patients discontinued treatment. These results were consistent with published observational studies. CONCLUSION: In this large RWE cohort, anifrolumab demonstrated early and sustained clinical benefit, a favourable safety profile and a significant corticosteroid-sparing effect. These findings reinforce the evidence from CT and support the incorporation of anifrolumab into routine care for patients with SLE.

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