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 the...

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Autores: Calvo-Río, V, Secada-Gómez, C, Gutiérrez, AM, Retuerto-Guerrero, M, Font, J, Casafont-Solé, I, Mayo-Juanatey, A, Sancho, JJA, Freites, D, Hormigos, C, Puñal, NG, Arribas, GG, Sanchez, JRM, García-Valle, A, Ibañez, M, Morillo, FL, Manzanares, AG, Sandoval-Moreno, S, Cortes-Hernandez, J, Sanchez, DP, Lojo, L, Pérez, ECC, Collado, P, Larios, CA, Icardo, LS, Labrador-Sánchez, E, Peralta-Ginés, C, Onaindia, IU, Plaza-Aulestia, N, Malone, MM, de Salazar, JRG, Corteguera, M, Cebrián-Méndez, L, Pages, FAA, Riazuelo, JRL, Canales, MDF, Hernández, MJA, Bufort, MG, Pàmies, A, de Ardanaz, LS, Aguirre-del-Pino, R, Lefler, JAC, Seijas-Lopez, A, Cubero, MDC, Cofiño, ALC, Ortiz-Santamaria, V, Piñeiro, ML, Calvo, CO, Lopez, CA, Urruticoechea-Arana, A, Magallon, BG, Alfaro, AVA, Rodriguez, SL, Olivares, MS, Villar, PL, Brandy-García, AM, Vilamajo, IR, Martos, AG, Lopez, BPM, Urmeneta, GS, Martín, CC, Riera, E, Bejerano, C, Castañeda, S, Blanco, R
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2026
País:España
Institución:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:dnet:r-iibsantpa_::499d488905541282caf2ab28a095360b
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=21532
Access Level:acceso abierto
Palabra clave:lupus erythematosus, systemic
biological therapy
autoimmune diseases
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.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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