{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Rheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain"
      ],
      "name": "Vanesa Calvo-Río"
    },
    {
      "affiliations": [
        "Rheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain"
      ],
      "name": "Carmen Secada-Gómez"
    },
    {
      "affiliations": [
        "Rheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain"
      ],
      "name": "Adrián Martín-Gutiérrez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de León, León, Spain"
      ],
      "name": "Miriam Retuerto-Guerrero"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain"
      ],
      "name": "Judit Font"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain"
      ],
      "name": "Ivette Casafont-Solé"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Doctor Peset, Valencia, Spain"
      ],
      "name": "Adrián Mayo-Juanatey"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Doctor Peset, Valencia, Spain"
      ],
      "name": "Juan José Alegre Sancho"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Clínico Universitario San Carlos, Madrid, Spain"
      ],
      "name": "Dalifer Freites"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Clínico Universitario San Carlos, Madrid, Spain"
      ],
      "name": "Cristina Hormigos"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Quirónsalud Infanta Luisa, Sevilla, Spain"
      ],
      "name": "Noemi Garrido Puñal"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de A Coruña, A Coruña, Spain"
      ],
      "name": "Guillermo González Arribas"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de Móstoles, Madrid, Spain"
      ],
      "name": "Juan Roberto Miguélez Sanchez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital General Río Carrión, Palencia, Spain"
      ],
      "name": "Andrea García-Valle"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Clínico Universitario de Salamanca, Salamanca, Spain"
      ],
      "name": "Marta Ibañez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Central de La Defensa Gómez Ulla, Madrid, Spain"
      ],
      "name": "Fernando Lozano Morillo"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain"
      ],
      "name": "Ángel García Manzanares"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Vall d′Hebrón, Barcelona, Spain"
      ],
      "name": "Sebastián Sandoval-Moreno"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Vall d′Hebrón, Barcelona, Spain"
      ],
      "name": "Josefina Cortes-Hernandez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Rafael Méndez, Murcia, Spain"
      ],
      "name": "Deseada Palma Sanchez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Infanta Leonor, Madrid, Spain"
      ],
      "name": "Leticia Lojo"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Provincial de Pontevedra, Pontevedra, Spain"
      ],
      "name": "Evelin Cecilia Cervantes Pérez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Severo Ochoa, Madrid, Spain"
      ],
      "name": "Paz Collado"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital de Mérida, Badajoz, Spain"
      ],
      "name": "Cristina Arciniega Larios"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de Torrejón, Madrid, Spain"
      ],
      "name": "Luis Sala Icardo"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital General de La Rioja, Logroño, Spain"
      ],
      "name": "Eztizen Labrador-Sánchez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain"
      ],
      "name": "Cilia Peralta-Ginés"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Galdakao, Vizcaya, Spain"
      ],
      "name": "Irati Urionagüena Onaindia"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Galdakao, Vizcaya, Spain"
      ],
      "name": "Nahia Plaza-Aulestia"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital de Calahorra, Calahorra, Spain"
      ],
      "name": "Miguel Medina Malone"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Marina Baixa, Villajoyosa, Spain"
      ],
      "name": "José Rosas Gómez de Salazar"
    },
    {
      "affiliations": [
        "Rheumatology, Complejo Asistencial de Ávila, Ávila, Spain"
      ],
      "name": "Montserrat Corteguera"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Infanta Leonor, Madrid, Spain"
      ],
      "name": "Laura Cebrián-Méndez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital General de Segovia, Segovia, Spain"
      ],
      "name": "Fred Antonio Antón Pages"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario del Henares, Madrid, Spain"
      ],
      "name": "José Ramón Lamua Riazuelo"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital de Barbastro, Huesca, Spain"
      ],
      "name": "María Dolores Fábregas Canales"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Puerta del Mar, Cádiz, Spain"
      ],
      "name": "María José Alados Hernández"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital de Sagunto, Valencia, Spain"
      ],
      "name": "Marta Garijo Bufort"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Verge de la Cinta, Tortosa, Spain"
      ],
      "name": "Anna Pàmies"
    },
    {
      "affiliations": [
        "Rheumatology, Complejo Hospitalario de Jaén, Jaén, Spain"
      ],
      "name": "Luis Sarabia de Ardanaz"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain"
      ],
      "name": "Rodrigo Aguirre-del-Pino"
    },
    {
      "affiliations": [
        "Rheumatology, Complejo Asistencial de Zamora, Zamora, Spain"
      ],
      "name": "José Ángel Cabezas Lefler"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain"
      ],
      "name": "Álvaro Seijas-Lopez"
    },
    {
      "affiliations": [
        "Rheumatology, Complejo Hospitalario Universitario de Badajoz, Badajoz, Spain"
      ],
      "name": "María del Carmen Carrasco Cubero"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Santa Bárbara, Soria, Spain"
      ],
      "name": "Ana López-Cerón Cofiño"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital General de Granollers, Barcelona, Spain"
      ],
      "name": "Vera Ortiz-Santamaria"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de Navarra, Pamplona, Spain"
      ],
      "name": "María Laiño Piñeiro"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de Cabueñes, Gijón, Spain"
      ],
      "name": "Carmen Ordás Calvo"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Infanta Elena, Madrid, Spain"
      ],
      "name": "Celia Arconada Lopez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Son Espases, Illes Balears, Spain"
      ],
      "name": "Ana Urruticoechea-Arana"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Puerta de Hierro, Madrid, Spain"
      ],
      "name": "Blanca Garcia Magallon"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Infanta Sofía, Madrid, Spain"
      ],
      "name": "Ana Valeria Acosta Alfaro"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario La Fe, Valencia, Spain"
      ],
      "name": "Samuel Leal Rodriguez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Infanta Cristina, Madrid, Spain"
      ],
      "name": "Marina Salido Olivares"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital General de Villalba, Madrid, Spain"
      ],
      "name": "Patricia Lavilla Villar"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de Cabueñes, Gijón, Spain"
      ],
      "name": "Anahy M Brandy-García"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Son Llàtzer, Manacor, Spain"
      ],
      "name": "Inmaculada Ros Vilamajo"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital del Tajo, Madrid, Spain"
      ],
      "name": "Álvaro García Martos"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain"
      ],
      "name": "Berta Paula Magallares Lopez"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Reina Sofía, Navarra, Spain"
      ],
      "name": "Guillén Sada Urmeneta"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Nuestra Señora de la Candelaria, Canarias, Spain"
      ],
      "name": "Cristina Córdoba Martín"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Mútua Terrassa, Barcelona, Spain"
      ],
      "name": "Elena Riera"
    },
    {
      "affiliations": [
        "Rheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain"
      ],
      "name": "Carmen Bejerano"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid, Spain"
      ],
      "name": "Santos Castañeda"
    },
    {
      "affiliations": [
        "Rheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain"
      ],
      "name": "Ricardo Blanco"
    }
  ],
  "title": "Anifrolumab in systemic lupus erythematosus: real-world evidence from a Spanish multicentre cohort of 206 patients and literature review",
  "uid": "af80b17a-3927-57c0-bbf4-9d6b4caf9ccc"
}