Evidence map›Paper›PMID 41856562›Full record

ReviewRMD open2026

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

Vanesa Calvo-Río, Carmen Secada-Gómez, Adrián Martín-Gutiérrez, Miriam Retuerto-Guerrero, Judit Font, Ivette Casafont-Solé, Adrián Mayo-Juanatey, Juan José Alegre Sancho, Dalifer Freites, Cristina Hormigos and 55 more

Abstract readMulticenter StudyReview
In one paragraph

Review in RMD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

65 authors.

Vanesa Calvo-RíoRheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain fiorelfa@hotmail.com.ORCID 0000-0002-9654-0698
Carmen Secada-GómezRheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain.
Adrián Martín-GutiérrezRheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain.
Miriam Retuerto-GuerreroRheumatology, Hospital Universitario de León, León, Spain.ORCID 0000-0003-0248-657X
Judit FontRheumatology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
Ivette Casafont-SoléRheumatology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
Adrián Mayo-JuanateyRheumatology, Hospital Universitario Doctor Peset, Valencia, Spain.ORCID 0009-0008-5434-3021
Juan José Alegre SanchoRheumatology, Hospital Universitario Doctor Peset, Valencia, Spain.
Dalifer FreitesRheumatology, Hospital Clínico Universitario San Carlos, Madrid, Spain.
Cristina HormigosRheumatology, Hospital Clínico Universitario San Carlos, Madrid, Spain.
Noemi Garrido PuñalRheumatology, Hospital Quirónsalud Infanta Luisa, Sevilla, Spain.
Guillermo González ArribasRheumatology, Hospital Universitario de A Coruña, A Coruña, Spain.
Juan Roberto Miguélez SanchezRheumatology, Hospital Universitario de Móstoles, Madrid, Spain.
Andrea García-ValleRheumatology, Hospital General Río Carrión, Palencia, Spain.
Marta IbañezRheumatology, Hospital Clínico Universitario de Salamanca, Salamanca, Spain.
Fernando Lozano MorilloRheumatology, Hospital Central de La Defensa Gómez Ulla, Madrid, Spain.
Ángel García ManzanaresRheumatology, Hospital Universitario de Torrevieja, Alicante, Spain.
Sebastián Sandoval-MorenoRheumatology, Hospital Universitario Vall d'Hebrón, Barcelona, Spain.
Josefina Cortes-HernandezRheumatology, Hospital Universitario Vall d'Hebrón, Barcelona, Spain.
Deseada Palma SanchezRheumatology, Hospital Rafael Méndez, Murcia, Spain.
Leticia LojoRheumatology, Hospital Universitario Infanta Leonor, Madrid, Spain.
Evelin Cecilia Cervantes PérezRheumatology, Hospital Provincial de Pontevedra, Pontevedra, Spain.
Paz ColladoRheumatology, Hospital Universitario Severo Ochoa, Madrid, Spain.
Cristina Arciniega LariosRheumatology, Hospital de Mérida, Badajoz, Spain.
Luis Sala IcardoRheumatology, Hospital Universitario de Torrejón, Madrid, Spain.
Eztizen Labrador-SánchezRheumatology, Hospital General de La Rioja, Logroño, Spain.
Cilia Peralta-GinésRheumatology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
Irati Urionagüena OnaindiaRheumatology, Hospital Galdakao, Vizcaya, Spain.
Nahia Plaza-AulestiaRheumatology, Hospital Galdakao, Vizcaya, Spain.
Miguel Medina MaloneRheumatology, Hospital de Calahorra, Calahorra, Spain.
José Rosas Gómez de SalazarRheumatology, Hospital Marina Baixa, Villajoyosa, Spain.
Montserrat CortegueraRheumatology, Complejo Asistencial de Ávila, Ávila, Spain.
Laura Cebrián-MéndezRheumatology, Hospital Universitario Infanta Leonor, Madrid, Spain.
Fred Antonio Antón PagesRheumatology, Hospital General de Segovia, Segovia, Spain.
José Ramón Lamua RiazueloRheumatology, Hospital Universitario del Henares, Madrid, Spain.
María Dolores Fábregas CanalesRheumatology, Hospital de Barbastro, Huesca, Spain.
María José Alados HernándezRheumatology, Hospital Universitario Puerta del Mar, Cádiz, Spain.
Marta Garijo BufortRheumatology, Hospital de Sagunto, Valencia, Spain.
Anna PàmiesRheumatology, Hospital Verge de la Cinta, Tortosa, Spain.
Luis Sarabia de ArdanazRheumatology, Complejo Hospitalario de Jaén, Jaén, Spain.
Rodrigo Aguirre-Del-PinoRheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain.
José Ángel Cabezas LeflerRheumatology, Complejo Asistencial de Zamora, Zamora, Spain.
Álvaro Seijas-LopezRheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain.
María Del Carmen Carrasco CuberoRheumatology, Complejo Hospitalario Universitario de Badajoz, Badajoz, Spain.
Ana López-Cerón CofiñoRheumatology, Hospital Santa Bárbara, Soria, Spain.
Vera Ortiz-SantamariaRheumatology, Hospital General de Granollers, Barcelona, Spain.
María Laiño PiñeiroRheumatology, Hospital Universitario de Navarra, Pamplona, Spain.
Carmen Ordás CalvoRheumatology, Hospital Universitario de Cabueñes, Gijón, Spain.
Celia Arconada LopezRheumatology, Hospital Universitario Infanta Elena, Madrid, Spain.
Ana Urruticoechea-AranaRheumatology, Hospital Universitario Son Espases, Illes Balears, Spain.
Blanca Garcia MagallonRheumatology, Hospital Universitario Puerta de Hierro, Madrid, Spain.ORCID 0000-0002-5835-7171
Ana Valeria Acosta AlfaroRheumatology, Hospital Universitario Infanta Sofía, Madrid, Spain.
Samuel Leal RodriguezRheumatology, Hospital Universitario La Fe, Valencia, Spain.
Marina Salido OlivaresRheumatology, Hospital Infanta Cristina, Madrid, Spain.
Patricia Lavilla VillarRheumatology, Hospital General de Villalba, Madrid, Spain.
Anahy M Brandy-GarcíaRheumatology, Hospital Universitario de Cabueñes, Gijón, Spain.
Inmaculada Ros VilamajoRheumatology, Hospital Son Llàtzer, Manacor, Spain.
Álvaro García MartosRheumatology, Hospital del Tajo, Madrid, Spain.
Berta Paula Magallares LopezRheumatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain.
Guillén Sada UrmenetaRheumatology, Hospital Reina Sofía, Navarra, Spain.
Cristina Córdoba MartínRheumatology, Hospital Universitario Nuestra Señora de la Candelaria, Canarias, Spain.
Elena RieraRheumatology, Hospital Universitario Mútua Terrassa, Barcelona, Spain.
Carmen BejeranoRheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain.
Santos CastañedaRheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid, Spain.ORCID 0000-0002-7748-853X
Ricardo BlancoRheumatology, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Department of Medicine and Psychiatry, University of Cantabria, Santander, Spain.ORCID 0000-0003-2344-2285

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnifrolumab 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.

objectivesTo describe the clinical characteristics, effectiveness and safety of anifrolumab in clinical practice and to assess findings from published observational studies.

methodsMulticentre 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.

resultsWe 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.

conclusionIn 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.

Indexed as

Antibodies, Monoclonal, HumanizedLupus Erythematosus, SystemicAdultFemaleHumansMaleMiddle AgedSeverity of Illness IndexSpainTreatment OutcomeanifrolumabAntibodies, Monoclonal, Humanizedautoimmune diseasesbiological therapylupus erythematosus, systemic

Identifiers

PMID41856562
PMCPMC13007143

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