Anifrolumab in systemic lupus erythematosus: real-world evidence from a Spanish multicentre cohort of 206 patients and literature review
Por:
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
Publicada:
1 mar 2026
Resumen:
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.
Filiaciones:
Calvo-Río, V:
Univ Cantabria, Hosp Univ Marques Valdecilla, IDIVAL,Immunopathol Grp, Div Rheumatol,Rheumatol,Dept Med & Psychiat, Santander, Spain
Secada-Gómez, C:
Univ Cantabria, Hosp Univ Marques Valdecilla, IDIVAL,Immunopathol Grp, Div Rheumatol,Rheumatol,Dept Med & Psychiat, Santander, Spain
Gutiérrez, AM:
Univ Cantabria, Hosp Univ Marques Valdecilla, IDIVAL,Immunopathol Grp, Div Rheumatol,Rheumatol,Dept Med & Psychiat, Santander, Spain
Retuerto-Guerrero, M:
Hosp Univ Leon, Rheumatol, Leon, Spain
Font, J:
Hosp Univ Germans Trias i Pujol, Rheumatol, Barcelona, Spain
Casafont-Solé, I:
Hosp Univ Germans Trias i Pujol, Rheumatol, Barcelona, Spain
Mayo-Juanatey, A:
Hosp Univ Doctor Peset, Rheumatol, Valencia, Spain
Sancho, JJA:
Hosp Univ Doctor Peset, Rheumatol, Valencia, Spain
Freites, D:
Hosp Clin Univ San Carlos, Rheumatol, Madrid, Spain
Hormigos, C:
Hosp Clin Univ San Carlos, Rheumatol, Madrid, Spain
Puñal, NG:
Hosp Quironsalud Infanta Luisa, Rheumatol, Seville, Spain
Arribas, GG:
Hosp Univ A Coruna, Rheumatol, La Coruna, Spain
Sanchez, JRM:
Hosp Univ Mostoles, Rheumatol, Madrid, Spain
García-Valle, A:
Hosp Gen Rio Carrion, Rheumatol, Palencia, Spain
Ibañez, M:
Hosp Clin Univ Salamanca, Rheumatol, Salamanca, Spain
Morillo, FL:
Hosp Cent Def Gomez Ulla, Rheumatol, Madrid, Spain
Manzanares, AG:
Hosp Univ Torrevieja, Rheumatol, Alicante, Spain
Sandoval-Moreno, S:
Hosp Univ Vall dHebron, Rheumatol, Barcelona, Spain
Cortes-Hernandez, J:
Hosp Univ Vall dHebron, Rheumatol, Barcelona, Spain
Sanchez, DP:
Hosp Rafael Mendez, Rheumatol, Murcia, Spain
Lojo, L:
Hosp Univ Infanta Leonor, Rheumatol, Madrid, Spain
Pérez, ECC:
Hosp Prov Pontevedra, Rheumatol, Pontevedra, Spain
Collado, P:
Hosp Univ Severo Ochoa, Rheumatol, Madrid, Spain
Larios, CA:
Hosp Merida, Rheumatol, Badajoz, Spain
Icardo, LS:
Hosp Univ Torrejon, Rheumatol, Madrid, Spain
Labrador-Sánchez, E:
Hosp Gen La Rioja, Rheumatol, Logrono, Spain
Peralta-Ginés, C:
Hosp Clin Univ Lozano Blesa, Rheumatol, Zaragoza, Spain
Onaindia, IU:
Hosp Galdakao, Rheumatol, Vizcaya, Spain
Plaza-Aulestia, N:
Hosp Galdakao, Rheumatol, Vizcaya, Spain
Malone, MM:
Hosp Calahorra, Rheumatol, Calahorra, Spain
de Salazar, JRG:
Hosp Marina Baixa, Rheumatol, Villajoyosa, Spain
Corteguera, M:
Complejo Asistencial Avila, Rheumatol, Avila, Spain
Cebrián-Méndez, L:
Hosp Univ Infanta Leonor, Rheumatol, Madrid, Spain
Pages, FAA:
Hosp Gen Segovia, Rheumatol, Segovia, Spain
Riazuelo, JRL:
Hosp Univ Henares, Rheumatol, Madrid, Spain
Canales, MDF:
Hosp Barbastro, Rheumatol, Huesca, Spain
Hernández, MJA:
Hosp Univ Puerta Mar, Rheumatol, Cadiz, Spain
Bufort, MG:
Hosp Sagunto, Rheumatol, Valencia, Spain
Pàmies, A:
Hosp Verge Cinta, Rheumatol, Tortosa, Spain
de Ardanaz, LS:
Complejo Hosp Jaen, Rheumatol, Jaen, Spain
Aguirre-del-Pino, R:
Hosp Univ Lucus Augusti, Rheumatol, Lugo, Spain
Lefler, JAC:
Complejo Asistencial Zamora, Rheumatol, Zamora, Spain
Seijas-Lopez, A:
Hosp Univ Lucus Augusti, Rheumatol, Lugo, Spain
Cubero, MDC:
Complejo Hosp Univ Badajoz, Rheumatol, Badajoz, Spain
Cofiño, ALC:
Hosp Santa Barbara, Rheumatol, Soria, Spain
Ortiz-Santamaria, V:
Hosp Gen Granollers, Rheumatol, Barcelona, Spain
Piñeiro, ML:
Hosp Univ Navarra, Rheumatol, Pamplona, Spain
Calvo, CO:
Hosp Univ Cabuenes, Rheumatol, Gijon, Spain
Lopez, CA:
Hosp Univ Infanta Elena, Rheumatol, Madrid, Spain
Urruticoechea-Arana, A:
Hosp Univ Son Espases, Rheumatol, Illes Balears, Spain
Magallon, BG:
Hosp Univ Puerta Hierro, Rheumatol, Madrid, Spain
Alfaro, AVA:
Hosp Univ Infanta Sofia, Rheumatol, Madrid, Spain
Rodriguez, SL:
Hosp Univ La Fe, Rheumatol, Valencia, Spain
Olivares, MS:
Hosp Infanta Cristina, Rheumatol, Madrid, Spain
Villar, PL:
Hosp Gen Villalba, Rheumatol, Madrid, Spain
Brandy-García, AM:
Hosp Univ Cabuenes, Rheumatol, Gijon, Spain
Vilamajo, IR:
Hosp Son Llatzer, Rheumatol, Manacor, Spain
Martos, AG:
Hosp Tajo, Rheumatol, Madrid, Spain
Lopez, BPM:
Hosp Santa Creu & Sant Pau, Rheumatol, Barcelona, Spain
Urmeneta, GS:
Hosp Reina Sofia, Rheumatol, Navarra, Spain
Martín, CC:
Hosp Univ Nuestra Senora Candelaria, Rheumatol, Canarias, Spain
Riera, E:
Hosp Univ Mutua Terrassa, Rheumatol, Barcelona, Spain
Bejerano, C:
Univ Cantabria, Hosp Univ Marques Valdecilla, IDIVAL,Immunopathol Grp, Div Rheumatol,Rheumatol,Dept Med & Psychiat, Santander, Spain
Castañeda, S:
Hosp Univ Princesa, IIS Princesa, Rheumatol, Madrid, Spain
Blanco, R:
Univ Cantabria, Hosp Univ Marques Valdecilla, IDIVAL,Immunopathol Grp, Div Rheumatol,Rheumatol,Dept Med & Psychiat, Santander, Spain
Green Submitted, gold
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