Anifrolumab In Systemic Lupus Erythematosus. Spanish Multicenter Registry In Clinical Practice

Vanesa Calvo-Río¹, Carmen Secada-Gómez¹, Miriam Retuerto Guerrero², Judit Font-Urgelles³, Ivette Casafont-Solé³, Adrián Mayo-Juanatey⁴, Juan José Alegre-Sancho⁵, DALIFER FREITES⁶, Cristina Hormigos Martin⁷, Noemí Garrido⁸, GUILLERMO GONZALEZ ARRIBAS⁹, Juan Roberto Miguelez Sanchez¹⁰, Andrea García-Valle¹¹, Marta Ibañez¹², Fernando Lozano Morillo¹³, Ángel García Manzanares¹⁴, Sebastián Sandoval-Moreno¹⁵, Josefina Cortés-Hernández¹⁶, Deseada Palma-Sanchez¹⁷, LETICIA LOJO-OLIVEIRA¹⁸, Evelin Cervantes¹⁹, Paz Collado Ramos²⁰, cristina arciniega Larios²¹, Luis Sala²², Eztizen Labrador-Sánchez²³, Cilia Peralta-Ginés²⁴, Nahia Plaza-Aulestia²⁵, Irati Urionaguena Onaindia²⁶, Miguel Medina Malone²⁷, Jose Rosas Gómez de Salazar²⁸, Montserrat Corteguera²⁹, Laura Cebrian³⁰, Fred Anton Pages³¹, Jose Ramón Lamua-Riazuelo³², María Dolores Fábregas Canales³³, María José Alados Hernández³⁴, Marta Garijo Bufort³⁵, Anna Pamies³⁶, Luis Sarabia³⁷, Rodrigo Aguirre-del-Pino³⁸, José Ángel Cabezas Lefler³⁹, alvaro seijas³⁸, Carmen Carrasco-Cubero⁴⁰, Ana López-Cerón Cofiño⁴¹, Vera Ortiz-Santamaria⁴², Santos Castañeda⁴³, Maria Laino⁴⁴, Carmen Ordás Calvo⁴⁵, Celia arconada⁴⁶ and ana Urruticoechea-Arana⁴⁷, ¹Rheumatology Division, Hospital Universitario Marqués de Valdecilla, IDIVAL, Immunopathology Group, Santander, Spain, Santander, Cantabria, Spain, ²Complejo Asistencial Universitario de León, Leon, Castilla y Leon, Spain, ³Hospital Universitari Germans Trias i Pujol, Badalona, Spain, ⁴Hospital Universitario Doctor Peset, Valencia, Comunidad Valenciana, Spain, ⁵Hospital Universitario Doctor Peset, Valencia, Spain, ⁶Rheumatology Service, San Carlos Clinical Hospital, Madrid, Madrid, Spain, ⁷Hospital Clínico San Carlos, Madrid, Spain, ⁸Hospital Universitario Virgen del Rocío, Sevilla, Andalucia, Spain, ⁹Facultativo especialista, PALMA DE MALLORCA, Galicia, Spain, ¹⁰Department of Rheumatology, Hospital Universtiario de Móstoles, Madrid, Spain, Madrid, Madrid, Spain, ¹¹Rheumatology. Hospital General Río Carrión, Palencia, Castilla y Leon, Spain, ¹²Hospital Universitario de la Santa Creu i Sant Pau, Barcelona, Catalonia, Spain, ¹³Hospital Central de La Defensa Gómez Ulla, Madrid, Madrid, Spain, ¹⁴Hospital Universitario de Torrevieja, Alicante, Spain, ¹⁵Hospital Universitario Vall D'Hebron, Barcelona, Spain, ¹⁶Hospital Universitari Vall d’Hebron-Universitat Autónoma de Barcelona, Barcelona, Spain, ¹⁷Rheumatology. Hospital Rafael Méndez, Lorca, Murcia, Spain, ¹⁸Hospital Universitario Infanta Leonor, Madrid, Spain, ¹⁹Hospital Provincial de Pontevedra, Pontevedra, Spain, ²⁰Department of Rheumatology, Hospital Universitario Severo Ochoa, Madrid, Spain,, MADRID, Madrid, Spain, ²¹Hospital de Mérida, Badajoz, Spain, ²²Hospital Universitario de Torrejón, Madrid, Spain, ²³Hospital General de La Rioja, Logroño, Spain, ²⁴Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain, ²⁵Hospital Galdakao, Vizcaya, Spain, ²⁶Rheumatology.Hospital Galdakao, Vizcaya, Pais Vasco, Spain, ²⁷Hospital de Calahorra, Gorríiz, Spain, ²⁸Hospital Marina Baixa, PALMA DE MALLORCA, Spain, ²⁹Rheumatology. Complejo Asistencial de Ávila, Ávila, Castilla y Leon, Spain, ³⁰Department of Rheumatology, Hospital Universitario Infanta Leonor / Universidad Complutense de Madrid, Madrid, Spain, Madrid, Spain, ³¹Hospital General de Segovia, Segovia, Spain, ³²Hospital Universitario del Henares, Madrid, Spain, ³³Hospital de Barbastro, Huesca, Spain, ³⁴Hospital Universitario Puerta del Mar, Cadiz, Spain, ³⁵Hospital de Sagunto, Valencia, Spain, ³⁶Hospital Verge de la Cinta, Tortosa, Tarragona, Spain, ³⁷Complejo Hospitalario de Jaén, Jaén, Spain, ³⁸Hospital Universitario Lucus Augusti, Lugo, Spain, ³⁹Complejo Asistencial de Zamora, Zamora, Spain, ⁴⁰Complejo Hospitalario Universitario de Badajoz, Badajoz, Spain, ⁴¹Hospital Santa Bárbara, Soria, Spain, ⁴²Hospital General de Granollers, Barcelona, Spain, ⁴³Hospital Universitario de La Princesa, IIS-Princesa, Madrid, Madrid, Spain, ⁴⁴Hospital Universitario de Navarra, Pamplona, Spain, ⁴⁵Hospital Universitario de Cabueñes, Gijón, Spain, ⁴⁶Hospital universitario de Getafe, Getafe, Madrid, Spain, ⁴⁷Rheumatology Division. Hospital Universitario Son Espases, Palma de Mallorca, Spain

Meeting: ACR Convergence 2025

Keywords: Biologicals, Systemic lupus erythematosus (SLE)

Session Information

Date: Monday, October 27, 2025

Title: (1517–1552) Systemic Lupus Erythematosus – Treatment Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: Anifrolumab (ANI) is a human monoclonal antibody that binds to the type I interferon receptor subunit 1 (IFNAR1). ANI was approved by Spanish authorities for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) with positive autoantibodies, in combination with standard treatment.In patients with SLE treated with ANI in clinical practice in Spain, our aim was to assess a) the profile of patients receiving ANI b) effectiveness and c) safety.

Methods: Observational multicenter study of patients diagnosed with SLE (EULAR/ACR 2019 classification criteria) treated with ANI. Data were collected from medical records up to April 31st 2025. Demographic, clinical, laboratory, and pathologic variables were evaluated, along with previous and concomitant therapies, disease activity indices (SLE-DAS, SLEDAI-2K, PGA), organ damage index (SDI), and safety were evaluated.

Results: 206 patients (183 females/23 males), mean age 44.6 ± 12.6 years (range 15-90 years) (54 hospitals) were included. Baseline characteristics of patients and prior treatment before starting ANI are summarized in TABLE.The main reason for starting ANI was clinical activity: cutaneous (n=124, 61.7%), articular (n=98, 48.5%), hematological (n=55, 27.2%), corticosteroid dependence (n=11, 5.4%), renal (n=8, 4%), serositis (n=6, 3%), serious adverse events with other immunosuppressants (n=4, 1.9%), neurological (n=2, 1%), and Kikuchi disease (n=1, 0.5%).The mean number of immunosuppressants (synthetic/biologic) received prior to ANI was 2.5±1.6 (range 0-8). All patients received 300 mg/4 weeks of ANI except two patients with renal involvement who received a loading dose (900 mg/4 weeks x3 months followed by 300 mg/4 weeks). In addition to corticosteroids and antimalarials, ANI was administered in many cases concomitantly with other immunomodulator drug (TABLE).A rapid (from the 1st month) and maintained significant improvement was observed in: a) disease activity (SLE-DAS, SLEDAI-2K, PGA) (Figure 1) b) immunologic markers (decrease in anti-dsDNA antibody titers and normalization of C3 and C4 levels) (Figure 1) and c) prednisone dose (Figure 2). The organ damage index remained stable.After a mean follow-up of 7.5 ± 5.3 months, a reduction in the number of relapses was observed, from a median [IQR] of 2 [1-6] prior ANI to 0 [0-0] after ANI (p < 0.001). The most relevant adverse events were: herpes zoster (n=5), headache (n=3), upper respiratory tract infection (n=3), pneumonia (n=3), arterial hypotension (n=2), hidradenitis suppurativa (n=2) and vaginal candidiasis (n=2). In the follow-up, 20 patients discontinued treatment due to primary failure (n=8), secondary failure (n=3), severe infections (n=6), hypotension (n=1), acute anterior uveitis (n=1), and pregnancy desire (n=1).

Conclusion: As in clinical trials, a rapid and maintained effectiveness was observed; even in severe and refractory patients. ANI was used in monotherapy or combined with other immunosuppressive drugs, including other biological therapies. The safety profile was acceptable with the limitation of short follow-up.

TABLE. Clinical manifestations and treatments received before starting anifrolumab

Abbreviations in alphabetical order: ANI: anifrolumab; AZA: azathioprine; BLM: belimumab; CsA: cyclosporine; CYM: cyclophosphamide; MMF: mycophenolate mofetil; MP: methylprednisolone; MTX: Methotrexate; RTX: rituximab

Figure 1. Evolution of C3, C4 and anti-dsDNA levels and activity and organ damage indices after starting anifrolumab.

Figure 2. Reduction in prednisone dosage after initiation of anifrolumab.

Disclosures: V. Calvo-Río: AstraZeneca, 6, MSD, Roche, AbbVie, Lilly, Celgene, Grünenthal, and UCB Pharma, 2, 6; C. Secada-Gómez: None; M. Retuerto Guerrero: None; J. Font-Urgelles: None; I. Casafont-Solé: None; A. Mayo-Juanatey: None; J. Alegre-Sancho: None; D. FREITES: None; C. Hormigos Martin: None; N. Garrido: None; G. GONZALEZ ARRIBAS: None; J. Miguelez Sanchez: None; A. García-Valle: None; M. Ibañez: None; F. Lozano Morillo: None; Á. García Manzanares: None; S. Sandoval-Moreno: None; J. Cortés-Hernández: AstraZeneca, 6, Bristol-Myers Squibb (BMS), 1, GlaxoSmithKline (GSK), 6, Novartis, 1, 5, 6; D. Palma-Sanchez: None; L. LOJO-OLIVEIRA: None; E. Cervantes: None; P. Collado Ramos: None; c. arciniega Larios: None; L. Sala: None; E. Labrador-Sánchez: None; C. Peralta-Ginés: None; N. Plaza-Aulestia: None; I. Urionaguena Onaindia: None; M. Medina Malone: None; J. Rosas Gómez de Salazar: None; M. Corteguera: None; L. Cebrian: None; F. Anton Pages: None; J. Lamua-Riazuelo: None; M. Fábregas Canales: None; M. Alados Hernández: None; M. Garijo Bufort: None; A. Pamies: None; L. Sarabia: None; R. Aguirre-del-Pino: None; J. Cabezas Lefler: None; a. seijas: None; C. Carrasco-Cubero: None; A. López-Cerón Cofiño: None; V. Ortiz-Santamaria: None; S. Castañeda: None; M. Laino: None; C. Ordás Calvo: None; C. arconada: None; a. Urruticoechea-Arana: None.

To cite this abstract in AMA style:

Calvo-Río V, Secada-Gómez C, Retuerto Guerrero M, Font-Urgelles J, Casafont-Solé I, Mayo-Juanatey A, Alegre-Sancho J, FREITES D, Hormigos Martin C, Garrido N, GONZALEZ ARRIBAS G, Miguelez Sanchez J, García-Valle A, Ibañez M, Lozano Morillo F, García Manzanares Á, Sandoval-Moreno S, Cortés-Hernández J, Palma-Sanchez D, LOJO-OLIVEIRA L, Cervantes E, Collado Ramos P, arciniega Larios c, Sala L, Labrador-Sánchez E, Peralta-Ginés C, Plaza-Aulestia N, Urionaguena Onaindia I, Medina Malone M, Rosas Gómez de Salazar J, Corteguera M, Cebrian L, Anton Pages F, Lamua-Riazuelo J, Fábregas Canales M, Alados Hernández M, Garijo Bufort M, Pamies A, Sarabia L, Aguirre-del-Pino R, Cabezas Lefler J, seijas a, Carrasco-Cubero C, López-Cerón Cofiño A, Ortiz-Santamaria V, Castañeda S, Laino M, Ordás Calvo C, arconada C, Urruticoechea-Arana a. Anifrolumab In Systemic Lupus Erythematosus. Spanish Multicenter Registry In Clinical Practice [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/anifrolumab-in-systemic-lupus-erythematosus-spanish-multicenter-registry-in-clinical-practice/. Accessed .

« Back to ACR Convergence 2025

ACR Meeting Abstracts - https://acrabstracts.org/abstract/anifrolumab-in-systemic-lupus-erythematosus-spanish-multicenter-registry-in-clinical-practice/