Anifrolumab in Systemic Lupus Erythematosus. Spanish National Registry in a Real-world Setting

Carmen Secada Gómez¹, Vanesa Calvo-Rio², Miriam Retuerto Guerrero³, Judit Font⁴, Ivette Casafont-Sole⁵, Adrián Mayo-Juanatey⁶, Juan José Alegre Sancho⁶, Dalifer Freites Nuñez⁷, Cristina Hormigos⁸, Noemí Garrido-Puñal⁹, GUILLERMO GONZALEZ ARRIBAS¹⁰, Andrea García-Valle¹¹, Juan Roberto Miguelez Sanchez¹², Marta Ibáñez Martínez¹³, Fernando Lozano Morillo¹⁴, Ángel García Manzanares¹⁵, Sebastián Sandoval-Moreno¹⁶, Josefina Cortés-Hernández¹⁷, Desiree Palma¹⁸, Leticia Lojo Oliveira¹⁹, EVELIN CERVANTES PEREZ²⁰, PAZ COLLADO²¹, Cristina Arciniega Larios²², Luis Sala Icardo²³, Eztizen Labrador-Sánchez²⁴, Cilia Peralta Ginés²⁵, Nahia Plaza-Aulestia²⁶, Miguel Medina Malone²⁷, José Rosas-Gómez de Salazar²⁸, Montserrat Corteguera²⁹, Laura Cebrián¹⁹, Fred Anton Pages³⁰, JOSE RAMON LAMUA RIAZUELO³¹, maria Dolores Fábregas canales³², María José Alados Hernández³³, Marta Garijo Bufort³⁴, Anna Pamies Corts³⁵, Luis Sarabia De Ardanaz³⁶, Rodrigo Aguirre-del-Pino³⁷, José Ángel Cabezas Lefler³⁸, Álvaro Seijas-Lopez³⁷, Carmen Carrasco-Cubero³⁹, Ana López-Cerón Cofiño⁴⁰, Vera Ortiz-Santamaria⁴¹, Santos Castañeda⁴², María Laiño Piñeiro⁴³, Carmen Ordás Calvo⁴⁴, Celia Arconada Lopez⁴⁵, Carmen Bejerano⁴⁶ and Ricardo Blanco-Alonso⁴⁷, ANA URRUTICOECHEA⁴⁸, Blanca Garcia-Magallon⁴⁹, Ana Valeria Acosta Alfaro⁵⁰, Samuel Leal Rodriguez⁵¹, Marina Salido Olivares⁵² and Patricia Lavilla⁵³ ¹Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ²Valdecilla Hospital, Santander, Cantabria, Spain, ³Complejo Asistencial Universitario de León, Leon, Spain, ⁴Hospital Germans Trias i Pujol, Barcelona, Spain, ⁵Hospital Universitari Germans Trias i Pujol, Badalona, Spain, ⁶Hospital Universitario Doctor Peset, Valencia, Spain, ⁷Hospital Clínico San Carlos. Madrid. Spain., Madrid, Spain, ⁸Hospital Clínico San Carlos, Madrid, Madrid, Spain, ⁹Hospital Universitario Virgen del Rocío, Sevilla, Spain, ¹⁰Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain, ¹¹Hospital General Río Carrión, Palencia, Spain, ¹²Hospital Universitario de Móstoles, Madrid, Spain, ¹³Hospital Clínico Universitario de Salamanca, Salamanca, Spain, ¹⁴Hospital Central de La Defensa Gómez Ulla, Madrid, Spain, ¹⁵Hospital Universitario de Torrevieja, Alicante, Spain, ¹⁶Hospital Universitario Vall d´Hebrón, Barcelona, Spain, ¹⁷Hospital Universitario Vall d´Hebrón Hospitals, Barcelona, ES, Barcelona, Spain, ¹⁸Hospital Rafael Méndez, Lorca, Murcia, Spain, ¹⁹Hospital Universitario Infanta Leonor, Madrid, Spain, ²⁰Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Galicia, Spain, ²¹Hospital Universitario Severo Ochoa, MADRID, Spain, ²²Hospital de Mérida, Badajoz, Spain, ²³Hospital Universitario de Torrejón, Madrid, Spain, ²⁴Hospital General de La Rioja, Logroño, Spain, ²⁵Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain, ²⁶Hospital Galdakao, Vizcaya, Spain, ²⁷Hospital Calahorra, La Rioja, Spain, ²⁸Hospital Marina Baixa, PALMA DE MALLORCA, Comunidad Valenciana, Spain, ²⁹ComplejoAsistencial de Ávila, Ávila, Spain, ³⁰Complejo Asistencial De Segovia, Segovia, Spain, ³¹Hospital Universitario del Henares, Madrid, Spain, ³²Hospital de Barbastro, Huesca, Spain, ³³Hospital Universitario Puerta del Mar, Cádiz, Spain, ³⁴Hospital de Sagunto, Valencia, Spain, ³⁵Hospital Verge de la Cinta, Tortosa, TARRAGONA, Spain, ³⁶Complejo Hospitalario de Jaén, Jaén, Spain, ³⁷Hospital Universitario Lucus Augusti, Lugo, Spain, ³⁸Complejo Asistencial de Zamora, Zamora, Spain, ³⁹Complejo Hospitalario Universitario de Badajoz, Badajoz, Spain, ⁴⁰Hospital Santa Bárbara, Soria, Spain, ⁴¹Hospital General de Granollers, Barcelona, Spain, ⁴²Hospital Universitario de la Princesa, Madrid, Spain, ⁴³Hospital Universitario de Navarra, Pamplona, Spain, ⁴⁴Hospital Universitario de Cabueñes, Gijón, Spain, ⁴⁵Hospital Universitario Infanta Elena, Valdemoro, Madrid, Spain, ⁴⁶Hospital Universitario Marques de Valdecilla, Immunopathology group, IDIVAL, Santander, Cantabria, Spain, ⁴⁷Division of Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Immunopathology group, Santander, Spain, ⁴⁸Hospital Universitario Son Espases, Palma de Mallorca, Islas Baleares, Spain, ⁴⁹Hospital Universitario Puerta de Hierro Majadahonda., Madrid, Spain, ⁵⁰Hospital Universitario Infanta Sofía, Madrid, Spain, ⁵¹HUP La Fe, Valencia, Spain, ⁵²Hospital Infanta Cristina, Parla, Spain, ⁵³Hospital General de Villalba, Collado Villalba, Spain

Meeting: ACR Convergence 2024

Keywords: autoimmune diseases, Biologicals, Systemic lupus erythematosus (SLE)

Session Information

Date: Sunday, November 17, 2024

Title: SLE – 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), thus blocking the biological activity of type I interferon. ANI was approved by Spanish authorities on June 1, 2023, for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) with positive autoantibodies, in combination with standard treatment.

Objectives: To describe the clinical practice of ANI in SLE in Spain, reviewing a) the profile of patients receiving ANI, b) effectiveness, and c) safety.

Methods: Descriptive, retrospective, multicenter study of patients diagnosed with SLE according to EULAR/ACR 2019, SLICC, and/or ACR 1997 diagnostic criteria. Data were collected from medical records up to January 2024. Demographic, clinical, and laboratory variables, previous and concomitant therapy, activity indices (SLE-DAS, SLEDAI-2k, PGA), organ damage index (SLICC SDI), and safety were evaluated.

Results: A total of 113 patients (99 females / 14 males), mean age 44.6 ± 11.18 years (range 15-70 years) (47 hospitals) were included. Baseline characteristics of patients and previous treatment before ANI are summarized in the table.

The main reason for starting ANI was clinical/activity: cutaneous (n=72, 63.7%), articular (n=61, 53.9%), hematological (n=29, 25.6%), corticosteroid dependence (n=5, 4.4%), renal (n=2, 1.7%), serious adverse events with belimumab (BLM) (n=2, 1.7%), serositis (n=1, 0.9%), neurological (n=1, 0.9%), and Kikuchi disease (n=1, 0.9%).

All patients received 300 mg/4 weeks of ANI except one patient with renal involvement who received a loading dose (900 mg/4 weeks x3 months followed by 300 mg/4 weeks).

52.2% of patients received concomitant treatment with corticosteroids and/or antimalarials only. The remaining 47.8% received the following concomitant immunosuppressants with ANI: mycophenolate mofetil (MMF) (n=29), methotrexate (MTX) (n=15), azathioprine (AZA) (n=6), tacrolimus (n=5), rituximab (RTX) (n=3), leflunomide (LFN) (n=2), cyclophosphamide (CYM) (n=1), sulfones (n=2), and anakinra (n=1).

Significant, rapid improvement (from the 1st month) was observed in a) activity (SLE-DAS, SLEDAI-2k, PGA); as well as b) serological (decrease in anti-DNA antibody titers, increase in C3 and C4 levels) (Figure). The organ damage index remained stable.

After a mean follow-up of 4.4 ± 3.5 months, the main observed adverse effects were: herpes zoster (n=3), headache (n=3), arterial hypotension (n=2), hidradenitis suppurativa (n=2), influenza A pneumonia (n=1), skin reaction (n=1), herpes simplex virus infection, and urinary tract infection (n=1). In follow-up, 8 patients discontinued treatment due to primary failure (n=4), secondary failure (n=2), severe pneumonia (n=1), arterial hypotension (n=1).

Conclusion: To our knowledge, this series is the largest of ANI in patients with SLE in clinical practice showing effectiveness and safety data. We observed rapid effectiveness in severe and refractory patients; ANI was even used in combination with other biological therapies. The safety profile was acceptable with the limitation of short follow-up. These preliminary data should be confirmed in larger series with longer follow-up.

TABLE. Clinical manifestations and treatments received before starting anifrolumab
Abbreviations in alphabetical order: ANI: anifrolumab; AZA: azathioprine; BLM: belimumab; CYM: cyclophosphamide; MMF: mycophenolate mofetil; MP: methylprednisolone; MTX: Methotrexate; RTX: rituximab

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

Disclosures: C. Secada Gómez: None; V. Calvo-Rio: AstraZeneca, 6, GlaxoSmithKlein(GSK), 6, Janssen, 6, otsuka, 6; M. Retuerto Guerrero: None; J. Font: None; I. Casafont-Sole: None; A. Mayo-Juanatey: None; J. Alegre Sancho: None; D. Freites Nuñez: None; C. Hormigos: None; N. Garrido-Puñal: None; G. GONZALEZ ARRIBAS: None; A. García-Valle: None; J. Miguelez Sanchez: None; M. Ibáñez Martínez: None; F. Lozano Morillo: None; Á. García Manzanares: None; S. Sandoval-Moreno: None; J. Cortés-Hernández: None; D. Palma: None; L. Lojo Oliveira: None; E. CERVANTES PEREZ: None; P. COLLADO: None; C. Arciniega Larios: None; L. Sala Icardo: None; E. Labrador-Sánchez: None; C. Peralta Ginés: None; N. Plaza-Aulestia: None; M. Medina Malone: None; J. Rosas-Gómez de Salazar: None; M. Corteguera: None; L. Cebrián: None; F. Anton Pages: None; J. LAMUA RIAZUELO: None; m. Fábregas canales: None; M. Alados Hernández: None; M. Garijo Bufort: None; A. Pamies Corts: None; L. Sarabia De Ardanaz: None; R. Aguirre-del-Pino: None; J. Cabezas Lefler: None; Á. Seijas-Lopez: None; C. Carrasco-Cubero: None; A. López-Cerón Cofiño: None; V. Ortiz-Santamaria: None; S. Castañeda: Bristol-Myers Squibb(BMS), 2, 6, Eli Lilly, 2, 6, Merck/MSD, 2, 5, 6, Pfizer, 5, Roche, 2, 6, UCB, 2, 5; M. Laiño Piñeiro: None; C. Ordás Calvo: None; C. Arconada Lopez: None; C. Bejerano: None; R. Blanco-Alonso: AbbVie, 2, 5, 6, Bristol-Myers Squibb, 2, 6, Galapagos, 6, Janssen, 2, 6, Lilly, 2, 6, MSD, 2, 5, 6, Pfizer, 2, 6, Roche, 2, 5, 6. A. URRUTICOECHEA: AbbVie/Abbott, 6, Amgen, 6, Galápagos, 6, GlaxoSmithKlein(GSK), 1, Janssen, 6, Lilly, 6, Novartis, 1, UCB, 6; B. Garcia-Magallon: None; A. Acosta Alfaro: None; S. Leal Rodriguez: None; M. Salido Olivares: None; P. Lavilla: None

To cite this abstract in AMA style:

Secada Gómez C, Calvo-Rio V, Retuerto Guerrero M, Font J, Casafont-Sole I, Mayo-Juanatey A, Alegre Sancho J, Freites Nuñez D, Hormigos C, Garrido-Puñal N, GONZALEZ ARRIBAS G, García-Valle A, Miguelez Sanchez J, Ibáñez Martínez M, Lozano Morillo F, García Manzanares Á, Sandoval-Moreno S, Cortés-Hernández J, Palma D, Lojo Oliveira L, CERVANTES PEREZ E, COLLADO P, Arciniega Larios C, Sala Icardo L, Labrador-Sánchez E, Peralta Ginés C, Plaza-Aulestia N, Medina Malone M, Rosas-Gómez de Salazar J, Corteguera M, Cebrián L, Anton Pages F, LAMUA RIAZUELO J, Fábregas canales m, Alados Hernández M, Garijo Bufort M, Pamies Corts A, Sarabia De Ardanaz L, Aguirre-del-Pino R, Cabezas Lefler J, Seijas-Lopez Á, Carrasco-Cubero C, López-Cerón Cofiño A, Ortiz-Santamaria V, Castañeda S, Laiño Piñeiro M, Ordás Calvo C, Arconada Lopez C, Bejerano C, Blanco-Alonso R, URRUTICOECHEA A, Garcia-Magallon B, Acosta Alfaro A, Leal Rodriguez S, Salido Olivares M, Lavilla P. Anifrolumab in Systemic Lupus Erythematosus. Spanish National Registry in a Real-world Setting [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/anifrolumab-in-systemic-lupus-erythematosus-spanish-national-registry-in-a-real-world-setting/. Accessed .

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