AB1000 ANIFROLUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS. SPANISH NATIONAL REGISTRY IN A REAL-WORLD SETTING
Authors: V. Calvo-Río, M. Retuerto-Guerrero, J. Font, I. Casafont-Solé, A. Mayo-Juanatey, J. J. Alegre Sancho, D. Freites, C. Hormigos, N. Garrido-Puñal, G. Gonzalez Arribas, J. R. Miguelez Sanchez, A. García-Valle, M. Ibañez, F. Lozano Morillo, Á. García Manzanares, S. Sandoval-Moreno, J. Cortés-Hernández, D. Palma Sanchez, L. Lojo, E. C. Cervantes Pérez, P. Collado, C. Arciniega Larios, L. Sala Icardo, E. Labrador-Sánchez, C. Peralta-Ginés, N. Plaza-Aulestia, M. Medina Malone, J. Rosas Gómez de Salazar, M. Corteguera, L. Cebrián-Méndez, F. A. Anton Pages, J. R. Lamúa Riazuelo, M. D. Fábregas Canales, M. J. Alados Hernández, M. Garijo Bufort, A. Pàmies, L. Sarabia De Ardanaz, R. Aguirre-del-Pino, J. A. Cabezas Lefler, A. Seijas-Lopez, M. D. C. Carrasco Cubero, A. Lopez-Ceron Cofiño, V. Ortiz-Santamaria, S. Castañeda, C. Bejerano, R. Blanco
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> 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 IFNs. ANI was approved by Spanish authorities on June 1, 2023. Its use is indicated in adults with moderately to severely active autoantibody-positive systemic lupus erythematosus (SLE) in combination with standard treatment. <h3>Objectives:</h3> To describe in Spanish clinical practice since its approval a) SLE profile of patients, b) effectiveness and c) safety. <h3>Methods:</h3> Descriptive, retrospective, multicenter study in patients diagnosed with SLE according to EULAR/ACR 2019, SLICC and/or ACR 1997 diagnostic criteria. Data regarding were collected from medical records (June 2023-January 2024). Demographic features, clinical and laboratory variables, previous and concomitant therapy, activity index (SLE-DAS, SLEDAI-2k, PGA), organic damage index (SLICC SDI) and safety were assessed. <h3>Results:</h3> Baseline characteristics of patients and therapy before ANI are summarized in <b>Table 1</b>. A total of 91 patients (82 women/9 men), mean age 32.7±11.5 years (range 15-59 years) (38 hospitals) were included. The main reason for starting ANI was: skin activity (n=60, 65.9%), joint activity (n=52, 57.1%), hematological activity (n=25, 27.5%), renal activity (n=2, 2.2%), corticosteroids dependence (n=5, 5.5%) and serious side effects with belimumab (BLM) (n=2, 2.2%). All patients received 300 mg/4 w of ANI except one patient who received a loading dose (900 mg/4 w x3 months and after 300 mg/4 w) due to renal involvement. Concomitant treatments with ANI were: corticosteroids (n=78), antimalarials (n=68), mycophenolate mofetil (MMF) (n=23), methotrexate (MTX) (n=13), azathioprine (AZA) (n=5), tacrolimus (n=5), leflunomide (LFN) (n=2), rituximab (RTX) (n=1), cyclophosphamide (CYM) (n=1), sulfones (n=2) and anakinra (n=1). A rapid and maintained significant decreases in SLE-DAS, SLEDAI-2k, PGA and anti-dsDNA antibodies were observed from 1 month until the last visit. Complement C3 and C4 levels also increased significantly (<b>Figure 1</b>). No increase in the chronicity index was observed. After a follow-up of 4.8±3.6 months the main side effects observed were: herpes zoster (n=3), arterial hypotension (n=2), headache (n=2), suppurative hidradenitis (n=1), influenza A pneumonia (n=1), skin reaction (n=1), herpes simplex virus infection and urinary infection (n=1). In follow-up, 7 patients discontinued treatment due to primary failure (n=3), secondary failure (n=2), severe pneumonia (n=1), arterial hypotension (n=1). <h3>Conclusion:</h3> In our cohort of SLE patients in a real-world setting, ANI has showed a rapid effectiveness, and a relatively good safety. Therefore, ANI seems to be a good choice to treat patients refractory to other therapies. ANI in severe and refractory patients even was used combined with other biologic therapy. <h3>REFERENCES:</h3> [1] Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis. 2019 Sep;78(9):1151-1159. <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> Vanesa Calvo-Río Abbie, Lilly, Grünenthal, AMGEN, MSD, Novartis, Galápagos, Vifor, GSK, Otsuka, Janssen, M. Retuerto-Guerrero: None declared, Judit Font: None declared, Ivette Casafont-Solé: None declared, A. Mayo-Juanatey: None declared, Juan Jose Alegre Sancho: None declared, Dalifer Freites: None declared, Cristina Hormigos: None declared, Noemí Garrido-Puñal: None declared, Guillermo Gonzalez Arribas: None declared, Juan Roberto Miguelez Sanchez: None declared, Andrea García-Valle: None declared, Marta Ibañez: None declared, Fernando Lozano Morillo: None declared, Ángel García Manzanares: None declared, S. Sandoval-Moreno: None declared, Josefina Cortés-Hernández: None declared, Deseada Palma Sanchez: None declared, Leticia Lojo: None declared, Evelin Cecilia Cervantes Pérez: None declared, Paz Collado: None declared, Cristina Arciniega Larios: None declared, Luis Sala Icardo: None declared, Eztizen Labrador-Sánchez: None declared, Cilia Peralta-Ginés: None declared, Nahia Plaza-Aulestia: None declared, Miguel Medina Malone: None declared, Jose Rosas Gómez de Salazar: None declared, Montserrat Corteguera: None declared, Laura Cebrián-Méndez: None declared, Fred Antonio Anton Pages: None declared, Jose Ramón Lamúa Riazuelo: None declared, Maria Dolores Fábregas Canales: None declared, María José Alados Hernández: None declared, Marta Garijo Bufort: None declared, Anna Pàmies: None declared, Luis Sarabia De Ardanaz: None declared, Rodrigo Aguirre-del-Pino: None declared, Jose Angel Cabezas Lefler: None declared, Alvaro Seijas-Lopez: None declared, Maria del Carmen Carrasco Cubero: None declared, Ana Lopez-Ceron Cofiño: None declared, Vera Ortiz-Santamaria: None declared, Santos Castañeda: None declared, Carmen Bejerano: None declared, Ricardo Blanco Abbvie, Pfizer, Roche, Bristol-Myers-Squibb, Janssen, Lilly, Novartis, UCB, and MSD, Abbvie, MSD, Roche.