Ambispective, Multicenter Registry of Treatment with Anifrolumab in Real Life in Patients with Systemic Lupus Erythematosus from Spanish Rheumatology Departments (ANIFRO-Reu): Efficacy, Safety and Patient’s Characteristics

Irene Carrión-Barberà¹, Tarek Carlos Salman Monte:², Laura Triginer³, María García-Villanueva⁴, Sandra Garrote Corral⁵, Anne Riveros Frutos⁶, Judit Font⁷, María Galindo-Izquierdo⁸, Carlos de Frías Polo⁹, Jorge Juan Fragío Gil¹⁰, Clara Moriano¹¹, Elvira Díez Álvarez¹², Pilar Bernabéu¹³, Paloma Vela-Casasempere¹⁴, Josefina Cortés-Hernández¹⁵, Sebastián Sandoval Moreno¹⁶, Javier Narvaez-García¹⁷, Andrea Hernández-Martín¹⁸, Berta Paula Magallares¹⁹, María Piqueras García²⁰, Carlos Marras²¹, Consuelo Ramos²², Jose Alfredo Gomez-Puerta²³, Beatriz Frade-Sosa²⁴, Ana Fernández-Ortiz²⁵, Angel Garcia-Aparicio²⁶, Irene Altabás-González²⁷, Samuel Hernández-Baldizón²⁸, Inmaculada Ros-Vilamajó²⁹, Silvia García Cirera³⁰, Marta Garijo Bufort³¹, Luis Sala³², Julia Martínez-Barrio³³, José Rosas-Gómez de Salazar³⁴, Sergi Heredia³⁵, Vicenç Torrente-Segarra³⁶, Anahy Maria Brandy-Garcia³⁷, Natividad del Val del amo³⁸, Concepción Fito-Manteca³⁸, Jaime Calvo-Alen³⁹, José María Pego-Reigosa⁴⁰ and Íñigo Rúa-Figueroa⁴¹, ¹Hospital del Mar, Barcelona, Spain, ²Hospital del Mar/Parc de Salut Mar-IMIM, Barcelona, Spain, ³Hospital del Mar Research Institute, Barcelona, Spain, ⁴Hospital Ramón y Cajal, MADRID, Madrid, Spain, ⁵Hospital Universitario Ramón y Cajal, Madrid, Spain, ⁶Hospital Universitari Germans Trias i Pujol, Barcelona, Spain, ⁷Hospital Germans Trias i Pujol, Barcelona, Spain, ⁸Hospital 12 de Octubre, Madrid, Madrid, Spain, ⁹Hospital 12 de Octubre, Madrid, Spain, ¹⁰Hospital General Universitario, Valencia, Comunidad Valenciana, Spain, ¹¹Hospital León, LEON, Spain, ¹²Complejo Asistencial Universitario de León, León, Spain, ¹³Rheumatology section, Dr. Balmis General University Hospital-ISABIAL, Alicante, Spain, Alicante, Spain, ¹⁴Hospital General Universitario Alicante, Alicante, Spain, ¹⁵Hospital Universitario Vall d´Hebrón Hospitals, Barcelona, ES, Barcelona, Spain, ¹⁶Hospital Vall d'Hebron, Barcelona, Spain, ¹⁷Hospital Universitario de Bellvitge, Barcelona, Spain, ¹⁸Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas, Spain, ¹⁹Dept of Rheumatology, Hospital de la Santa Creu I Sant Pau, Barcelona, ES, Barcelona, Spain, ²⁰Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain, ²¹Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Murcia, Spain, ²²Hospital Universitario Virgen de Valme, Sevilla, Spain, ²³Rheumatology Department, Hospital Clinic of Barcelona, Barcelona, Spain, ²⁴Hospital Clínic, Barcelona, Spain, ²⁵Hospital Universitario de Badajoz, Badajoz, Spain, ²⁶Hospital Universitario de Toledo, Toledo, Spain, ²⁷Complejo Hospitalario de Vigo, Vigo, Galicia, Spain, ²⁸Hospital Universitario Son Llàtzer, Palma de Mallorca, Spain, ²⁹Hospital Universitari Son Llàtzer, Palma de Mallorca, Islas Baleares, Spain, ³⁰Hospital Parc Taulí, Sabadell, Spain, ³¹Hospital de Sagunto, Sagunto, Spain, ³²Hospital Universitario de Torrejón, Torrejón, Spain, ³³Hospital Gregorio Marañón, Madrid, Spain, ³⁴Hospital Marina Baixa, PALMA DE MALLORCA, Comunidad Valenciana, Spain, ³⁵Hospital Moisès Broggi, Sant Joan Despí, Spain, ³⁶Hospital Comarcal Alt Penedès-Garraf, Vilafranca, Spain, ³⁷Hospital Germans Trias i Pujol, Badalona, Spain, ³⁸Complejo Universitario de Navarra, Navarra, Spain, ³⁹Hospital Universitario de Araba, Araba, Spain, ⁴⁰Galicia Health Service (SERGAS), Vigo, Spain, ⁴¹Department of Rheumatology, Hospital Universitario Doctor Negrín, Las Palmas de Gran Canaria, Las Palmas GC, Spain

Meeting: ACR Convergence 2024

Keywords: Biologicals, Systemic lupus erythematosus (SLE)

Session Information

Date: Monday, November 18, 2024

Title: SLE – Treatment Poster III

Session Type: Poster Session C

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

Background/Purpose: Anifrolumab is a biological treatment with recent approval for systemic lupus erythematosus (SLE), supported by its efficacy in clinical trials. However, data from real clinical practice are lacking. The purpose of this work is to describe patient’s baseline characteristics at the time of anifrolumab initiation, reasons for its prescription, and efficacy and adverse effects at 3 months in patients with SLE under real-life conditions followed up in Spanish rheumatology departments.

Methods: Observational, uncontrolled, ambispective and multicenter study of a cohort of patients with SLE (according to the 2019 EULAR/ACR criteria), treated with anifrolumab in 28 rheumatology departments. Patients who received at least one dose of anifrolumab were included. Sociodemographic, clinical, blood test variables and treatments, were collected. In addition, indexes or scales of activity (SLEDAI-2k, SFI, SLE-DAS, CLASI), damage (SLICC/ACR/DI), fatigue (FACIT), neuro-cognitive function (MoCA) and disease impact (LIT) at the baseline visit were calculated. The efficacy and security analysis comparing the basal and 3-month visit post initiation of anifrolumab were performed using a McNemar test for paired categorical samples for the categorical variables and a sign test for the continuous variables. Ethics Committee code: 2023/10814.

Results: 105 SLE patients were included. Table 1 shows the baseline demographic, clinical characteristics, reasons for anifrolumab initiation and treatments of the patients. We found a statistically significant difference in the SLEDAI, SLEDAS, physician global assessment, glucocorticoids dose, number of concomitant immunosuppressant drugs used, and the percentage of patients in remission (DORIS-21) or in low disease activity (LLDAS) 3 months after initiation of anifrolumab (n=61) vs the basal visit (See Figure 1). 11/59 (18.6%) underwent flares (10, 1 flare; 1, 2) during those 3 first months, of which 2 were severe (according to SFI). 40/52 (76.9%) showed a response according to the physician’s global opinion, 40/46 (86.9%) showing a response ≥ 20%, 31/46 ≥ 50% and 22/51 (43.1%) serological response. 2/57 (3.5%) patients discontinued anifrolumab due to adverse effects (1 pneumonia, 1 dyspnea) and 3 had to be hospitalized (1 serious respiratory infection, 1 SLE activity, 1 other) (Figure 2).

Conclusion: Anifrolumab was initiated in a real-life setting in patients with a long disease course and refractory to several treatments, with a predominance of mucocutaneous and joint involvement. Anifrolumab showed a significant improvement in different efficacy variables 3 months after initiation, with a relevant percentage reaching LLDAS or DORIS remission, and with barely any security events. This indicates that anifrolumab seems to be even more effective when used in real-life clinical practice as compared to clinical trials.

Table 1: Demographic and clinic characteristics of the patients at baseline. p25: percentile 25; p75: percentile 75. SLEDAI: systemic lupus erythematosus disease activity score; SLE-DAS: systemic lupus erythematosus disease activity score; CLASI: cutaneous lupus erythematosus disease area and severity index; LIT: lupus impact tracker; MOCA: The Montreal Cognitive Assessment; FACIT-F: Functional Assessment of Chronic Illness Therapy – Fatigue).

Figure 1: Statistically significant differences in efficacy indexes between the basal visit and the one 3 months after anifrolumab initiation. **** means p-value<0.0001. a: SLEDAI: systemic lupus erythematosus disease activity index (n=49), b: SLE-DAS: systemic lupus erythematosus disease score (n=36); c: PGA: physician global assessment (n=41); d: corticosteroids dosage (n=43); e: number of immunosuppressant drugs combined with anifrolumab (n=61); f: DORIS: definition of remission in systemic lupus erythematosus (n=54); g: LLDAS: lupus low disease activity (n=55).

Figure 2: Percentage of patients that stopped anifrolumab before the 3-month visit post treatment or that developed complications (new depression, hospital admission, death, severe infections).

Disclosures: I. Carrión-Barberà: AstraZeneca, 6, GlaxoSmithKlein(GSK), 6, Otsuka, 6; T. Salman Monte:: AstraZeneca, 2, 5, 6, GlaxoSmithKlein(GSK), 2, 5, 6, Otsuka, 2, 6; L. Triginer: None; M. García-Villanueva: None; S. Garrote Corral: None; A. Riveros Frutos: None; J. Font: None; M. Galindo-Izquierdo: None; C. de Frías Polo: None; J. Fragío Gil: None; C. Moriano: None; E. Díez Álvarez: None; P. Bernabéu: None; P. Vela-Casasempere: None; J. Cortés-Hernández: None; S. Sandoval Moreno: None; J. Narvaez-García: None; A. Hernández-Martín: None; B. Paula Magallares: None; M. Piqueras García: None; C. Marras: None; C. Ramos: None; J. Gomez-Puerta: AstraZeneca, 6, Boehringer-Ingelheim, 6, Eli Lilly, 6, GlaxoSmithKlein(GSK), 6, Janssen, 6, Otsuka, 6; B. Frade-Sosa: None; A. Fernández-Ortiz: None; A. Garcia-Aparicio: None; I. Altabás-González: AstraZeneca, 6, GlaxoSmithKlein(GSK), 6; S. Hernández-Baldizón: None; I. Ros-Vilamajó: None; S. García Cirera: None; M. Garijo Bufort: None; L. Sala: None; J. Martínez-Barrio: None; J. Rosas-Gómez de Salazar: None; S. Heredia: None; V. Torrente-Segarra: None; A. Brandy-Garcia: None; N. del Val del amo: None; C. Fito-Manteca: None; J. Calvo-Alen: None; J. Pego-Reigosa: AstraZeneca, 1, 6, GSK, 5, 6, Otsuka, 1, Pfizer, 5, Roche, 1; Í. Rúa-Figueroa: AstraZeneca, 2, 6, GlaxoSmithKlein(GSK), 2, 6, Otsuka, 2, 6.

To cite this abstract in AMA style:

Carrión-Barberà I, Salman Monte: T, Triginer L, García-Villanueva M, Garrote Corral S, Riveros Frutos A, Font J, Galindo-Izquierdo M, de Frías Polo C, Fragío Gil J, Moriano C, Díez Álvarez E, Bernabéu P, Vela-Casasempere P, Cortés-Hernández J, Sandoval Moreno S, Narvaez-García J, Hernández-Martín A, Paula Magallares B, Piqueras García M, Marras C, Ramos C, Gomez-Puerta J, Frade-Sosa B, Fernández-Ortiz A, Garcia-Aparicio A, Altabás-González I, Hernández-Baldizón S, Ros-Vilamajó I, García Cirera S, Garijo Bufort M, Sala L, Martínez-Barrio J, Rosas-Gómez de Salazar J, Heredia S, Torrente-Segarra V, Brandy-Garcia A, del Val del amo N, Fito-Manteca C, Calvo-Alen J, Pego-Reigosa J, Rúa-Figueroa Í. Ambispective, Multicenter Registry of Treatment with Anifrolumab in Real Life in Patients with Systemic Lupus Erythematosus from Spanish Rheumatology Departments (ANIFRO-Reu): Efficacy, Safety and Patient’s Characteristics [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/ambispective-multicenter-registry-of-treatment-with-anifrolumab-in-real-life-in-patients-with-systemic-lupus-erythematosus-from-spanish-rheumatology-departments-anifro-reu-efficacy-safety-and-pat/. Accessed .

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