Spanish National Registry of Belimumab in Patients with Systemic Lupus Erythematosus

María laiño¹, Monica Enguita², Javier Loricera³, Clara Moriano Morales⁴, Carmen Lasa⁵, Vanesa Calvo Río⁶, Javier Narvaez⁷, Pablo Ignacio Navarro Guerra⁸, Ivette Casafont-Sole⁹, Judit Font Urgelles¹⁰, Adela Gallego¹¹, Irene Carrión-Barberà¹², Patricia Quiroga¹³, Santos Castañeda¹³, Angel Garcia-Aparicio¹⁴, Joaquin Maria Belzunegui Otano¹⁵, Juan Ramon De Dios¹⁶, Marta López¹⁷, Samuel Hernandez¹⁸, Sergi Heredia Martin¹⁹, Aaron Fariñas²⁰, Francisco Navarro²¹, Jorge Juan Fragio²², Carmen Escudero²³, Rafaela Ortega Castro²⁴, Leticia del Olmo Perez²⁵, Valvanera Pinillos²⁶, Eztizen Labrador²⁶, Mamen Ortega²⁷, Patricia Castro Pérez²⁷, Juan Maria Blanco-Madrigal²⁸, Marcos Paulino²⁹, María Ángeles Matías³⁰, Enrique Calvo-Aranda³¹, Cilia Peralta³², Silvia García³³, Jordi Camins-Fàbregas³⁴, Marta Garijo Bufort³⁵, Dolores Fabregas³⁶, Ana Urruticoechea³⁷, Miguel Medina Malone³⁸, Piter Jose Cossio Jimenez³⁹, Eva Perez-Pampin⁴⁰, Blanca Varas de Dios⁴¹, Carlos Vazquez Galeano⁴², Nuria Vegas Revenga⁴³, Olga Rusinovich⁴⁴, Emilio Giner-Serret⁴⁵, Jose Ramón lamúa⁴⁶ and Vicente Aldasoro¹, ¹Hospital Universitario de Navarra, Pamplona, Spain, ²Navarrabiomed-Unidad de Metodología, Pamplona, Spain, ³Hospital Universitario Marqués de Valdecilla, Santander, Spain, ⁴Rheumatology, Hospital Universitario de León, León, Spain, ⁵Hospital Universitario Marqués de Valdecilla, IDIVAL., La Cavada, Spain, ⁶Valdecilla Hospital, Santander, Spain, ⁷Hospital Universitario de Bellvitge, Barcelona, Spain, ⁸Hospital Universitario Puerta de Hierro de Majadahonda, Madrid, Spain, ⁹Hospital Universitari Germans Trias i Pujol, Badalona, Spain, ¹⁰Hospital Universitario German Trias i Pujol,, Badalona, Spain, ¹¹Complejo Hospitalario Universitario de Badajoz, Badajoz, Spain, ¹²Hospital del Mar, Barcelona, Spain, ¹³Hospital Universitario de la Princesa, Madrid, Spain, ¹⁴Hospital Universitario de Toledo, Toledo, Spain, ¹⁵University Hospital Donostia, Donostia-San Sebasti, Spain, ¹⁶Hospital Universitario Araba, Vitoria, Spain, ¹⁷Hospital Universitario Arava, Pamplona, Spain, ¹⁸Hospital Universitario Son Llatzer, Palma de Mallorca, Spain, ¹⁹Complex Hospitalari Moisès Broggi, Barcelona, Spain, ²⁰Complejo Asistencial Universitario de Palencia, Palencia, Spain, ²¹Doctor. Rheumatology, Alicante, Spain, ²²Hospital General Universitario Valencia, Valencia, Spain, ²³Hospital Universitario de Valme, Sevilla, Spain, ²⁴Hospital Reina Sofía, Cordoba, Spain, ²⁵Hospital Nuestra Señora del Prado, Talavera de la Reina, Spain, ²⁶Hospital Universitario San Pedro, Logroño, Spain, ²⁷Hospital Universitario de Getafe, Getafe, Spain, ²⁸Division of Rheumatology, H. Universitario de Basurto, Bilbao, Spain, ²⁹Hospital General Universitario de Ciudad Real, Ciudad Real, Spain, ³⁰Hospital Universitario Infanta Leonor/Rheumatology Department, Madrid, Spain, ³¹Hospital Universitario Infanta Leonor, Madrid, Spain, ³²Hospital Clínico Lozano Blesa, Zaragoza, Spain, ³³Hospital Parc Taulí, Sabadell, Spain, ³⁴Hospital General de Granollers, Granollers, Spain, ³⁵Hospital de Sagunto, Valencia, Spain, ³⁶Hospital de Barbastro, Barbastro, Spain, ³⁷Hospital Can Misses, Ibiza, Spain, ³⁸Hospital Calahorra, Calahorra, Spain, ³⁹HOSPITAL REINA SOFIA, Tudela, Spain, ⁴⁰Rheumatology Department Complejo Hospitalario Universitario Santiago, Santiago de compostela, Spain, ⁴¹Santa Cristina Universitary Hospital, Madrid, Spain, ⁴²ZARAGOZA, Madrid, Spain, ⁴³Hospital Galdakao- Usansolo, Galdakao, Spain, ⁴⁴Puerta de Hierro University Hospital, Boadilla del Monte, Spain, ⁴⁵Hospital Royo Villanova, Teruel, Spain, ⁴⁶Hospital Universitario del Henares, Alcalá de Henares, Spain

Meeting: ACR Convergence 2023

Keywords: B-Lymphocyte, registry, Systemic lupus erythematosus (SLE)

Session Information

Date: Tuesday, November 14, 2023

Title: (2326–2351) SLE – Treatment Poster III

Session Type: Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Belimumab (BLM) is a monoclonal antibody that inhibits B-lymphocyte stimulating factor (BlyS), approved in 2011 as a treatment for systemic lupus erythematosus (SLE). We present the experience with BLM in this spanish cohort.

Methods: Descriptive, retrospective, multicenter study in patients diagnosed with SLE according to EULAR/ACR 2019, SLICC and/or ACR 1997 diagnostic criteria. Data regarding SLE patients treated with BLM were collected from medical records (2011-2023). Demographic features, analytical variables, SLEDAI, renal involvement, steroid dose, administration routes, efficacy, remission and safety were assessed.

Results: Five hundred and twenty one patients were included with a mean age at diagnosis of 35.1 (13.9) years. 85.8% were women. The mean age at BLM begins was 44.5 (13.3) years and the median time from SLE diagnosis to BLM begin was 6.5 (2.4-14.3) years. Regarding administration route 50.2% were on intravenous (IV), 34.6 % on subcutaneous (SC) and 15.2% change from IV to SC route. The mean time of follow-up was 24.0 (21.4) months.

Baseline characteristics are summarized in Table 1 and patients in remission are shown in figure 1.

The median number of pre-BLM cDMARD use was 2.0 (2.0-3.0), being hydroxychloroquine (HCQ) the most used (94.2%). 93 patients received bDMARD before BLM begins, being Rituximab (RTX) the most used (79.6%), and 59 patients were treated with IV cyclophosphamide (CFM) with a median of 6 (4.5-8) IV bolus received. 75.6% and 21.5% of patients were on treatment with HCQ and methotrexate when BLM was started respectively.

The main reasons of starting BLM were musculoskeletal and mucocutaneous disorders (table1).

503 patients were on prednisone at the time of BLM begin with a median dose of 7.5 (5-10) mg. A statistically significant decrease in prednisone dose, SLEDAI and DNA was observed from baseline until the last follow up. In the other hand complement C3 and C4 raised (figure2).

One hundred and thirty seven patients (28.2%) had renal involvement. The median 24 hours proteinuria was 1.0 (0.5-2.4) grams and renal biopsy was done in 114 out of 137 patients, being class IV (42%), III (18.8%), II (12.5%) and V (10.7%) the most reported. 72.2% improve after BLM begins with last 24 hour proteinuria median of 0.2 (0.1-0.8) grams. Prior to BLM, most of them had been treated with MMF, RTX or CFM.

One hundred and and fitty one patients (29%) discontinued treatment mostly due to inefficacy (57.1%) and infections (12.2%). 133 patients developed infections, most of them mild, being urinary infection the most reported. 3 patients died, 8 had COVID and 3 presented neoplasms requiring discontinuation of the drug. The median time on treatment of patients that had to stop BLM was 12.0 (6-24) months.

Conclusion: Almost half of patients achieved remission after 4 years of BLM and a statistically significant improvement in prednisone dose reduction, SLEDAI, complement and antiDNA was demonstrated. Corticosteroids sparing effect with BLM was also observed.

BLM seems to be a good choice for patients with lupus nephritis since nearly three quarters of them normalized proteinuria values. No new safety alarms were reported.

This is the largest cohort of SLE patients treated with BLM reported in one country.

Table 1: Baseline characteristics of patients included in Belimumab Spanish registry.

Figure 1: Remission define as SLEDAI ≤ 2 and ≤ 5 mg of prednisone (A) or SLEDAI ≤ 0 and ≤ 5 mg of prednisone (B).

Figure 2: Time dependant evolution of SLEDAI, prednisone, antiDNA and complement C3 and C4.

Disclosures: M. laiño: None; M. Enguita: None; J. Loricera: None; C. Moriano Morales: None; C. Lasa: None; V. Calvo Río: None; J. Narvaez: None; P. Navarro Guerra: None; I. Casafont-Sole: None; J. Font Urgelles: None; A. Gallego: None; I. Carrión-Barberà: None; P. Quiroga: None; S. Castañeda: None; A. Garcia-Aparicio: None; J. Belzunegui Otano: None; J. De Dios: None; M. López: None; S. Hernandez: None; S. Heredia Martin: None; A. Fariñas: None; F. Navarro: None; J. Fragio: None; C. Escudero: None; R. Ortega Castro: None; L. del Olmo Perez: None; V. Pinillos: None; E. Labrador: None; M. Ortega: None; P. Castro Pérez: None; J. Blanco-Madrigal: None; M. Paulino: None; M. Matías: None; E. Calvo-Aranda: None; C. Peralta: None; S. García: None; J. Camins-Fàbregas: None; M. Garijo Bufort: None; D. Fabregas: None; A. Urruticoechea: None; M. Medina Malone: None; P. Cossio Jimenez: None; E. Perez-Pampin: None; B. Varas de Dios: None; C. Vazquez Galeano: None; N. Vegas Revenga: None; O. Rusinovich: None; E. Giner-Serret: None; J. lamúa: None; V. Aldasoro: None.

To cite this abstract in AMA style:

laiño M, Enguita M, Loricera J, Moriano Morales C, Lasa C, Calvo Río V, Narvaez J, Navarro Guerra P, Casafont-Sole I, Font Urgelles J, Gallego A, Carrión-Barberà I, Quiroga P, Castañeda S, Garcia-Aparicio A, Belzunegui Otano J, De Dios J, López M, Hernandez S, Heredia Martin S, Fariñas A, Navarro F, Fragio J, Escudero C, Ortega Castro R, del Olmo Perez L, Pinillos V, Labrador E, Ortega M, Castro Pérez P, Blanco-Madrigal J, Paulino M, Matías M, Calvo-Aranda E, Peralta C, García S, Camins-Fàbregas J, Garijo Bufort M, Fabregas D, Urruticoechea A, Medina Malone M, Cossio Jimenez P, Perez-Pampin E, Varas de Dios B, Vazquez Galeano C, Vegas Revenga N, Rusinovich O, Giner-Serret E, lamúa J, Aldasoro V. Spanish National Registry of Belimumab in Patients with Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/spanish-national-registry-of-belimumab-in-patients-with-systemic-lupus-erythematosus-2/. Accessed .

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