Lupus Nephritis of the Spanish National Registry of Belimumab in Patients with Systemic Lupus Erythematosus

María laiño¹, Monica Enguita², Pablo Navarro³, Javier Loricera⁴, Angel Garcia-Aparicio⁵, Carmen Lasa⁶, Vanesa Calvo Río⁷, Adela Gallego⁸, Clara Moriano Morales⁹, Javier Narvaez¹⁰, MARIA IRENE CARRION BARBERA¹¹, Jordi Camins-Fàbregas¹², Joaquin Maria Belzunegui Otano¹³, Ana Urruticoechea¹⁴, Leticia del Olmo Perez¹⁵, Santos Castañeda¹⁶, Patricia Quiroga¹⁶, Ivette Casafont-Sole¹⁷, Juan Ramon De Dios Jimenez De Aber¹⁸, Marta López¹⁹, Judit Font Urgelles²⁰, Rafaela Ortega Castro²¹, Marta Garijo Bufort²², Jorge Juan Fragio²³, Ignacio Vázquez²⁴, Mamen Ortega²⁵, Aaron Fariñas²⁶, Cilia Peralta²⁷, Juan María Blanco²⁸, Sergi Heredia Martin²⁹, Maria Valvanera Pinillos³⁰, Eztizen Labrador-Sánchez³¹, Piter Jose Cossio Jimenez³², Carlos Vazquez Galeano³³ and Vicente Aldasoro¹, ¹Hospital Universitario de Navarra, Pamplona, Spain, ²Navarrabiomed-Unidad de Metodología, Pamplona, Spain, ³Rheumatology, Hospial Universitario Puerta de Hierro, Majadahonda, Spain, ⁴Hospital Universitario Marqués de Valdecilla, Santander, Spain, ⁵Hospital Universitario de Toledo, Toledo, Spain, ⁶Hospital Universitario Marqués de Valdecilla, IDIVAL., La Cavada, Spain, ⁷Valdecilla Hospital, Santander, Spain, ⁸Complejo Hospitalario Universitario de Badajoz, Badajoz, Spain, ⁹Rheumatology, Hospital Universitario de León, León, Spain, ¹⁰Hospital Universitario de Bellvitge, Barcelona, Spain, ¹¹Hospital del Mar/Parc de Salut Mar-IMIM, Barcelona, Spain, ¹²Hospital General de Granollers, Granollers, Spain, ¹³University Hospital Donostia, Donostia-San Sebasti, Spain, ¹⁴Hospital Can Misses, Ibiza, Spain, ¹⁵Hospital Nuestra Señora del Prado, Talavera de la Reina, Spain, ¹⁶Hospital Universitario de la Princesa, Madrid, Spain, ¹⁷Hospital Universitari Germans Trias i Pujol, Badalona, Spain, ¹⁸Hospital de Araba, Alava, Spain, ¹⁹Hospital Universitario Arava, Pamplona, Spain, ²⁰Hospital Universitario German Trias i Pujol,, Badalona, Spain, ²¹Hospital Reina Sofía, Cordoba, Spain, ²²Hospital de Sagunto, Valencia, Spain, ²³Hospital General Universitario Valencia, Valencia, Spain, ²⁴H. U. Dr. Peset, Valencia, Spain, ²⁵Hospital Universitario de Getafe, Getafe, Spain, ²⁶Complejo Asistencial Universitario de Palencia, Palencia, Spain, ²⁷Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain, ²⁸Hospital Universitario de Basurto, Bilbao, Spain, ²⁹Complex Hospitalari Moisès Broggi, Barcelona, Spain, ³⁰Hospital Universitario San Pedro, Logroño, Spain, ³¹Hospital Universitario San Pedro, Laguardia, Spain, ³²HOSPITAL REINA SOFIA, Tudela, Spain, ³³ZARAGOZA, Madrid, Spain

Meeting: ACR Convergence 2023

Keywords: B-Cell Targets, Lupus nephritis, Systemic lupus erythematosus (SLE)

Session Information

Date: Sunday, November 12, 2023

Title: (0582–0608) SLE – Treatment Poster I

Session Type: Poster Session A

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

Background/Purpose: Belimumab (BLM) is a B-cell stimulating factor (BlyS) monoclonal antibody, approved in 2022 for the treatment of lupus nephritis (NL) and since 2011 for systemic lupus erythematosus (SLE).

Objectives. To describe the demographic characteristics, efficacy and safety of BLM in real clinical practice in patients with lupus nephritis.

Methods: A descriptive, retrospective study of patients with lupus nephritis confirmed by biopsy from the Spanish multicenter registry of patients treated with BLM. Demographic, analytical and previous and concomitant treatment with belimumab were collected. To assess efficacy, analytical variables (anti-DNA, C3, C4), Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scale, and steroid doses at baseline and throughout follow-up were analyzed. Renal improvement was considered when a 24-hour proteinuria of less than 0.5 grams was reached. Safety profile of BLM was analyzed.

Results: We included 108 patients, 81.5% women, with a mean age at diagnosis of SLE of 26.9 years (20.2-35.5).The most frequent nephritis class was IV (47 patients, 43.5%), followed by class III (23 patients, 21.3%), V (19 patients, 17.6%) and I-II (19 patients, 17.6%). The time of evolution of the disease until the onset of BLM was 8.6 years (5-15.5).62 patients (57.4%) started BLM subcutaneously (SC), 33 patients (30.6%) intravenously (IV) and 13 patients (12%) change from IV to SC route. Baseline characteristics are summarized in Table 1

The median proteinuria in 24 hours was 1.0 (0.5 to 2.5). The median number of pre-BLM cDMARD uses was 2.0 (2.0-3.0), with antimalarials being the most commonly used (91.7%). 39 and 22 patients received cyclophosphamide and bDMARD prior to BLM respectively, being Rituximab (RTX) the most commonly bDMARD used. 107 patients received prednisone at the time of starting BLM with a median dose of 7.5 (5-1.5) mg.

74.4% of patients improved after BLM in terms of reduction of proteinuria, with last 24-hour proteinuria of 0.2 (0.1-0.9) grams. A decrease in prednisone dose and SLEDAI improvement (Figure 1) was observed from baseline to last follow-up. On the other hand, a decrease in anti-DNA and an increase in C3 and C4 were observed.

21 patients (19.4%) discontinued treatment mainly due to ineffectiveness; 4 patients stopped BLM because of nephritis improvement. The median time on treatment for patients who had to discontinue BLM was 9 (6-24) months. In terms of safety, 28 patients had infections, most of them mild, being urine infection the most reported. One patient died due to meningitis. There were no tumors.

Conclusion: In this cohort of LN treated with BLM in real world settings, we observed an improvement of 24-hour proteinuria, SLEDAI, decrease of anti-DNA and increase of complement, despite of the administration route. No new safety alarms were reported.

Disclosures: M. laiño: None; M. Enguita: None; P. Navarro: None; J. Loricera: None; A. Garcia-Aparicio: None; C. Lasa: None; V. Calvo Río: None; A. Gallego: None; C. Moriano Morales: None; J. Narvaez: None; M. CARRION BARBERA: None; J. Camins-Fàbregas: None; J. Belzunegui Otano: None; A. Urruticoechea: None; L. del Olmo Perez: None; S. Castañeda: None; P. Quiroga: None; I. Casafont-Sole: None; J. Dios Jimenez De Aber: None; M. López: None; J. Font Urgelles: None; R. Ortega Castro: None; M. Garijo Bufort: None; J. Fragio: None; I. Vázquez: None; M. Ortega: None; A. Fariñas: None; C. Peralta: None; J. Blanco: None; S. Heredia Martin: None; M. Pinillos: None; E. Labrador-Sánchez: None; P. Cossio Jimenez: None; C. Vazquez Galeano: None; V. Aldasoro: None.

To cite this abstract in AMA style:

laiño M, Enguita M, Navarro P, Loricera J, Garcia-Aparicio A, Lasa C, Calvo Río V, Gallego A, Moriano Morales C, Narvaez J, CARRION BARBERA M, Camins-Fàbregas J, Belzunegui Otano J, Urruticoechea A, del Olmo Perez L, Castañeda S, Quiroga P, Casafont-Sole I, Dios Jimenez De Aber J, López M, Font Urgelles J, Ortega Castro R, Garijo Bufort M, Fragio J, Vázquez I, Ortega M, Fariñas A, Peralta C, Blanco J, Heredia Martin S, Pinillos M, Labrador-Sánchez E, Cossio Jimenez P, Vazquez Galeano C, Aldasoro V. Lupus Nephritis of the Spanish National Registry of Belimumab in Patients with Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/lupus-nephritis-of-the-spanish-national-registry-of-belimumab-in-patients-with-systemic-lupus-erythematosus/. Accessed .

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