1457: Baseline Characteristics of a Longitudinal, Multinational, Multiethnic Study of Lupus Patients, with or Without Lupus Nephritis

Romina Nieto¹, Rosana Quintana², eduardo Borba³, Lucia Hernandez⁴, Diana Fernandez-Avila⁵, Laura Maurelli⁶, Paul Alba⁷, Florencia Bordon⁸, Fernando Arizpe⁹, Guillermo Berbotta¹⁰, Rosa Serrano-Morales¹¹, Maria Constanza Bertolaccini¹², Eduardo Kerzberg¹³, Maria Angeles Gargiulo¹⁴, Anabella Rodriguez¹⁵, Vitalina Barbosa¹⁶, Andres gasparin¹⁷, Fernando Cavalcanti¹⁸, Laissa Alves Alvino¹⁹, Luciana Parente Costa Seguro²⁰, Lucas Victoria de Oliveira Martins²¹, oscar Niera²², Loreto Massardo²³, Gustavo Aroca Martinez²⁴, Ivana Nieto Aristizabal²⁵, Paul Mendez Patarroyo²⁶, Antonio iglesias Gamarra²⁴, Andres Zuniga Vera²⁷, Olga-Lidia Vera-Lastra²⁸, Mario Perez Cristobal²⁹, Eduardo Martin-Nares³⁰, Luis M Amezcua-Guerra³¹, Yelitza Gonzalez-Bello³², Octavio Gonzalez Enriquez³³, Dionico Galarzo-Delgado³⁴, Carolina Vazquez³⁵, Marcelo barrios³⁶, Magaly Alba Linares³⁷, Cristina Reategui³⁸, Ana Quiroz-Alva³⁹, Teresandris Polanco Mora⁴⁰, Carina Pizzarossa⁴¹, Martin Rebella⁴², Maria Crespo⁴³, Alvaro Danza⁴⁴, Eloisa Silva Dutra de Oliveira Bonfa⁴⁵, Graciela Alarcón⁴⁶, Federico Zazzetti⁴⁷, Ashley Orillion⁴⁸, Guillermo Pons-Estel⁴⁹ and Urbano Sbarigia^{50 1}GO-CREAR, Rosario, Santa Fe, Argentina, ²Grupo Oroño - Centro Regional de Enfermedades Autoinmunes y Reumáticas (GO-CREAR), Rosario, Santa Fe, Argentina, ³Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil, ⁴Instituto de Investigaciones Teóricas y Aplicadas. Facultad de Ciencias Económicas y Estadistica. Universidad Nacional de Rosario, Rosario, Argentina, ⁵Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁶Hospital Italiano de Córdoba, Córdoba, Argentina, ⁷Rheumatology Unit, Internal Medicine Service, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁸Hospital Privado Universitario de Córdoba, Cordoba, Argentina, ⁹Hospital HIGA San Martín, San Martín, Argentina, ¹⁰Sanatorio Británico, Rosario, Argentina, ¹¹Sanatorio Parque. Centro de Enfermedades Autoinmunes y Reumáticas del Grupo Oroño, Rosario, Argentina, ¹²Hospital Padilla, San Miguel de Tucuman, Argentina, ¹³Hospital General de Agudos Dr. Ramos Mejia, Buenos Aires, Argentina, ¹⁴Instituto de Investigaciones Médicas Alfredo Lanari, Buenos Aires, Argentina, ¹⁵CEMIC, Galvan, Argentina, ¹⁶Universidade Federal de Goiás, Goiana, Brazil, ¹⁷Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil, ¹⁸Universidad Federal de Pernambuco, Recife, Brazil, ¹⁹Hospital Universitario Pedro Ernesto, UERJ, Rio de Janiero, Brazil, ²⁰Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil, ²¹Universidad Federal São Paulo, São Paulo, Brazil, ²²Hospital del Salvador, Providencia, Chile, ²³Universidad San Sebastián, Santiago de Chile, Chile, ²⁴Clínica de la Costa Ltda., Barranquilla, Colombia, ²⁵Fundación Valle del Lili, Calí, Colombia, ²⁶Fundación Santa Fe, Bogotá, Colombia, ²⁷Hospital Luis Vernaza, Guayaquil, Ecuador, ²⁸Centro Médico La Raza, Ciudad de México, Mexico, ²⁹Centro Médico Nacional Siglo XXI, Ciudad de México, Mexico, ³⁰Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, Mexico, ³¹Instituto Nacional de Cardiología Ignacio Chávez, Ciudad de México, Mexico, ³²Centro de Estudios de investigación Básica y Clínica S.C, Jalisco, Mexico, ³³Hospital Central Dr. Ignacio Morones Prieto, San Luis, Mexico, ³⁴Hospital Universitario "Dr. José Eleuterio Gonzalez", Monterrey, Mexico, ³⁵Hospital de Clínicas I, Montevideo, Uruguay, ³⁶Hospital de Clínicas II, Montevideo, Uruguay, ³⁷Hospital Nacional Edgardo Rebagliatti Martins, Lima, Peru, ³⁸Hospital Nacional Guillermo Almenara Irigoyen. EsSalud, Lima, Peru, ³⁹Hospital Cayetano Heredia, San Martín de Porres District, Peru, ⁴⁰Hospital Docente Padre Billini, Santo Domingo, Dominican Republic, ⁴¹Clínica Médica C, Hospital de Clínicas, UDELAR, Montevideo, Uruguay, ⁴²Departamento de Medicina, Facultad de Medicina, Universidad de la República, Montevideo, Uruguay, ⁴³Hospital Señor del Milagro, Salta, Argentina, ⁴⁴Grupo de Investigacion de EAIS y Reumatológicas, A Coruña, Spain, ⁴⁵Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil, ⁴⁶The University of Alabama at Birmingham, Oakland, ⁴⁷Janssen Medical Affairs Global Services, LLC, Buenos Aires, Argentina, ⁴⁸Janssen, Horsham, PA, ⁴⁹CREAR, Rosario, Argentina, ⁵⁰Johnson & Johnson, Beerse, Belgium

Background/Purpose: Clinically evident kidney disease eventually occurs in up to one-half of SLE patients. The aim of this study is to describe sociodemographic, clinical, serological and treatment characteristics of a multicenter and multiethnic Latin American SLE cohort (GLADEL 2.0. Grupo Latino Americano De Estudio del Lupus) of patients with or without lupus nephritis (LN).

Methods: The GLADEL 2.0 is an observational prevalent and incident cohort initiated in 2019. Forty-four centers from 10 Latin-American countries enrolled patients ≥18 years who fulfilled 1982/1997 American College of Rheumatology (ACR) classification criteria for SLE. Patients of this cohort were categorized into four different subsets: Group I: Without renal involvement (never); Group II: With prevalent renal involvement. currently inactive; Group III: With prevalent renal involvement. currently active. and Group IV: With incident renal (onset < 3 months) involvement with renal biopsy. Demographic, clinical manifestations, treatments, disease activity (SLEDAI- 2k) and SLICC/ACR Damage Index (SDI) were examined at baseline. A descriptive cross-sectional analysis of data collected from May 2019 to May 2022 was performed. Numeric variables are reported as medians (interquartile ranges IQR) and compared using Kruskall-Wallis test; categorical variables are reported as frequencies (percentages) and compared using Chi-square or Fisher tests, as appropriate.

Results: A total of 991 SLE patients were included. 884 (89.2%) were female. Median (IQR) age at cohort entry was 35 (28-45) years. Median disease duration was 67 months (18-139) and 656 (68.3%) were Mestizos (of Amerindian and European ancestry). Patients with incident LN (group IV) had a higher proportion of males, were younger at diagnosis, had a shorter disease duration and were more frequently Mestizos (Table 1). Clinical, serological, treatment, disease activity and damage among groups are noted in Table 2, and revealed that for group I pericarditis and anti-dsDNA were less frequent and MMF was less often used by group I and IV. Table 3 shows the renal characteristics of the 510 patients (349 patients with prevalent LN from group II and III and 161 incident LN patients from Group IV) who underwent a kidney biopsy with a clear predominance of Class IV.

Conclusion: Baseline characteristics of the GLADEL 2.0 well characterized lupus patients’ cohort with or without LN are described with distinct demographic, clinical and laboratory patterns that will allow both centralized laboratory evaluation of urinary biomarkers and exploratory biomarker analyses including transcriptome and their impact on the outcome of these patients.
Table 1: GLADEL 2.0 Sociodemographic Characteristics

Table 2: Clinical characteristics, disease activity, damage index and treatment at cohort entry.

Table 3: Renal characteristics of patients with LN proven by renal biopsy.
Disclosures: R. Nieto, None; R. Quintana, None; e. Borba, None; L. Hernandez, None; D. Fernandez-Avila, None; L. Maurelli, None; P. Alba, Pfizer, AbbVie/Abbott, Elea Phoenix, International League of Associations of Rheumatology; F. Bordon, None; F. Arizpe, None; G. Berbotta, None; R. Serrano-Morales, Pfizer, AbbVie/Abbott, Elea Phoenix, International League of Associations of Rheumatology; M. Bertolaccini, None; E. Kerzberg, None; M. Angeles Gargiulo, None; A. Rodriguez, None; V. Barbosa, None; A. gasparin, None; F. Cavalcanti, None; L. Alves Alvino, None; L. Parente Costa Seguro, None; L. Victoria de Oliveira Martins, None; o. Niera, None; L. Massardo, None; G. Aroca Martinez, None; I. Nieto Aristizabal, None; P. Mendez Patarroyo, None; A. iglesias Gamarra, None; A. Zuniga Vera, None; O. Vera-Lastra, None; M. Perez Cristobal, None; E. Martin-Nares, None; L. Amezcua-Guerra, None; Y. Gonzalez-Bello, None; O. Gonzalez Enriquez, None; D. Galarzo-Delgado, None; C. Vazquez, None; M. barrios, None; M. Alba Linares, None; C. Reategui, Janssen; A. Quiroz-Alva, None; T. Polanco Mora, None; C. Pizzarossa, None; M. Rebella, AbbVie, Bayer, Pfizer, Roche; M. Crespo, None; A. Danza, None; E. Silva Dutra de Oliveira Bonfa, None; G. Alarcón, None; F. Zazzetti, Janssen Medical Affairs Global Services, LLC; A. Orillion, Janssen; G. Pons-Estel, Janssen, GSK, Pfizer, Werfen/Inova, Novartis; U. Sbarigia, Janssen.