Validation of Proposals for Definitions of Moderate and Severe Disease Activity in Systemic Lupus Erythematosus, Based on Data Gathered from the RELESSER-PROS Register Database

Irene Altabás-González¹, Íñigo Rúa-Figueroa², Coral Mouriño³, Ivonne Lourdes Mamani⁴, Karen Roberts⁵, Julia Martínez-Barrio⁶, María Galindo-Izquierdo⁷, Jaime Calvo-Alen⁸, MARIA CELIA ERAUSQUIN ARRUABARRENA⁹, Belen Serrano-Benavente⁶, Irene Carrión-Barberà¹⁰, Esther Uriarte-Isacelaya¹¹, Eva Tomero Muriel¹², Mercedes Freire González¹³, Ricardo Blanco-Alonso¹⁴, Eva Salgado-Pérez¹⁵, Paloma Vela-Casasempere¹⁶, Antonio Fernández-Nebro¹⁷, Alejandro Olive¹⁸, Clara Sanguesa¹⁹, Javier Narvaez-García²⁰, Raúl Menor Almagro²¹, José Rosas-Gómez de Salazar²², José Ángel Hernández Beriain²³, Francisco j. Manero-Ruiz²⁴, Elena Aurrecoechea²⁵, Carlos Montilla²⁶, gema Bonilla²⁷, Oihane Ibarguengoitia Barrena²⁸, Vicenç Torrente-Segarra²⁹, Ana Paula Cacheda³⁰, María García-Villanueva³¹, Clara Moriano³², Loreto Horcada³³, Nuria Lozano-rivas³⁴, Cristina Bohorquez³⁵ and José María Pego-Reigosa³⁶, and RELESSER-Group, ¹Complejo Hospitalario de Vigo, Vigo, Galicia, Spain, ²Department of Rheumatology, Hospital Universitario Doctor Negrín, Las Palmas de Gran Canaria, Las Palmas GC, Spain, ³Complejo Hospitalario Universitario de Vigo. IRIDIS (Investigation in Rheumatology and Immune-Mediated Diseases) Group, Galicia Sur Health Research Institute, Vigo, Spain, ⁴COMPLEJO HOSPITALARIO UNIVERSITARIO DE VIGO, Pontevedra, Spain, ⁵Sección Reumatología, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁶Hospital Gregorio Marañón, Madrid, Spain, ⁷Hospital 12 de Octubre, Madrid, Madrid, Spain, ⁸Hospital Universitario de Araba, Araba, Spain, ⁹Gob Canarias, Tenerife, Canarias, Spain, ¹⁰Hospital del Mar, Barcelona, Spain, ¹¹Hospital Univeritario de Donostia, San Sebastián, Spain, ¹²La Princesa Hospital, Madrid, Madrid, Spain, ¹³Complexo Hospitalario Universitario de A Coruña, La coruna, Galicia, Spain, ¹⁴Division of Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Immunopathology group, Santander, Spain, ¹⁵Complejo Hospitalario de Orense, Ourense, Spain, ¹⁶Hospital General Universitario Alicante, Alicante, Spain, ¹⁷Department of Rheumatology, Hospital Universitario de Málaga, Málaga, Andalucia, Spain, ¹⁸Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain, ¹⁹Hospital Universitari Germans Trias i Pujol, Badalona, Spain, ²⁰Hospital Universitario de Bellvitge, Barcelona, Spain, ²¹Department of Rheumatology, Hospital Jerez de la Frontera, Jerez de la Frontera, Spain, ²²Hospital Marina Baixa, PALMA DE MALLORCA, Comunidad Valenciana, Spain, ²³Rheumatology Department. Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran C, Spain, ²⁴H. Miguel Servet, Zaragoza, Spain, ²⁵Hospital de Sierrallana, Torrelavega, Spain, ²⁶Hospital Universitario de Salamanca, Salamanca, Castilla y Leon, Spain, ²⁷Hospital Clínico Universitario La Paz, Madrid, Spain, ²⁸Rheumatology Division, Galdakao-Usansolo University Hospital, Galdako, Spain, ²⁹Hospital Comarcal Alt Penedès-Garraf, Vilafranca, Spain, ³⁰Hospital Universitario Son Llàtzer, Mallorca, Spain, ³¹Hospital Ramón y Cajal, MADRID, Madrid, Spain, ³²Hospital León, LEON, Spain, ³³Hospital Complex of Navarra, Pamplona, Spain, ³⁴Virgen de la Arrixaca University Hospital, Murcia, Spain, ³⁵Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid, Spain, ³⁶Galicia Health Service (SERGAS), Vigo, Spain

Meeting: ACR Convergence 2024

Keywords: autoimmune diseases, registry, Systemic lupus erythematosus (SLE)

Session Information

Date: Monday, November 18, 2024

Title: SLE – Diagnosis, Manifestations, & Outcomes Poster III

Session Type: Poster Session C

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

Background/Purpose: In systemic lupus erythematosus (SLE), there is not a standardized and validated definition of states of moderate and severe SLE activity. The aim of our study is to propose a definition for moderate disease activity state (MODAS) and severe disease activity state (SEDAS) in SLE and using the RELESSER-PROS cohort to describe the prevalence of both states and to analyze the impact of this categorization on different outcomes

Methods: The study population belongs to the RELESSER-PROS prospective cohort with data from patients followed annually for 4 years. The MODAS and SEDAS definitions were generated by a panel of lupus experts, which may be differentiated depending on absolute score of clinical Systemic Lupus Erythematosus Disease Activity Index (cSLEDAI), certain clinical manifestations not considered in SLEDAI and the subjective assessment of the physician, through PGA. MODAS was defined as the presence of at least one of the following conditions: < 4 cSLEDAI < 8 or 1< PGA < 2 (without severe clinical manifestations); and SEDAS: SLEDAIc >8 or PGA > 2 or the presence of severe SLEDAI and Non-SLEDAI manifestations. Low disease activity (No MODAS nor SEDAS): 1<SLEDAIc <4 or 0< PGA<1. Subsequently, an internal validation was carried out, analyzing the impact of belonging to one of the predefined groups in several robust outcomes overtime. For this purpose, the mortality, damage accrual (using the SLICC/ACR Damage Index [SDI]), number of severe flares (SFI definition), hospital admissions and HRQoL according to the Lupus Impact Tracker (LIT), were collected at each visit.

A descriptive analysis was conducted for the variables based on the presence of MODAS or SEDAS in at least 1 of the 5 visits and according to the number of visits with MODAS or SEDAS. The significance level for all tests was set at 0.05.

Results: A total of 1463 patients (90% women) were included, with a mean age (±SD) of 56 (±13.5) years. The mean disease duration of SLE (±SD) at V1 was 14 (±8.5) years.

Patients with at least 1 visit in MODAS or in SEDAS had significantly most damage accrual higher number of flares, more hospital admissions, and worse quality of life (p< 0.001). Damage accrual and hospital admissions were significantly higher in SEDAS than in MODAS. This is also the case for all the outcomes, except for mortality, when comparing being in MODAS or SEDAS with not being in these states. Figure 1. Besides, the more visits in MODAS or in SEDAS, greater damage, more admissions, more flares and worse quality of life. The SEDAS entails the greater risk of all the defined activity states. Table 1 and 2.

Conclusion: Patients who were in a state of moderate or severe activity at least one time had worse outcomes at the end of follow-up in terms of damage accrual, hospital admissions, number of flares and deterioration in HRQoL. Furthermore, more visits in these states entail a greater risk. The SEDAS is the one that is related to the worst outcomes. These results emphasize the importance of an adequate stratification of disease activity in SLE patients.

Disclosures: I. Altabás-González: AstraZeneca, 6, GlaxoSmithKlein(GSK), 6; Í. Rúa-Figueroa: AstraZeneca, 2, 6, GlaxoSmithKlein(GSK), 2, 6, Otsuka, 2, 6; C. Mouriño: None; I. Mamani: None; K. Roberts: None; J. Martínez-Barrio: None; M. Galindo-Izquierdo: None; J. Calvo-Alen: None; M. ERAUSQUIN ARRUABARRENA: None; B. Serrano-Benavente: None; I. Carrión-Barberà: AstraZeneca, 6, GlaxoSmithKlein(GSK), 6, Otsuka, 6; E. Uriarte-Isacelaya: None; E. Tomero Muriel: None; M. Freire González: None; R. Blanco-Alonso: AbbVie, 2, 5, 6, Bristol-Myers Squibb, 2, 6, Galapagos, 6, Janssen, 2, 6, Lilly, 2, 6, MSD, 2, 5, 6, Pfizer, 2, 6, Roche, 2, 5, 6; E. Salgado-Pérez: None; P. Vela-Casasempere: None; A. Fernández-Nebro: Argenx, 5, AstraZeneca, 2, 5, Chemo, 5, Eli Lilly, 2, Galapagos, 2, 5, Gebro Pharma, 2, GlaxoSmithKlein (GSK), 6, GSK, 2, Janssen, 5, Merck Serono, 5, MSD, 5, Novartis, 2, 5, Takeda, 5, UCB, 5; A. Olive: None; C. Sanguesa: None; J. Narvaez-García: None; R. Menor Almagro: None; J. Rosas-Gómez de Salazar: None; J. Hernández Beriain: None; F. Manero-Ruiz: None; E. Aurrecoechea: None; C. Montilla: None; g. Bonilla: None; O. Ibarguengoitia Barrena: None; V. Torrente-Segarra: None; A. Cacheda: None; M. García-Villanueva: None; C. Moriano: None; L. Horcada: None; N. Lozano-rivas: None; C. Bohorquez: None; J. Pego-Reigosa: AstraZeneca, 1, 6, GSK, 5, 6, Otsuka, 1, Pfizer, 5, Roche, 1.

To cite this abstract in AMA style:

Altabás-González I, Rúa-Figueroa Í, Mouriño C, Mamani I, Roberts K, Martínez-Barrio J, Galindo-Izquierdo M, Calvo-Alen J, ERAUSQUIN ARRUABARRENA M, Serrano-Benavente B, Carrión-Barberà I, Uriarte-Isacelaya E, Tomero Muriel E, Freire González M, Blanco-Alonso R, Salgado-Pérez E, Vela-Casasempere P, Fernández-Nebro A, Olive A, Sanguesa C, Narvaez-García J, Menor Almagro R, Rosas-Gómez de Salazar J, Hernández Beriain J, Manero-Ruiz F, Aurrecoechea E, Montilla C, Bonilla g, Ibarguengoitia Barrena O, Torrente-Segarra V, Cacheda A, García-Villanueva M, Moriano C, Horcada L, Lozano-rivas N, Bohorquez C, Pego-Reigosa J. Validation of Proposals for Definitions of Moderate and Severe Disease Activity in Systemic Lupus Erythematosus, Based on Data Gathered from the RELESSER-PROS Register Database [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/validation-of-proposals-for-definitions-of-moderate-and-severe-disease-activity-in-systemic-lupus-erythematosus-based-on-data-gathered-from-the-relesser-pros-register-database/. Accessed .

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