{
  "abstract": "Introduction Accurate assessment of disease activity in SLE is crucial but challenging due to its varied clinical manifestations and severity. Current tools like the SLE Disease Activity Index (SLEDAI) have limitations, including unvalidated cut-off points, low sensitivity to certain severe features and an overemphasis on serological markers. There is a need for improved definitions of disease activity.Methods We analysed data from 1463 patients with SLE in the prospective, multicentre RELESSER-PROS cohort (39 Spanish hospitals) over five annual visits. A panel of lupus experts used the Delphi method to develop new definitions for moderate disease activity state (MODAS) and severe disease activity state (SEDAS). These incorporated clinical SLEDAI (cSLEDAI), selected severe non-SLEDAI manifestations (eg, neuropsychiatric involvement, proteinuria, severe haematological features) and the Physician Global Assessment. We compared the predictive performance of MODAS/SEDAS with SLEDAI for mortality, organ damage, severe flares, hospitalisations and health-related quality of life, using receiver operating characteristics curves.Results At baseline, 20% of patients met MODAS criteria and 24.6% SEDAS criteria, versus 10.5% and 3.0%, respectively, by SLEDAI. MODAS/SEDAS reclassified 19.9% of patients considered mild by SLEDAI, and 53.3% of moderate cases. MODAS/SEDAS showed modest but consistent improvement in predictive accuracy for damage (area under the curve 0.570 vs 0.550), flares (0.609 vs 0.564) and hospitalisations (0.609 vs 0.565). These definitions were associated with worse outcomes and demonstrated a dose–response relationship, although the overall predictive ability remained moderate.Conclusion MODAS and SEDAS offer an alternative framework for defining moderate and severe SLE activity, with modest but consistent improvements in predictive performance compared with SLEDAI. By integrating cSLEDAI, key severe features and physician judgement, they improve prognostic performance and support a severity-based approach to clinical management and research. Their clinical utility remains preliminary, and further external validation is required before routine implementation.",
  "authors": [
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario San Roque, Las Palmas de Gran Canaria, Spain",
        "Rheumatology and Inmuno-Mediated Diseases Research Group (IRIDIS), Galicia Sur Health Research Institute, Vigo, Spain"
      ],
      "name": "Irene Altabás-González"
    },
    {
      "affiliations": [
        "Rheumatology, Complejo Hospitalario Doctor Negrin, Las Palmas de Gran Canaria, Spain"
      ],
      "name": "Iñigo Rua-Figueroa"
    },
    {
      "affiliations": [
        "Rheumatology, Instituto de Investigación Galicia Sur, External Statistical Advisor, Rosario, Argentina"
      ],
      "name": "Karen Roberts"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Galicia Sur Health Research Institute, Vigo, Spain",
        "Complexo Hospitalario Universitario de Vigo, Vigo, Spain"
      ],
      "name": "Ivonne Lourdes Mamani"
    },
    {
      "affiliations": [
        "Rheumatology, Vigo University Hospital Group, Vigo, Spain"
      ],
      "name": "Coral Mouriño"
    },
    {
      "affiliations": [
        "Hospital General Universitario Gregorio Marañón, Madrid, Spain"
      ],
      "name": "Julia Martinez-Barrio"
    },
    {
      "affiliations": [
        "Hospital Universitario Doce de Octubre, Madrid, Spain"
      ],
      "name": "Maria Galindo Izquierdo"
    },
    {
      "affiliations": [
        "Hospital Universitario Araba, Vitoria-Gasteiz, Spain"
      ],
      "name": "Jaime Calvo-Alén"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Insulsar Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria, Spain"
      ],
      "name": "Celia Erausquin"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain"
      ],
      "name": "Belén Serrano-Benavente"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario de Donostia, San Sebastián, Spain"
      ],
      "name": "Esther Uriarte"
    },
    {
      "affiliations": [
        "Rheumatology Department, Hospital Universitario de la Princesa, Madrid, Spain"
      ],
      "name": "Eva Tomero"
    },
    {
      "affiliations": [
        "Rheumatology, University Hospital Complex of A Coruña, A Coruña, Spain"
      ],
      "name": "Mercedes Freire-González"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain"
      ],
      "name": "Ricardo Blanco"
    },
    {
      "affiliations": [
        "Rheumatology, Complejo Hospitalario de Orense, Ourense, Spain"
      ],
      "name": "Eva Salgado"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital General Universitario de Alicante, Alicante, Spain"
      ],
      "name": "Silvia Gómez-Sabater"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Regional Universitario de Malaga, Málaga, Spain"
      ],
      "name": "Antonio Fernandez-Nebro"
    },
    {
      "affiliations": [
        "Rheumatology, Severo Ochoa University Hospital, Leganes, Spain"
      ],
      "name": "Clara Sangüesa"
    },
    {
      "affiliations": [
        "Rheumatology Department, Bellvitge University Hospital, L’Hospitalet de Llobregat, Spain"
      ],
      "name": "Javier Narvaez"
    },
    {
      "affiliations": [
        "Reumatología, UGC de Reumatología, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain"
      ],
      "name": "Natalia Mena Vázquez"
    },
    {
      "affiliations": [
        "Rheumatology Service, Jerez de la Frontera University Hospital, Jerez de la Frontera, Spain"
      ],
      "name": "Raúl Menor-Almagro"
    },
    {
      "affiliations": [
        "Rheumatology, Marina Baixa Hospital, Alicante, Spain"
      ],
      "name": "José Carlos Rosas Gómez de Salazar"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Sierrallana, Torrelavega, Spain"
      ],
      "name": "Elena Aurrecoechea"
    },
    {
      "affiliations": [
        "Rheumatology Department, Basurto University Hospital, Bilbao, Spain"
      ],
      "name": "Oihane Ibarguengoitia-Barrena"
    },
    {
      "affiliations": [
        "Hospital Universitario de Salamanca, Salamanca, Spain"
      ],
      "name": "Carlos Montilla"
    },
    {
      "affiliations": [
        "Rheumatology, La Paz University Hospital, Madrid, Spain"
      ],
      "name": "Gema Bonilla"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Hospital de Sant Joan Despí Moises Broggi, Sant Joan Despí, Spain"
      ],
      "name": "Vicente Torrente Segarra"
    },
    {
      "affiliations": [
        "Rheumatology Department, Hospital Son Llàtzer, Palma de Mallorca, Spain"
      ],
      "name": "Antonio Juan-Mas"
    },
    {
      "affiliations": [
        "Hospital Universitario Ramon y Cajal, Madrid, Spain"
      ],
      "name": "María Jesús García-Villanueva"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Hospital de León, León, Spain"
      ],
      "name": "Claudia Moriano Morales"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital de Navarra, Pamplona, Spain"
      ],
      "name": "Loreto Horcada"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Virgen de la Arrixaca, Murcia, Spain"
      ],
      "name": "Nuria Lozano-Rivas"
    },
    {
      "affiliations": [
        "University Hospital Lucus Augusti, Lugo, Spain"
      ],
      "name": "Carlota Iñiguez"
    },
    {
      "affiliations": [
        "Consorci Corporació Sanitària Parc Taulí, Sabadell, Spain"
      ],
      "name": "Marta Arevalo"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Infanta Sofia, San Sebastian de los Reyes, Madrid, Spain"
      ],
      "name": "Beatriz Paredes"
    },
    {
      "affiliations": [
        "Hospital Universitario de Canarias, San Cristóbal de La Laguna, Spain"
      ],
      "name": "Lorena Exposito"
    },
    {
      "affiliations": [
        "Rheumatology, Hospital Virgen Macarena, Sevilla, Spain"
      ],
      "name": "Francisco J Toyos"
    },
    {
      "affiliations": [
        "Rheumatology Department, Hospital Universitario Doctor Peset, Valencia, Spain"
      ],
      "name": "Eduardo Flores-Fernandez"
    },
    {
      "affiliations": [
        "Rheumatology, Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas GC, Spain"
      ],
      "name": "Javier Nóvoa Medina"
    },
    {
      "affiliations": [
        "Rheumatology, La Fe University and Polytechnic Hospital, Valencia, Spain"
      ],
      "name": "Jorge Juan Fragio Gil"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Hospital Universitario Príncipe de Asturias, Alcala de Henares, Spain"
      ],
      "name": "Cristina Bohórquez"
    },
    {
      "affiliations": [
        "Rheumatology, Inst Invest Biomed Vigo Spain, Vigo, Spain"
      ],
      "name": "J M Pego-Reigosa"
    }
  ],
  "title": "Validation of proposals for definitions of moderate and severe disease activity in SLE: impact on flares, quality of life, damage accrual, hospitalisations and mortality",
  "uid": "262dd463-a480-5975-aee2-bbcb36880afa"
}