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Remission and Low Disease Activity Status (LDAS) protect lupus patients from damage occurrence: data from a multiethnic, multinational Latin American Lupus Cohort (GLADEL)
  1. Manuel Francisco Ugarte-Gil1,2,
  2. Daniel Wojdyla3,
  3. Guillermo J Pons-Estel4,5,
  4. Luis J Catoggio6,7,
  5. Cristina Drenkard8,
  6. Judith Sarano9,
  7. Guillermo A Berbotto10,
  8. Eduardo F Borba11,
  9. Emilia Inoue Sato12,
  10. João C Tavares Brenol13,
  11. Oscar Uribe14,
  12. Luis A Ramirez Gómez14,
  13. Marlene Guibert-Toledano15,
  14. Loreto Massardo16,
  15. Mario H Cardiel17,
  16. Luis H Silveira18,
  17. Rosa Chacón-Diaz19,
  18. Graciela S Alarcón20,
  19. Bernardo A Pons-Estel5
  20. on behalf of GLADEL
  1. 1Department of Rheumatology, Hospital Guillermo Almenara Irigoyen, Lima, Peru
  2. 2Universidad Científica del Sur, Lima, Peru
  3. 3GLADEL consultant, Rosario, Argentina
  4. 4Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Spain
  5. 5Centro Regional de Enfermedades Autoinmunes y Reumáticas (CREAR), Rosario, Argentina
  6. 6Sección de Reumatología, Servicio de Clínica Médica, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
  7. 7Instituto Universitario, Escuela de Medicina Hospital Italiano and Fundación Dr Pedro M. Catoggio para el Progreso de la Reumatología, Buenos Aires, Argentina
  8. 8Department of Medicine, Division of Rheumatology, Emory School of Medicine, Atlanta, Georgia, USA
  9. 9Servicio de Inmunología, Instituto de Investigaciones Médicas Alfredo Lanari, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
  10. 10Servicio de Reumatología, Hospital Escuela “Eva Perón”, Granadero Baigorria, Argentina
  11. 11Division of Rheumatology, Faculdade de Medicina, Hospital das Clínicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil
  12. 12Disciplina de Reumatologia, Escola Paulista de Medicina/UNIFESP, Hospital São Paulo, Universidade Federal de São Paulo, São Paulo, Brazil
  13. 13Division of Rheumatology, Department of Internal Medicine, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
  14. 14Grupo de Reumatología, Facultad de Medicina, Universidad de Antioquia, Hospital Universitario “San Vicente Fundacion”, Medellín, Colombia
  15. 15Servicio de Reumatología, Centro de Investigaciones Médico Quirúrgicas, La Habana, Cuba
  16. 16Facultad de Medicina, Universidad San Sebastián, Santiago, Chile
  17. 17Centro de Investigación Clínica de Morelia, Michoacán, Mexico
  18. 18Departamento de Reumatología, Instituto Nacional de Cardiología “Ignacio Chávez”, Mexico Distrito Federal, Mexico
  19. 19Servicio de Reumatología, Centro Nacional de Enfermedades Reumáticas, Hospital Universitario de Caracas, Caracas, Venezuela
  20. 20Department of Medicine, Division of Clinical Immunology and Rheumatology, School of Medicine, The University of Alabama, Birmingham, Alabama, USA
  1. Correspondence to Manuel Francisco Ugarte-Gil, Department of Rheumatology, Hospital Guillermo Almenara Irigoyen, Lima 33, Perú; manuel_ugarte{at}yahoo.com

Abstract

Objective To evaluate disease activity statuses’ (DAS’) impact on systemic lupus erythematosus (SLE) outcomes.

Materials and methods Four DAS were defined: remission off-therapy: SLE Disease Activity Index (SLEDAI)=0, no prednisone or immunosuppressive drugs (IS); remission on-therapy: SLEDAI=0, prednisone ≤5 mg/day and/or IS (maintenance); low (L) DAS: SLEDAI ≤4, prednisone ≤7.5 mg/day and/or IS (maintenance); non-optimally controlled: SLEDAI >4 and/or prednisone >7.5 mg/day and/or IS (induction). Antimalarials were allowed in all. Predefined outcomes were mortality, new damage (increase of at least one Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) damage index (SDI) point) and severe new damage (increase of at least 3 SDI points). Univariable and multivariable Cox regression models were performed to define the impact of DAS, as time-dependent variable, on these outcomes.

Results 1350 patients were included, 79 died during follow-up, 606 presented new and 177 severe new damage. In multivariable analyses, remission (on/off-therapy) was associated with a lower risk of new (HR 0.60; 95% CI 0.43 to 0.85), and of severe new damage (HR 0.32; 95% CI 0.15 to 0.68); low disease activity status (LDAS) was associated with a lower risk of new damage (HR 0.66; 95% CI 0.48 to 0.93) compared with non-optimally controlled. No significant effect on mortality was observed.

Conclusions Remission was associated with a lower risk of new and severe new damage; LDAS with a lower risk of new damage after adjusting for other damage confounders.

  • systemic lupus erythematosus
  • remission
  • low disease activity status
  • disease damage
  • outcome

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Footnotes

  • Handling editor Tore K Kvien

  • Contributors All authors were involved in drafting or critically revising this manuscript for important intellectual content, and all authors approved the final version to be published. MFU-G, DW, GSA and BAP-E have full access to all the study’s data and take responsibility for their integrity and the accuracy of the analyses performed.

  • Competing interests None declared.

  • Ethics approval The study was performed according with the Declaration of Helsinki for the conduct of research in humans and following local institutional review board’s regulations.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Collaborators In addition to the authors, the following participants are members of the GLADEL Study Group and have incorporated at least 20 patients into the database with adequate follow-up. ARGENTINA: Enrique R Soriano, María Flavia Ceballos Recalde and Edson Velozo (Sección de Reumatología, Servicio de Clínica Médica; Hospital Italiano and Fundación Dr Pedro M Catoggio para el Progreso de la Reumatología, Buenos Aires,); Jorge A Manni, and Sebastián Grimaudo (Instituto de Investigaciones Médicas “Alfredo Lanari,” Buenos Aires); Emilce Schneeberger, María S Arriola and Graciela Gómez (Instituto de Rehabilitación Psicofísica, Buenos Aires); Mercedes A García, Ana Inés Marcos and Juan Carlos Marcos(Deceased) (Hospital Interzonal General de Agudos “General San Martín”, La Plata); Hugo R Scherbarth, Jorge A López and Estela L Motta (Hospital Interzonal General de Agudos “Dr Oscar Alende”, Mar del Plata); Susana Gamron, Laura Onetti and Sandra Buliubasich (Hospital Nacional de Clínicas, Córdoba); Verónica Saurit, Francisco Caeiro and Alejandro Alvarellos (Servicio de Reumatología, Hospital Privado, Centro Medico de Córdoba, Córdoba); Silvana Gentiletti(Deceased), Norberto Quagliatto, Alberto A Gentiletti and Daniel Machado(Deceased) (Hospital Provincial de Rosario, Rosario); Marcelo Abdala and Simón Palatnik(Deceased) (Hospital Provincial del Centenario, Universidad Nacional de Rosario, Rosario); Carlos A. Battagliotti(Deceased) (Hospital Escuela “Eva Perón”, Granadero Baigorria). BRASIL: Eloisa Bonfa (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo); Alexandre Wagner S Souza (Disciplina de Reumatología, Escola Paulista de Medicina, Universidade Federal da São Paulo -UNIFESP, São Paulo); Lilian T Lavras Costallat, Manoel Barros Bertolo and Ibsen Bellini Coimbra (Faculdade de Ciências Médicas, Universidade Estadual de Campinas, Campinas); Ricardo Xavier and Tamara Mucenic (Hospital das Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre); Fernando de Souza Cavalcanti, Ângela Luzia Branco Duarte and Claudia Diniz Lopes Marques (Centro de Ciências da Saúde, Universidade Federal de Pernambuco, Pernambuco); Nilzio Antonio da Silva, Ana Carolina de O e Silva and Tatiana Ferracine Pacheco (Faculdade de Medicina, Universidade Federal de Goiás, Goiânia). COLOMBIA: José Fernando Molina-Restrepo, Javier Molina-López and Gloria Vásquez (Universidad de Antioquia, Hospital Universitario “San Vicente de Paul,” Medellín); Antonio Iglesias-Rodríguez (Universidad del Bosque, Bogotá), Eduardo Egea-Bermejo (Universidad del Norte, Barranquilla); Antonio Iglesias-Gamarra, Renato A Guzmán-Moreno and José F Restrepo-Suárez (Clínica Saludcoop 104 Jorge Piñeros Corpas and Hospital San Juan de Dios, Universidad Nacional de Colombia, Bogotá). CUBA: Gil Reyes-Llerena and Alfredo Hernández-Martínez (Centro de Investigaciones Médico Quirúrgicas -CIMEQ, La Habana). CHILE: Sergio Jacobelli (Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago); Oscar Neira and Leonardo R Guzmán (Hospital del Salvador, Facultad de Medicina, Universidad de Chile, Santiago). GUATEMALA: Abraham García-Kutzbach, Claudia Castellanos and Erwin Cajas (Hospital Universitario Esperanza, Ciudad de Guatemala). MEXICO: Donato Alarcón-Segovia(Deceased), Virginia Pascual-Ramos and Antonio R Villa (Instituto Nacional de Ciencias Médicas y Nutrición “Salvador Zubirán,” Ciudad de Mexico); Mary Carmen Amigo (Reumatología, Centro Medico ABC, Ciudad de Mexico); Leonor A Barile (Hospital de Especialidades Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de Mexico), Ignacio García De La Torre, Gerardo Orozco-Barocio and Magali L. Estrada-Contreras (Hospital General de Occidente de la Secretaría de Salud, Guadalajara,); María Josefina Sauza del Pozo, Laura E. Aranda Baca and Adelfia Urenda Quezada (Instituto Mexicano de Seguro Social, Hospital de Especialidades Nº 25, Monterrey,); Guillermo F Huerta-Yáñez (Hospital de Especialidades Miguel Hidalgo, Aguascalientes). PERÚ: Eduardo M Acevedo-Vasquez, José Luis Alfaro-Lozano and Jorge M Cucho-Venegas (Hospital Nacional “Guillermo Almenara Irigoyen,” Essalud, Lima); María Inés Segami, Cecilia P Chung and Magaly Alva-Linares (Hospital Nacional “Edgardo Rebagliatti Martins,” Essalud, Lima). VENEZUELA: Isaac Abadi and Neriza Rangel (Servicio de Reumatología, Centro Nacional de Enfermedades Reumáticas, Hospital Universitario de Caracas, Caracas); María H Esteva-Spinetti and Jorge Vivas (Hospital Central de San Cristóbal, San Cristóbal).

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