title: Etanercept in refractory lupus arthritis: An observational study.
abstract: OBJECTIVE
  To investigate the long-term safety and preliminary efficacy of etanercept in patients with refractory lupus arthritis.
  
  
  METHODS
  We evaluated 43 patients in this observational cohort study. All received etanercept (50mg/week) in addition to concomitant immunosuppressive agents. Patient and disease characteristics were collected. Incidence of adverse events and the effect on autoantibody levels were evaluated. Clinical efficacy was measured by the 28-joint count and the SLEDAI-2K scores. Remission of lupus arthritis was defined by a 28-joint score = 0. Clinically inactive systemic disease was defined by a SLEDAI-2K score <4.
  
  
  RESULTS
  The total follow-up time was 93 patient-years (median: 2.3 years per patient; range: 0.4-6.8 years). Most side effects were minor and related to local reactions. Only 2 significant adverse events occurred (8%), both were of infectious nature. The rate of autoantibody production was low (18%). A mild increase in titres of ANA (2), IgG anti-dsDNA (3) and IgM anticardiolipin (aCL) (2) antibodies was observed. All anti-dsDNA antibody increments were transient and coincided with systemic flares. No vascular events occurred. In general, disease activity declined during therapy. Most patients (83%) with lupus arthritis achieved clinical remission by week 12. All patients with simultaneous serositis experienced clinical and radiological resolution of this condition. Relapses were frequent (23%), mostly mild and related to etanercept reduction. A total of 24 patients discontinued treatment, 12 of them due to clinical remission.
  
  
  CONCLUSIONS
  Long-term therapy with etanercept was relatively safe and had remarkable long-term efficacy for refractory lupus arthritis. In view of these results, further controlled trials are warranted.
authors.affiliation: Systemic Autoimmune Diseases Unit, Internal Medicine Department, Universitari Vall d´Hebron Hospital, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Passeig Vall- d´Hebron 119-129, Barcelona 08035, Spain.
authors.forename: Josefina
authors.initials: J
authors.lastname: Cortés-Hernández
authors.affiliation: Systemic Autoimmune Diseases Unit, Internal Medicine Department, Universitari Vall d´Hebron Hospital, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Passeig Vall- d´Hebron 119-129, Barcelona 08035, Spain.
authors.forename: Natalia
authors.initials: N
authors.lastname: Egri
authors.affiliation: Systemic Autoimmune Diseases Unit, Internal Medicine Department, Universitari Vall d´Hebron Hospital, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Passeig Vall- d´Hebron 119-129, Barcelona 08035, Spain.
authors.forename: Miquel
authors.initials: M
authors.lastname: Vilardell-Tarrés
authors.affiliation: Systemic Autoimmune Diseases Unit, Internal Medicine Department, Universitari Vall d´Hebron Hospital, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Passeig Vall- d´Hebron 119-129, Barcelona 08035, Spain. Electronic address: jordi@vhebron.net.
authors.forename: Josep
authors.initials: J
authors.lastname: Ordi-Ros
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001168:Arthritis / Q000188:drug therapy* / Q000209:etiology / Q000276:immunology; D001323:Autoantibodies / Q000276:immunology; D015331:Cohort Studies; D000068800:Etanercept / Q000627:therapeutic use*; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007555:Isoxazoles / Q000627:therapeutic use; D000077339:Leflunomide; D008180:Lupus Erythematosus, Systemic / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D001323:Autoantibodies; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D007555:Isoxazoles; D006886:Hydroxychloroquine; D000077339:Leflunomide; D000068800:Etanercept; D008727:Methotrexate
keywords: Etanercept; Refractory arthritis; Systemic lupus erythematosus