title: Clinical profile and direct medical cost of care of adults presenting with systemic lupus erythematosus in Italy.
abstract: OBJECTIVE
  To determine the clinical profile and estimate the annual direct medical cost of care of adult patients with active, autoantibody positive systemic lupus erythematosus (SLE) in Italy.
  
  
  METHODS
  A two-year, retrospective, multicentre, observational study was conducted from January to May 2011. Patients' characteristics, SLE disease activity and severity, rate of flares, healthcare consumption (e.g. medications, etc.) were evaluated. Medical costs were assessed from the Italian National Health Insurance perspective.
  
  
  RESULTS
  Four centres enrolled 96 eligible patients, including 85.4% women. Patients were equally stratified per disease severity (severe SLE: 51%). The mean (SD) age was 42.9 (13.8) years. At baseline, SLE duration was 12.6 (7.2) years. The mean (SD) SELENA-SLEDAI score was higher in severe than in non-severe patients 9.2 (6.4) vs. 3.3 (3.1) (p<0.001). The mean (SD) SLICC/ACR index score was similar in the two subgroups: 0.4 (0.8) vs. 0.3 (0.8). Over the study period, severe patients experienced on average 0.73 (0.56) flares/year and non-severe patients 0.57 (0.63). The annual medical cost was 1.6 times higher in severe than in non-severe patients (€2,101 vs. €1,320; p=0.031). The cost of medications was also 2.5 times higher in severe patients (€1101 vs. €445, p=0.007). Low C3/C4 complement levels and each severe flare incremented the annual cost of €550 (p=0.011) and €465 (p=0.02), respectively.
  
  
  CONCLUSIONS
  The medical cost of SLE in Italy is related to disease severity and flares. Medications identified as the main cost drivers, and low C3/C4 complement levels and severe flares as the main cost predictors, increased significantly the cost of SLE management.
authors.affiliation: Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Doria
authors.affiliation: Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Iaccarino
authors.affiliation: Rheumatology Unit, Second University of Napoli, Napoli, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: La Montagna
authors.affiliation: Division of Rheumatology, Department of Medical Sciences, University of Cagliari, Cagliari, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Mathieu
authors.affiliation: Division of Rheumatology, Department of Medical Sciences, University of Cagliari, Cagliari, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Piga
authors.affiliation: Department of Rheumatology, Ospedale Santa Maria alle Scotte, University of Siena, Siena, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Galeazzi
authors.affiliation: Department of Rheumatology, Ospedale Santa Maria alle Scotte, University of Siena, Siena, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Iuliano
authors.affiliation: HEOR, Real-World Evidence Solutions (RWES) unit, IMS Health, Paris-La Défense, France.
authors.forename: Frédérique B
authors.initials: FB
authors.lastname: Maurel
authors.affiliation: HEOR, Real-World Evidence Solutions (RWES) unit, IMS Health, Paris-La Défense, France.
authors.forename: Anna M
authors.initials: AM
authors.lastname: Garofano
authors.affiliation: Immuno-Inflammation & Infectious Diseases (II-ID) Global Franchise, GlaxoSmithKline, London, UK.
authors.forename: Alessandra G
authors.initials: AG
authors.lastname: Perna
authors.affiliation: Speciality Care Medical Department, GlaxoSmithKline, Verona, Italy.
authors.forename: Rolando E
authors.initials: RE
authors.lastname: Porcasi
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care / Q000191:economics; D001323:Autoantibodies / Q000097:blood; D015415:Biomarkers / Q000097:blood; D016527:Drug Costs; D004632:Emergency Medical Services / Q000191:economics; D005260:Female; D017721:Hospital Costs; D006760:Hospitalization / Q000191:economics; D006801:Humans; D007166:Immunosuppressive Agents / Q000191:economics* / Q000627:therapeutic use*; D007558:Italy / Q000453:epidemiology; D008180:Lupus Erythematosus, Systemic / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009819:Office Visits / Q000191:economics; D012008:Recurrence; D012074:Remission Induction; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001323:Autoantibodies; D015415:Biomarkers; D007166:Immunosuppressive Agents