title: The use of rituximab in newly diagnosed patients with systemic lupus erythematosus: long-term steroid saving capacity and clinical effectiveness.
abstract: BACKGROUND
  Previous reports indicate that treating patients with lupus (SLE) at or close to the time of diagnosis successfully without using any, or minimal, corticosteroids by using B-cell depletion (BCD) is possible in the short-term. It is not however known whether using BCD is as effective or reduces corticosteroid use in the long-term. We report the long-term (up to 7 years) use of BCD with respect to its steroid-saving capacity and clinical effectiveness in newly diagnosed SLE.
  
  
  METHODS
  Sixteen female patients with SLE were treated at, or shortly after diagnosis, with BCD therapy (BCDT) minimising the routine use of oral steroids. Post-treatment, most patients were given hydroxychloroquine (n=14) and azathioprine (n=10). The British Isles Lupus Assessment Group (BILAG) disease activity index was used for clinical assessment. Serum antidouble-stranded DNA (dsDNA) antibodies, complement (C3), erythrocyte sedimentation rate (ESR), circulating B lymphocytes (CD19+) and total inmmunoglobulins were tested every 2-6 months (average of 4.5 years) (SD 2) post-treatment. Disease activity and steroid requirement were compared with three patients with SLE treated conventionally, each matched for ethnicity, sex, age, clinical features, disease duration at diagnosis and follow-up period.
  
  
  RESULTS
  All patients given rituximab achieved BCD. The mean number of flares during follow-up (new BILAG A or B) was 2.63 (SD 3) in the BCDT group and 4 (SD 3.6) in the controls (NS, p=0.14). Post-BCDT, mean anti-dsDNA antibody level fell from 1114 U/mL (SD 1699.3) to 194 (SD 346.7) at 18 months (p=0.043), mean serum ESR fell by >70% at 6 months maintained during follow-up and serum C3 level normalised in 8 patients. The mean cumulative prednisolone dose at 60 months for the patients who underwent BCDT (n=11) was 4745.67 mg (SD 6090 mg) vs 12 553.92 mg (SD 12 672 mg) for the controls (p=0.01).
  
  
  CONCLUSIONS
  Early treatment of patients with SLE with BCDT is safe, effective and enables a reduction in steroid use.
authors.affiliation: Department of Internal Medicine , Lozano Blesa University Hospital , Zaragoza , Spain.
authors.forename: Borja
authors.initials: B
authors.lastname: Gracia-Tello
authors.affiliation: Centre for Rheumatology, University College London Hospitals , London , UK.
authors.forename: Amara
authors.initials: A
authors.lastname: Ezeonyeji
authors.affiliation: Centre for Rheumatology, University College London Hospitals , London , UK.
authors.forename: David
authors.initials: D
authors.lastname: Isenberg
keywords: B cells; DMARDs (biologic); Systemic Lupus Erythematosus