Early treatment with rituximab in newly diagnosed systemic lupus erythematosus patients: a steroid-sparing regimen

Rheumatology (Oxford). 2012 Mar;51(3):476-81. doi: 10.1093/rheumatology/ker337. Epub 2011 Nov 16.

Abstract

Objectives: To assess the effectiveness of B-cell depletion therapy (BCDT) as a steroid-sparing treatment in newly diagnosed SLE patients.

Methods: Eight female SLE patients were treated with BCDT using a rituximab/CYC-based regimen aiming to avoid the routine use of oral steroids. Post-treatment, patients were given AZA. The BILAG disease activity index was used for clinical assessment. Serum anti-dsDNA, complement (C3), ESR, circulating B lymphocytes (CD19(+)) and protein : creatinine ratio were tested at 0, 1, 3, 6 and 12 months post-treatment. Disease activity and steroid requirement over the first 6 months of treatment were compared with three SLE patients treated conventionally, each carefully matched for ethnicity, sex, age at disease onset and disease duration at diagnosis.

Results: All patients achieved B-cell depletion (CD19 count <0.005 × 10(9)/l). The mean decrease in global BILAG at 6 months for the BCDT patients was -12.0 vs 13.22 for the controls. Post-BCDT, no patient developed any significant deterioration, mean ESR fell from 70.12 to 17.14 mm/h at 6 months, mean serum anti-dsDNA antibody levels fell by >70% at 1 month and serum C3 level normalized in two patients by 6 months. There were no adverse events. The mean cumulative prednisolone dose at 6 months for the BCDT patients was 1287.3 mg (range 250-4501.8 mg) vs 2834.6 mg (range 0-6802.5 mg) for the controls.

Conclusion: Early treatment of SLE patients with BCDT is safe and effective and enables a reduction in the overall steroid burden.

Publication types

  • Comparative Study

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Antibodies, Anti-Idiotypic / blood
  • Antibodies, Monoclonal, Murine-Derived / administration & dosage*
  • Antibodies, Monoclonal, Murine-Derived / adverse effects
  • Antirheumatic Agents / administration & dosage*
  • Antirheumatic Agents / adverse effects
  • Azathioprine / administration & dosage
  • B-Lymphocytes / cytology*
  • B-Lymphocytes / drug effects
  • Blood Sedimentation
  • Case-Control Studies
  • Complement C3 / metabolism
  • Cyclophosphamide / administration & dosage*
  • Cyclophosphamide / adverse effects
  • DNA / blood
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Lupus Erythematosus, Systemic / diagnosis
  • Lupus Erythematosus, Systemic / drug therapy*
  • Lymphocyte Depletion
  • Middle Aged
  • Prednisolone / administration & dosage
  • Rituximab
  • Severity of Illness Index
  • Treatment Outcome
  • Young Adult

Substances

  • Adrenal Cortex Hormones
  • Antibodies, Anti-Idiotypic
  • Antibodies, Monoclonal, Murine-Derived
  • Antirheumatic Agents
  • Complement C3
  • Rituximab
  • Cyclophosphamide
  • DNA
  • Prednisolone
  • Azathioprine