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

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 x 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.