Objective: To evaluate efficacy, serological responses, and predictors of response in patients with severe and refractory systemic lupus erythematosus (SLE) treated with rituximab (RTX) plus cyclophosphamide (CYC).
Methods: Sixteen patients entered a treatment protocol using RTX plus CYC. Disease activity was assessed by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and by British Isles Lupus Assessment Group (BILAG) index.
Results: At 6 months follow-up, mean SLEDAI values decreased significantly from 12.1(±2.2) to 4.7(±1.1). Clinical improvement (50% reduction in SLEDAI) occurred in all but 3 patients. All but 1 patient responded according to BILAG. Remission defined as SLEDAI<3 was achieved in 9/16 patients. Isotype analysis of anti-dsDNA antibodies revealed preferential decreases of IgG and IgA, but not IgM. Higher absolute numbers of CD19+ cells at baseline were correlated with shorter depletion time (r=-0.6).
Conclusion: The majority of patients improved following RTX plus CYC. The differential downregulation of anti-DNA of the IgG and IgA but not the IgM isotypes supports the hypothesis that cells producing pathogenic autoantibodies are preferentially targeted by the treatment. The fact that higher absolute numbers of CD19+ cells at baseline predict a less impressive clinical and serological response suggests that more flexible dosing could be advantageous.
- Systemic Lupus Erythematosus
- clinical trial
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