The effects of rituximab and obinutuzumab on lymphocyte subsets in peripheral blood and lymphoid tissues of SLE patients

Systemic lupus erythematodes

the proportion of patients with depletion of total CD19+ B cells in the peripheral blood (quantitative using highly-sensitivity flow cytometry) and lymph nodes, defined as a decrease of >2 points on a 4-point semi-quantitative scale. These will be separate co-primary endpoints. We will statistically test the difference in the proportions of patients with depletion by these criteria in RTX- versus OBI-treated patients,

Correlation between CD19+ lymphocyte (and other B lineage cells) depletion in peripheral blood/tissues and clinical response. Depletion (defined as a decrease of >2 points on a 4-point semi-quantitative scale of CD19+ cells in the lymph node) will be related to clinical response (defined as a >4 point improvement in cSLEDAI or any improvement in BILAG-2004 score) in a 2x2 chi-square test for all 20 patients. Changes in B lineage cells and associated T cell subsets in lymph nodes and skin of SLE

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Netherlands