Figure 4.
Changes in B-cell parameters. (A) Mean naïve B-cell percentages (CD19+CD27-CD10-) over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, 20, 19, 19, and 16; placebo, 10, 9, 9, and 10. (B) Mean transitional B-cell percentages (CD19+CD27-CD10+) over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, 19, 20, 20, and 17; placebo, 10, 8, 9, and 9. (C) Mean plasmablast percentage (CD19+CD27+CD38++) over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, 20, 20, 19, and 16; and placebo, 10, 9, 9, and 10. (D) Mean serum IgM level over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, 21, 20, 21, and 21; and placebo, 10, 10, 10, and 10. (E) Mean switched (CD19+CD27+IgD-) and nonswitched (CD19+CD27+IgD+) memory B-cell percentages over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, switched, 20, 19, 19, and 16; placebo, switched, 10, 8, 9, and 10; leniolisib, nonswitched, 20, 19, 20, and 17; and placebo, nonswitched, 10, 9, 9, and 10. Baseline was calculated as the average of D−1 and D1. All patients from the safety analysis set with measurements are included in the figures, whereas efficacy analysis of (A) used the B-PD analysis set. Gray boxes indicate reference range from literature (A-C,E) or laboratory (D).27,29 In (E), gray box indicates reference range for switched memory B cells and dotted line indicates reference range for nonswitched memory B cells. Error bars are SEM.

Changes in B-cell parameters. (A) Mean naïve B-cell percentages (CD19+CD27-CD10-) over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, 20, 19, 19, and 16; placebo, 10, 9, 9, and 10. (B) Mean transitional B-cell percentages (CD19+CD27-CD10+) over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, 19, 20, 20, and 17; placebo, 10, 8, 9, and 9. (C) Mean plasmablast percentage (CD19+CD27+CD38++) over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, 20, 20, 19, and 16; and placebo, 10, 9, 9, and 10. (D) Mean serum IgM level over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, 21, 20, 21, and 21; and placebo, 10, 10, 10, and 10. (E) Mean switched (CD19+CD27+IgD-) and nonswitched (CD19+CD27+IgD+) memory B-cell percentages over time. n values for baseline, D29, D57, and D85 for each group are as follows: leniolisib, switched, 20, 19, 19, and 16; placebo, switched, 10, 8, 9, and 10; leniolisib, nonswitched, 20, 19, 20, and 17; and placebo, nonswitched, 10, 9, 9, and 10. Baseline was calculated as the average of D−1 and D1. All patients from the safety analysis set with measurements are included in the figures, whereas efficacy analysis of (A) used the B-PD analysis set. Gray boxes indicate reference range from literature (A-C,E) or laboratory (D).27,29 In (E), gray box indicates reference range for switched memory B cells and dotted line indicates reference range for nonswitched memory B cells. Error bars are SEM.

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