Table 3.
Baseline circulating lymphocyte, cytokine and bone turnover markers (mITT population)
| Biomarkers | n | Cells/µL | Ratio (%) |
| Circulating lymphocyte profile: CD19+ B cells, mean (SD) | |||
| Naive B cells (IgD+CD27-) | 159 | 127.7 (122.4) | 55.2 (21.0) |
| Unswitched memory cells (IgD+CD27+) | 159 | 13.5 (12.0) | 9.8 (9.2) |
| Switched memory cells (IgD-CD27+) | 159 | 39.7 (37.2) | 22.6 (13.1) |
| Double-negative memory cells (IgD-CD27-) | 159 | 21.2 (24.2) | 11.8 (9.6) |
| Atypical activated memory cells (IgD-CD27-CD95+) | 159 | 6.4 (10.2) | 32.7 (18.2) |
| Circulating lymphocyte profile: CD3+ total T cells, mean (SD) | |||
| Helper T cells (CD4+CD8-) | 159 | 699.9 (415.1) | 46.2 (10.7) |
| Cytotoxic T cells (CD4-CD8+) | 159 | 436.1 (252.5) | 30.4 (10.1) |
| Double-negative T cells (CD4-CD8-) | 159 | 34.0 (44.7) | 2.5 (3.8) |
| Double-positive T cells (CD4+CD8+) | 159 | 12.6 (13.6) | 0.9 (0.7) |
| Circulating lymphocyte profile: CD4+Treg cells, mean (SD) | |||
| Naive Treg cells (CD25+ -FoxP3low- CD45RA+) | 136 | 63.0 (185.8) | 14.2 (11.2) |
| Effector Treg cells (CD25+ -FoxP3high- CD45RA-) | 136 | 58.6 (106.7) | 21.8 (13.5) |
| Non-suppressive cells (CD25+ -FoxP3low- CD45RA-) | 136 | 253.5 (501.4) | 61.0 (13.7) |
| Cytokines and bone turnover markers | n | pg/mL, ng/mL, µg/L |
| Cytokines, mean (SD) | ||
| IL-6 | 151 | 8.0 (16.1) pg/mL |
| IL-10 | 135 | 1.0 (1.0) pg/mL |
| IL-17 | 151 | 0.2 (0.3) pg/mL |
| Type I IFN-α | 157 | 13.7 (6.3) pg/mL |
| BAFF | 149 | 1401.2 (937.0) pg/mL |
| sVCAM-1 | 157 | 1004.2 (420.9) ng/mL |
| Bone turnover markers, mean (SD) | ||
| PINP | 160 | 45.8 (24.6) µg/L |
| CTX-I | 160 | 0.4 (0.2) µg/L |
BAFF, B-cell-activating factor; CTX-I, C-terminal crosslinking telopeptide of type I collagen; IFN, interferon; IL, interleukin; mITT, modified intent-to-treat; PINP, N-terminal propeptide of type I collagen; sVCAM, soluble vascular cell adhesion molecule; Treg, regulatory T.