Per-protocol predefined population, people with RRMS treated with 14 mg of teriflunomide. Peripheral blood mononuclear cells (PBMCs) isolated and analyzed by flow cytometry at baseline and 6 months. Data are represented as mean (SD) or median (IQR). Change from baseline represented as least squares means (LSM) change (SEM) or median (IQR). P values from linear mixed model analysis of month 6 with baseline. N/A, not applicable
Lymphocytes | CD4+ T cells | CD8+ T cells | CD19+ B cells | Ratio CD4/CD8 | |
Absolute counts (cells/μl) | |||||
Baseline Month 6 Δ from baseline P value | 1882.8 (651) 1587.9 (451) −284.94 (47.3) <0.001 | 1036.1 (449.7) 913.9 (383.6) −101.14 (30.91) 0.002 | 154.3 (97.7; 203.9) 118.4 (67.5; 233.9) −34.7 (−55.5;−5.3) 0.005 | N/A | N/A |
Lymphocytes (% PBMC) | CD4+ T cells (% CD3+ cells) | CD8+ T cells (% CD3+ cells) | CD19+ B cells (% lymphocytes) | Ratio CD4/CD8 | |
Frequencies | |||||
Baseline Month 6 Δ from baseline P value | 79.5 (9.1) 76.7 (11.3) −3.05 (1.43) 0.040 | 82.9 (74.9; 88.2) 85.3 (79.1; 91.2) 1.6 (−0.5; 3.7) 0.006 | 12.5 (8.9; 18.6) 10.9 (6.7; 16.9) −1.0 (−3.5; 0.4) 0.009 | 10.6 (7.7; 14.9) 7.7 (6.4; 11.8) −2.0 (−4.1; 0) 0.001 | 6.8 (4.2; 9.9) 7.8 (4.8; 12.8) 0.6 (−0.2; 3.9) 0.008 |