Table 3.
Changes from baseline in T cell subsets and Ki67 and Bcl-2 expression.
| Treatment | P-value Week 24 |
||||
|---|---|---|---|---|---|
| LDMTX (N=54) | Placebo (N=64) | LDMTX (N=54) | Placebo (N=64) | ||
| Week 0 | Week 0 | Δ to Week 24 | Δ to Week 24 | ||
| CD4 T cells | |||||
| Ki67+ | 3.10 (2.30, 4.10) | 3.00 (2.50, 3.65) | -0.55 (-1.10, 0.10) | 0.10 (-0.45, -0.65) | <0.001 |
| Bcl-2+ | 92.8 (90.3, 95.0) | 92.3 (89.9, 94.4) | 1.40 (0.30, 2.30) | -0.35 (-1.10, 0.60) | <0.001 |
| Ki67+Bcl-2+ | 1.45 (1.00, 1.90) | 1.25 (1.00, 1.60) | -0.05 (-0.40, 0.20) | 0.00 (-0.20, 0.25) | 0.47 |
| Ki67+Bcl-2- | 1.70 (1.30, 2.10) | 1.75 (1.30, 2.25) | -0.50 (-0.80, -0.10) | 0.10 (-0.20, 0.45) | <0.001 |
| Naïve (CD45RA+CD27+) | 41.5 (32.1, 53.2) | 39.9 (28.0, 54.3) | 1.30 (-0.80, 3.70) | 1.00 (-1.05, 3.65) | 0.62 |
| …. Ki67+ | 0.56 (0.35, 0.69) | 0.50 (0.36, 0.64) | -0.03 (-0.12, 0.06) | 0.02 (0.10, 0.15) | 0.20 |
| …. Bcl-2+ | 97.2 (95.6, 98.2) | 96.4 (94.2, 98.1) | 0.31 (-0.31, 0.62) | -0.16 (-1.11, 0.34) | <0.001 |
| …. Ki67+Bcl-2+ | 0.40 (0.26, 0.57) | 0.32 (0.26, 0.47) | 0.01 (-0.08, 0.09) | 0.01 (-0.07, 0.08) | 0.87 |
| …. Ki67+Bcl-2- | 0.12 (0.08, 0.18) | 0.13 (0.09, 0.19) | -0.03 (-0.08, 0.01) | 0.01 (-0.02, 0.05) | 0.003 |
| TEMRA (CD45RA+CD27-) | 1.10 (0.30, 2.80) | 1.55 (0.60, 4.65) | 0.05 (-0.20, 0.20) | 0.00 (-0.40, 0.40) | 0.41 |
| …. Ki67+ | 3.40 (2.38, 5.31) | 2.86 (1.89, 4.84) | -0.59 (-1.42, 0.23) | 0.56 (-0.49, 1.80) | <0.001 |
| …. Bcl-2+ | 94.0 (88.2, 96.1) | 93.2 (88.3, 95.7) | 2.71 (1.40, 4.78) | -0.45 (-2.59, 1.68) | <0.001 |
| …. Ki67+Bcl-2+ | 1.88 (1.38, 2.73) | 1.54 (1.04, 2.43) | 0.25 (-0.55, 0.84) | 0.36 (-0.32, 0.97) | 0.47 |
| …. Ki67+Bcl-2- | 1.36 (0.63, 2.95) | 1.17 (0.71, 2.16) | -0.69 (-1.34, -0.30) | 0.17 (-0.28, 0.68) | <0.001 |
| TCM (CD45RA-CD27+) | 45.0 (39.1, 55.3) | 46.0 (36.4, 56.3) | -0.35 (-3.60, 1.50) | -0.55 (-3.95, 0.90) | 0.91 |
| …. Ki67+ | 4.83 (3.91, 6.13) | 4.59 (4.02, 5.78) | -0.68 (-1.63, 0.15) | 0.21 (-0.84, 1.26) | 0.002 |
| …. Bcl-2+ | 90.2 (88.1, 91.9) | 89.2 (86.2, 91.4) | 2.03 (0.46, 3.61) | -0.46 (-1.83, 0.70) | <0.001 |
| …. Ki67+Bcl-2+ | 2.08 (1.47, 2.82) | 1.81 (1.45, 2.44) | -0.14 (-0.61, 0.24) | 0.03 (-0.38, 0.39) | 0.23 |
| …. Ki67+Bcl-2- | 2.95 (2.28, 3.66) | 2.79 (2.47, 3.39) | -0.63 (-1.28, 0.11) | 0.09 (-0.41, 0.73) | <0.001 |
| TEM (CD45RA-CD27-) | 6.85 (4.80, 13.8) | 8.80 (4.95, 12.1) | -0.60 (-1.30, 0.20) | -0.40 (-1.25, 0.40) | 0.67 |
| …. Ki67+ | 6.59 (5.09, 10.3) | 6.47 (4.64, 8.10) | -1.40 (-2.93, 0.04) | 0.55 (-1.21, 2.19) | <0.001 |
| …. Bcl-2+ | 89.4 (84.8, 91.3) | 88.1 (83.6, 91.4) | 4.54 (1.61, 6.73) | -0.10 (-3.41, 1.82) | <0.001 |
| …. Ki67+Bcl-2+ | 3.00 (2.11, 3.91) | 2.42 (1.74, 3.31) | 0.09 (-0.65, 0.62) | 0.16 (-0.55, 0.59) | 0.78 |
| …. Ki67+Bcl-2- | 3.76 (2.85, 6.16) | 3.76 (2.56, 4.79) | -1.73 (-2.89, -0.55) | 0.31 (-0.66, 1.45) | <0.001 |
| CD8 T cells | |||||
| Ki67+ | 2.30 (1.70, 2.70) | 1.95 (1.55, 2.50) | -0.50 (-1.00, -0.20) | 0.10 (-0.30, 0.50) | <0.001 |
| Bcl-2+ | 91.9 (89.2, 93.7) | 89.8 (86.4, 93.7) | 2.75 (1.70, 4.70) | -0.15 (-2.00, 1.55) | <0.001 |
| Ki67+Bcl-2+ | 1.10 (0.80, 1.50) | 1.00 (0.70, 1.30) | 0.00 (-0.30, 0.20) | 0.00 (-0.15, 0.30) | 0.49 |
| Ki67+Bcl-2- | 1.00 (0.70, 1.30) | 0.80 (0.65, 1.30) | -0.60 (-0.90, -0.30) | 0.10 (-0.20, 0.20) | <0.001 |
| Naïve (CD45RA+CD27+) | 19.5 (14.6, 27.9) | 21.6 (16.8, 28.7) | 0.75 (-0.20, 2.80) | 0.30 (-1.40, 2.90) | 0.31 |
| …. Ki67+ | 0.42 (0.28, 0.57) | 0.41 (0.27, 0.60) | -0.06 (-0.12, 0.08) | 0.00 (-0.07, 0.14) | 0.029 |
| …. Bcl-2+ | 96.1 (94.0, 97.3) | 95.0 (91.3, 97.2) | 0.86 (-0.18, 1.91) | 0.22 (-0.81, 1.11) | 0.027 |
| …. Ki67+Bcl-2+ | 0.29 (0.18, 0.40) | 0.28 (0.19, 0.41) | 0.01 (-0.05, 0.10) | 0.01 (-0.04, 0.07) | 0.92 |
| …. Ki67+Bcl-2- | 0.10 (0.07, 0.18) | 0.11 (0.07, 0.18) | -0.05 (-0.09, -0.02) | 0.00 (-0.05, 0.06) | <0.001 |
| TEMRA (CD45RA+CD27-) | 25.6 (17.3, 36.8) | 26.1 (15.1, 36.3) | 0.15 (-3.30, 2.10) | -1.00 (-3.75, 2.65) | 0.77 |
| …. Ki67+ | 2.07 (1.51, 2.82) | 1.95 (1.57, 2.32) | -0.13 (-0.65, 0.47) | 0.15 (-0.39, 0.65) | 0.12 |
| …. Bcl-2+ | 92.6 (89.8, 95.0) | 91.5 (86.9, 94.1) | 2.19 (1.11, 3.87) | -0.25 (-2.78, 1.81) | <0.001 |
| …. Ki67+Bcl-2+ | 1.41 (1.07, 2.04) | 1.24 (0.93, 1.60) | 0.17 (-0.26, 0.66) | 0.14 (-0.34, 0.42) | 0.28 |
| …. Ki67+Bcl-2- | 0.59 (0.43, 0.84) | 0.55 (0.37, 0.91) | -0.30 (-0.48, -0.10) | 0.05 (-0.13, 0.24) | <0.001 |
| TCM (CD45RA-CD27+) | 34.6 (27.2, 42.9) | 33.3 (21.8, 42.6) | -0.60 (-2.70, 2.00) | -0.45 (-4.95, 2.50) | 0.55 |
| …. Ki67+ | 2.25 (1.73, 3.24) | 2.23 (1.52, 3.05) | -0.76 (-1.31, -0.16) | 0.13 (-0.18, 0.62) | <0.001 |
| …. Bcl-2+ | 90.0 (86.0, 92.7) | 87.3 (83.5, 81.2) | 3.34 (1.82, 5.42) | 0.34 (-2.04, 1.77) | <0.001 |
| …. Ki67+Bcl-2+ | 0.94 (0.64, 1.40) | 0.84 (0.61, 1.18) | -0.08 (-0.28, 0.14) | 0.03 (-0.17, 0.22) | 0.09 |
| …. Ki67+Bcl-2- | 1.28 (0.86, 1.86) | 1.20 (0.85, 1.89) | -0.71 (-1.08, -0.29) | 0.10 (-0.13, 0.43) | <0.001 |
| TEM (CD45RA-CD27-) | 12.4 (9.00, 18.2) | 13.2 (8.75, 18.9) | -0.90 (-1.80, 1.20) | 0.50 (-0.90, 1.85) | 0.018 |
| …. Ki67+ | 4.16 (3.36, 6.54) | 4.20 (2.96, 5.40) | -1.35 (-2.69, -0.57) | -0.01 (-0.77, 1.08) | <0.001 |
| …. Bcl-2+ | 88.7 (84.1, 90.7) | 87.0 (82.0, 90.7) | 4.34 (2.85, 7.49) | 0.17 (-2.09, 2.27) | <0.001 |
| …. Ki67+Bcl-2+ | 2.05 (1.66, 2.94) | 1.62 (1.26, 2.72) | -0.03 (-0.52, 0.45) | 0.03 (-0.52, 0.61) | 0.51 |
| …. Ki67+Bcl-2- | 2.22 (1.57, 3.38) | 2.17 (1.44, 3.21) | -1.35 (-2.26, -0.82) | 0.06 (-0.52, 0.55) | <0.001 |
TCM, central memory T cells; TEM, effector memory T cells; TEMRA, effector memory T cells that have reacquired CD45RA expression.
Bold values show P-values that are statistically significant (<0.05).