Table 3. Percentage change from baseline in absolute lymphocyte counts at day 28 following treatment with CDP323 for 28 days (per protocol population).
| Lymphocyte type | Treatment groupa | Mean change from baseline, %b | Mean change vs placebo,% (99% CI)c | P value |
| Total lymphocytes (CD45+) | Linear trend test | <0.0001 | ||
| Quadratic trend test | 0.0669 | |||
| Placebo | 12.1 | – | – | |
| CDP323 100 mg bid | 8.1 | −4.0 (−28.7, 20.6) | 0.6678 | |
| CDP323 500 mg bid | 43.7 | 31.6 (6.9, 56.3) | 0.0012 | |
| CDP323 1000 mg qd | 39.7 | 27.6 (2.9, 52.3) | 0.0042 | |
| CDP323 1000 mg bid | 46.2 | 34.2 (9.5, 58.8) | 0.0005 | |
| Naive B cells (CD19+/CD20+) | Linear trend test | <0.0001 | ||
| Quadratic trend test | 0.7857 | |||
| Placebo | 33.2 | – | – | |
| CDP323 100 mg bid | 13.0 | −20.3 (−78.9, 38.4) | 0.3637 | |
| CDP323 500 mg bid | 74.8 | 41.6 (−17.1, 100.3) | 0.0650 | |
| CDP323 1000 mg qd | 69.4 | 36.1 (−22.8, 95.0) | 0.1091 | |
| CDP323 1000 mg bid | 101.8 | 68.6 (9.9, 127.2) | 0.0028 | |
| Memory B cells | Linear trend test | <0.0001 | ||
| (CD19+/CD20+/CD27+) | Quadratic trend test | 0.1080 | ||
| Placebo | 31.6 | – | – | |
| CDP323 100 mg bid | 18.2 | −13.4 (−87.1, 60.3) | 0.6343 | |
| CDP323 500 mg bid | 138.0 | 106.4 (33.2, 179.7) | 0.0002 | |
| CDP323 1000 mg qd | 126.3 | 94.7 (21.3, 168.2) | 0.0010 | |
| CDP323 1000 mg bid | 166.8 | 135.2 (62.3, 208.1) | <0.0001 | |
| T cells (CD3+) | Linear trend test | 0.0019 | ||
| Quadratic trend test | 0.0542 | |||
| Placebo | 15.5 | – | – | |
| CDP323 100 mg bid | 9.1 | −6.4 (−33.1, 20.3) | 0.5277 | |
| CDP323 500 mg bid | 41.4 | 25.9 (−0.9, 52.7) | 0.0128 | |
| CDP323 1000 mg qd | 41.1 | 25.6 (−1.3, 52.4) | 0.0140 | |
| CDP323 1000 mg bid | 38.4 | 22.9 (−3.8, 49.5) | 0.0261 | |
| NK T cells (CD3+/CD56+) | Linear trend test | 0.0900 | ||
| Quadratic trend test | 0.0146 | |||
| Placebo | 13.3 | – | – | |
| CDP323 100 mg bid | 14.8 | 1.5 (−31.3, 34.3) | 0.9043 | |
| CDP323 500 mg bid | 50.1 | 36.8 (4.1, 69.5) | 0.0039 | |
| CDP323 1000 mg qd | 36.6 | 23.2 (−10.0, 56.5) | 0.0693 | |
| CDP323 1000 mg bid | 28.8 | 15.5 (−17.3, 48.3) | 0.2171 | |
| NK cells (CD3+/CD56+) | Linear trend test | <0.0001 | ||
| Quadratic trend test | 0.0836 | |||
| Placebo | 5.5 | – | – | |
| CDP323 100 mg bid | 23.5 | 18.0 (−9.0, 45.1) | 0.0836 | |
| CDP323 500 mg bid | 47.6 | 42.1 (14.9, 69.2) | <0.0001 | |
| CDP323 1000 mg qd | 40.5 | 35.0 (7.8, 62.2) | 0.0010 | |
| CDP323 1000 mg bid | 57.7 | 52.2 (25.2, 79.2) | <0.0001 | |
| Monocytes (CD14+) | Linear trend test | 0.0991 | ||
| Quadratic trend test | 0.8544 | |||
| Placebo | 21.5 | – | – | |
| CDP323 100 mg bid | 8.0 | −13.5 (−54.3, 27.4) | NR | |
| CDP323 500 mg bid | 27.6 | 6.1 (−34.6, 46.8) | NR | |
| CDP323 1000 mg qd | 27.9 | 6.4 (−34.6, 47.3) | NR | |
| CDP323 1000 mg bid | 37.2 | 15.7 (−24.7, 56.1) | NR | |
| Hematopoietic | Linear trend test | 0.0592 | ||
| progenitor cells (CD34+) | Quadratic trend test | 0.2727 | ||
| Placebo | 18.6 | – | – | |
| CDP323 100 mg bid | 65.1 | 46.5 (−126.7, 219.6) | NR | |
| CDP323 500 mg bid | 185.7 | 167.1 (−11.5, 345.6) | NR | |
| CDP323 1000 mg qd | 75.4 | 56.8 (−110.6, 224.2) | NR | |
| CDP323 1000 mg bid | 140.4 | 121.8 (−39.7, 283.2) | NR |
a
n = 14 per group except for CD34+ cells, where n = 5 for placebo and CDP323 1000 mg bid and n = 4 for CDP323 100 mg bid, CDP323 500 mg bid, and CDP323 1000 mg qd.
b
Least squares mean from analysis of variance (ANOVA).
c
Statistical comparisons were made using univariate ANOVA.
bid = twice daily; CI = confidence interval; NK = natural killer; NR = not reported (linear trend test for dose-response relationship was not statistically significant); qd = once daily.
Note: For all lymphocyte types, differences between the 500-mg bid and 1000-mg qd dosages were not statistically significant and are not displayed in this table.