Table 3.
Hematologic and serologic parameters Day -14 to end of treatment (EOT)
Patient # | White blood cells (× 109/l) RR 3.9-10.7 |
Absolute lymphocytes (× 109/l) RR 0.9-4.3 |
Absolute neutrophils (× 109/l) RR 2.0-7.2 |
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---|---|---|---|---|---|---|---|---|---|---|---|---|
Day -14 |
Day 1 | Day 14 (± 1) | EOT | Day -14 |
Day 1 | Day 14 (± 1) | EOT | Day -14 |
Day 1 | Day 14 (± 1) | EOT | |
2 | 11.2 | 6.0 | 8.3 | 3.8 | 1.7 | 1.6 | 1.7 | 2.0 | 8.9 | 4.1 | 6.4 | 1.6L1 |
8 | 6.3 | 15.1 | 12.4 | 8.1 | 0.8L2 | 0.9 | 1.3 | 1.0 | 5.0 | 13.7 | 10.6 | 7.0 |
3 | 5.7 | 11.1 | 8.1 | 4.7 | 0.9 | 0.7L2 | 0.5L2 | 0.2L3 | 4.4 | 10.1 | 7.4 | 4.3 |
5 | 2.8L2 | 15.6 | N/A | N/A | 1.0 | 3.4 | N/A | N/A | 1.6L1 | 10.6 | N/A | N/A |
13 | 14.7 | 5.6 | 8.5 | 7.6 | 1.5 | 0.7L2 | 0.5L3 | 0.7L2 | 13.1 | 4.7 | 7.8 | 6.5 |
14 | 15.5a | 15.2 | 8.3b | 7.1 | 0.9a | 1.8 | 0.8L1, b | 0.8L1 | 13.7a | 12.9 | 7.0b | 5.7 |
CD4+ (cells/μl) [%] RR 404-1612 [33-58] |
Complement C3 (g/l) RR 0.9-1.8 |
Anti-dsDNA (IU/ml) < 30.0, negative; 30-75, borderline; > 75, positive |
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Patient # | Day 1 | Day 28 (± 2) | EOT | Day 1 | Day 14 (± 1) | EOT |
Day -14 |
Day 1 | Day 14 (± 1) | EOT | ||
2 | 489 [25.8L] | 1731 [34.1] | 980 [44.6] | 0.686L | 0.904 | 0.721L | 917.2 | 375.7 | 168.1 | 463.9 | ||
8 | 277L2 [23.5L]c | 273L2 [29.7L] | 195L3 [24.0L] | 0.915 | 1.150 | 1.070 | 325.5 | 306.1 | 97.6 | 20.1 | ||
3 | N/A | 56L3 [13.7L] | 45L4 [21.4L] | 0.533L | 0.800L | 0.906 | 155.3 | 77.6 | 37.5 | < 12.3 | ||
5 | 529 [22.1L] | 809 [30.1L] | 603 [46.8] | 1.030 | 1.630 | 1.700 | 56.7 | 43.0 | 34.3 | 12.6 | ||
13 | 240L2 [38.7] | 95L3 [23.8L] | 163L3 [19.3L] | 0.462L | 0.717 | 0.909 | 87.5 | 26.0 | 13.0 | 12.7 | ||
14 | 135L3 [19.1L] | N/A | 158L3 [19.9L] | 0.434L | 0.541b | 0.609L | 349.6 | 88.1 | 28.8b | 20.1 |
Patients #2 and #8 randomized to placebo; Patients #3, #5, #13 and #14 randomized to atacicept 150 mg subcutaneously twice weekly (4 weeks), then 150 mg weekly (48 weeks). N/A, not available; RR, reference range. Values > ULN indicated in italics; LValues < LLN, with Grade (1 to 4), where applicable. aMeasured Day -10; bMeasured Day 18; cMeasured Day 4.