Table 4.
Summary of changes from baseline in peripheral CD20+ B cells (cells μl–1) (study A)*
| Study day | Placebo n = 7 | 0.01 mg kg –1 n = 3 | 0.04 mg kg –1 n = 2 | 0.125 mg kg –1 n = 6 | 0.5 mg kg –1 n = 3 | 2.0 mg kg –1 n = 5 | 8.0 mg kg –1 n = 3 | P value † |
|---|---|---|---|---|---|---|---|---|
| Day 8 | −28.19 (−96.75, 40.38) | 104.72 (0.39, 209.05) | 186.56 (58.96, 314.16) | 81.22 (7.36, 155.09) | 135.06 (30.04, 240.08) | 65.83 (−17.15, 148.82) | 72.59 (−31.82, 177.00) | 0.047 |
| Day 22 | −46.47 (−115.03, 22.09) | −17.95 (−122.28, 86.38) | −5.44 (−133.04, 122.16) | −71.94 (−145.80, 1.92) | 63.72 (−41.30, 168.74) | −99.77 (−182.75, −16.78) | 56.59 (−47.82, 161.00) | 0.139 |
| Day 43 | −54.19 (−122.75, 14.38) | 35.05 (−69.28, 139.38) | −20.94 (−148.54, 106.66) | −12.61 (−86.47, 61.25) | 71.39 (−33.63, 176.41) | −118.81 (−207.63, −30.00) | 2.26 (−102.15, 106.67) | 0.140 |
| Day 64 | −45.71 (−117.92, 26.51) | −6.28 (−110.61, 98.05) | 5.06 (−122.54, 132.66) | −41.53 (−120.10, 37.03) | 5.39 (−99.63, 110.41) | −173.17 (−256.15, −90.18) | −28.74 (−133.15, 75.67) | 0.096 |
| Day 127 | −13.97 (−86.07, 58.13) | −36.28 (−140.61, 68.05) | −18.44 (−146.04, 109.16) | −14.48 (−109.34, 80.37) | –‡ | −220.77 (−303.75, −137.78) | −76.41 (−180.82, 28.00) | 0.006 |
| Day 190 | −10.04 (−78.61, 58.52) | −96.61 (−200.95, 7.72) | −18.44 (−146.04, 109.16) | −9.94 (−83.80, 63.92) | −72.28 (−177.30, 32.74) | −222.17 (−305.15, −139.18) | −111.07 (−215.48, −6.67) | 0.005 |
| Day 253 | −82.95 (−234.67, 68.78) | −179.19 (−299.11, −59.26) | –‡ | −15.18 (−110.04, 79.69) | −60.28 (−165.30, 44.74) | −157.57 (−240.55, −74.58) | −182.16 (−302.09,‐62.22) | 0.120 |
*
There was no difference in the change in the number of peripheral CD20+ B cells between RA and SLE subjects. Consequently, the data from both populations were combined. Values represent LS mean (95% confidence interval). Negative change indicates a reduction in B‐cell counts.
†
Overall F test.
‡
No useable samples were available for this time point.