Table 4.

Summary of pharmacodynamic measures: CD19+ B cells (median and median percentage change from baseline).

Ofatumumab
MeasuresPlacebo, n = 80.3 mg, n = 43 mg, n = 630 mg, n = 860 mg, n = 6100 mg, n = 3
Mean baselinea (GI/l)0.2010.1780.1720.2130.3410.234
Day 1 predose, n846752
Median day 1 predose (GI/l)0.1410.1440.15450.2020.3150.182
Day 29, n836842
Median % change3.206−48.322−73.147−98.828−99.024−98.418
Minimum % change−96.95−63.31−97.02−99.27−99.39−98.99
Maximum % change39.94−29.57−2.99−82.96−97.18−97.84
Patients achieving target depletion
No. achieving target depletion (%)1 (13)b01 (17)7 (88)6 (100)3 (100)
No. achieving target depletion who started to replete (%)1 (100)01 (100)4 (57)6 (100)3 (100)
Median time in days to start of repletion from target depletion (range)4304372.5 (43–112)99 (57–341)85 (56–112)
Median time in days to repletion from target depletion (range)430337590 (253–657)266.5 (113–607)280 (170–421)
  • aBaseline is Day 1 predose value or the screening value if the Day 1 predose is missing.

  • bPlacebo patient had unexplained target depletion at Day 29 and met repletion criterion at Day 43.