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Table 4 Summary of B cell depletion activity of MEDI-551

From: Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study

MEDI-551 Dose Subjects, n Subjects achieving depletion,a n (%) Time to depletion,b,c median (range), days Duration of depletion,b,d median (range), days Maximum B cell reduction,e mean % (SD)
0.3 mg/kg 4 2 (50.0) 43.5 (30–57) 13.5 (0–27) 89.7 (3.9)
1.0 mg/kg 6 5 (83.3) 57.0 (29–67) 29.0 (0–209) 93.0 (10.2)
3.0 mg/kg 6 5 (83.3) 29.0 (7–85) 119 (0–154) 93.4 (10.9)
10.0 mg/kg 7 7 (100.0) 28.0 (3–86) 231 (30–264) 98.3 (3.2)
  1. aDefined as ≥ 90 % reduction in B cell counts from the day 1 value
  2. bAmong subjects who achieved B cell depletion
  3. cDefined as the time to the first observation of ≥90 % reduction from the day 1 value
  4. dDefined as the interval between the first and last observation of ≥90 % reduction in B cell count from the day 1 value. Subjects with B cell depletion at only a single assessment had a duration of depletion of zero
  5. eValues represent mean of the maximum degree of B cell reduction for subjects in the group, at any time after dosing, expressed as % reduction of day 1 values
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