Table 2.

Key Biomarker Results

PBOFEN 150 mg QDFEN 200 mg BID
Median (%) Change from Baseline at W48
 Plasmablast signature-19.7%
n=52
-54.3%*
n=53
-51.7%*
n=57
 CD19+ B cells (cells/µl)-0.50
n=38
-57.0*
n=49
-57.5*
n=48
 Anti-dsDNA# (IU/ml)+6.9
n=31
-38.3*
n=36
-75.7*
n=33
 Total IgG (g/L)-0.20
n=65
-1.25*
n=64
-1.56*
n=64
 C3 (g/L)-0.02
n=65
+0.01
n=67
-0.01
n=66
 C4 (g/L)0.00
n=65
+0.02*
n=67
+0.01*
n=66
  • #Patients who were positive at baseline (>30 IU/mL)

  • *Denotes significant vs. PBO; Kruskal-Wallis false-discovery rate controlled two sided (p-value ≤0.05)