Table 2.

Outcome to induction therapy after course 1 according to PBC response and randomization arm

All patientsCR patients*NR patientsED patientsP
Patients, n (%) 151 (100.0) 108 (71.5) 34 (22.5) 9 (6.0)  
LAIP+cells/µL, median (range)      
 Day 1 4 198.2 (120.4-148 859.3) 4 502.2 (134.2-106 933.8) 2 853.12 (120.4-148 859.3) 1 496.8 (1 558-71 331.8) .24 
 Day 4 41.8 (0.1-44 802.3) 29.4 (0.1-11 035.5) 104.5 (0.2-44 802.3) 96.0 (1.8-627.8) .001 
PBC(log reduction)      
 Median (range) 1.9 (0.3-4.5) 2.3 (0.4-4.3) 1.0 (0.3-4.5) 1.4 (0.5-2.9) <.0001 
 PBChigh, n (%) 96 (63.6) 84 (77.8) 8 (23.5) 4 (44.4) <.0001 
 PBClow, n (%) 55 (36.4) 24 (22.2) 26 (76.5) 5 (55.6)  
PBC by randomization arm      
 ICE arm (n = 82)      
  Median (range) 1.8 (0.3-4.5) 2.2 (0.4-4.0) 1.0 (0.3-4.5) 1.4 (0.5-2.9) <.0001 
  PBChigh, n (%) 46 (56.1) 39 (78.0) 4 (16.0) 3 (14.3) <.0001 
  PBClow, n (%) 36 (43.9) 11 (22.0) 21 (84.0) 4 (85.7)  
 HDS arm (n = 69)      
  Median (range) 2 (0.6-4.2) 2.4 (0.6-4.2) 1.5 (0.7-2.5) 1.4 (1.0-1.9) .02 
  PBChigh, n (%) 50 (72.5) 45 (77.6) 4 (44.4) 1 (50.0) .05 
  PBClow, n (%) 19 (27.5) 13 (22.4) 5 (55.6) 1 (50.0)  
 P (HDS vs ICE arm) 0.04 0.72 0.08 0.89  
All patientsCR patients*NR patientsED patientsP
Patients, n (%) 151 (100.0) 108 (71.5) 34 (22.5) 9 (6.0)  
LAIP+cells/µL, median (range)      
 Day 1 4 198.2 (120.4-148 859.3) 4 502.2 (134.2-106 933.8) 2 853.12 (120.4-148 859.3) 1 496.8 (1 558-71 331.8) .24 
 Day 4 41.8 (0.1-44 802.3) 29.4 (0.1-11 035.5) 104.5 (0.2-44 802.3) 96.0 (1.8-627.8) .001 
PBC(log reduction)      
 Median (range) 1.9 (0.3-4.5) 2.3 (0.4-4.3) 1.0 (0.3-4.5) 1.4 (0.5-2.9) <.0001 
 PBChigh, n (%) 96 (63.6) 84 (77.8) 8 (23.5) 4 (44.4) <.0001 
 PBClow, n (%) 55 (36.4) 24 (22.2) 26 (76.5) 5 (55.6)  
PBC by randomization arm      
 ICE arm (n = 82)      
  Median (range) 1.8 (0.3-4.5) 2.2 (0.4-4.0) 1.0 (0.3-4.5) 1.4 (0.5-2.9) <.0001 
  PBChigh, n (%) 46 (56.1) 39 (78.0) 4 (16.0) 3 (14.3) <.0001 
  PBClow, n (%) 36 (43.9) 11 (22.0) 21 (84.0) 4 (85.7)  
 HDS arm (n = 69)      
  Median (range) 2 (0.6-4.2) 2.4 (0.6-4.2) 1.5 (0.7-2.5) 1.4 (1.0-1.9) .02 
  PBChigh, n (%) 50 (72.5) 45 (77.6) 4 (44.4) 1 (50.0) .05 
  PBClow, n (%) 19 (27.5) 13 (22.4) 5 (55.6) 1 (50.0)  
 P (HDS vs ICE arm) 0.04 0.72 0.08 0.89  
*

Number of CR patients in ICE arm (N = 82) vs HDS arm (N = 69): n = 50 (61%) vs n = 58 (84.1%) (P = .003).

Mann-Whitney U test or Kruskal-Wallis test was used for continuous variables; Pearson’s χ2 test was used for categorical variables.

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