Table 2.
Outcome to induction therapy after course 1 according to PBC response and randomization arm
| All patients | CR patients* | NR patients | ED patients | P† | |
|---|---|---|---|---|---|
| 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.