Table 2.
Mixed linear model estimates of peripheral lymphocyte subsets after first ublituximab infusion.
| Lymphocyte subset | Model F (df)1 | p-valuea | ICC | Baseline Estimated mean (95% CI) | Day 180 Estimated mean (95% CI) | %Δ Baseline→day 180b | Post hoc: significant pairwise differences (mean difference* [95% CI], p-adj)** |
|---|---|---|---|---|---|---|---|
| CD3+ T cells |
6.25 (9, 72.1) |
<0.001 | 0.48 | 1,639 (1,289–1,990) |
1,452 (927–1,976) |
−11.6% | Baseline vs. day 0: 1,577 [823, 2,331], p < 0.001; all other pairwise comparisons: NS (p = 1.000) |
| CD3+CD8+ T cells |
8.09 (9, 71.2) |
<0.001 | 0.70 | 505 (427–583) |
450.6 (285–616) |
−10.8% | Baseline vs. day 0: −406 [−616, −196], p < 0.001; baseline vs. day 14: −189 [−369, −9], p = 0.03; baseline vs. day 30+: NS (p = 1.000) |
| CD4+CD4+ T cells |
6.89 (9, 71.9) |
<0.001 | 0.56 | 1,088 (828–1,348) |
956 (584–1,328) |
−12.1% | Baseline vs. day 0: −1,133 [−1,649.5, −617.2], ≥0.31 all other pairwise comparisons: NS (p ≥0.31) |
| CD19+ naive B cells |
19.8 (9, 63.9) |
<0.001 | 0.017 | 231 (200–262) |
0.1 (−56 to 56)c |
−100% | All post-baseline time points (0–180 days) vs. baseline: significant reduction (all p < 0.001); no differences among post-baseline (all p ≥ 0.99) |
| CD16+CD56+ NK cells | 2.64 (9, 71.7) |
0.011 | 0.49 | 274 (183–364) |
258 (123−392) |
−5.5% | Baseline vs. day 0: −239 [−432.4, −45.0], p = 0.004; day 0 vs. day 7: −230.2 [−427.3, −33.1], p = 0.008; all others NS (p ≥ 0.71) |
ICC, intraclass correlation coefficient; NS, not significant.
Model F (df): F statistic and degrees of freedom from the mixed-effects model.
%Δ expresses the relative percentage change in cell counts from baseline (day −3) to day 180. Negative values indicate a decrease; positive values indicate an increase.
Negative values in confidence intervals are statistical artifacts resulting from the estimation process and do not represent actual negative cell counts; these should be interpreted as indicating very low or undetectable levels.
*For post hoc pairwise comparisons, the mean difference is reported with its 95% CI and adjusted p-value. The sign of the mean difference indicates the direction of change: negative values mean the comparator group has a lower mean than the reference group, and positive values indicate a higher mean. These values reflect the actual differences between groups as estimated by the statistical model.
**Post hoc: Key significant pairwise differences from post hoc tests, with mean difference, 95% CI, and adjusted p-value.