Table 1.
Incidence of TE infection by NK cell count, weeks 0–24a
| Placebo (n = 860) | Baricitinib 2 mg/day (n = 393) | Baricitinib 4 mg/day (n = 868) | |
|---|---|---|---|
| Never‐low NK cell count, no. (%)b | 718 (83.5) | 316 (80.4) | 618 (71.2)c |
| Patients with ≥1 TE infection | 213 (29.7) | 114 (36.1)d | 217 (35.1)d |
| Patients with ≥1 TE herpes zoster | 3 (0.4) | 3 (0.9) | 13 (2.1)e |
| Patients with ≥1 serious infection | 13 (1.8) | 4 (1.3) | 10 (1.6) |
| Low NK cell count, no. (%)f | 142 (16.5) | 77 (19.6) | 250 (28.8)c |
| Patients with ≥1 TE infection | 47 (33.1) | 29 (37.7) | 112 (44.8)d |
| Patients with ≥1 TE herpes zoster | 0 | 1 (1.3) | 2 (0.8) |
| Patients with ≥1 serious infection | 1 (0.7) | 1 (1.3) | 3 (1.2) |
a
Data are from the time of treatment initiation through 24 weeks, with data censored at rescue. TE = treatment‐emergent.
b
Patients who never experienced low natural killer (NK) cell values (defined as values <95 cells/μl) at any time postbaseline up to time of rescue.
c
P ≤ 0.001 versus baricitinib 2 mg/day and versus placebo, by Fisher's exact test.
d
P ≤ 0.05 versus placebo.
e
P ≤ 0.01 versus placebo.
f
Patients who experienced ≥1 low NK cell value at any time postbaseline up to the time of rescue.