Table 3.
Incidence rates (patients with event/100 patient‐years) for confirmed changes in laboratory parameters (P123LTE population)
| n (%) IR [95% CI] | Asia‐Pacific population | Global population | ||
|---|---|---|---|---|
|
Tofacitinib 5 mg BID N = 790 PY = 2491 |
Tofacitinib 10 mg BID N = 674 PY = 2283 |
All tofacitinib doses N = 1464 PY = 4773 |
All tofacitinib doses N = 6301 PY = 21 199 |
|
| Lymphocyte count <0.5 × 103/mm3 |
12 (1.5) 0.5 [0.3, 0.9] |
15 (2.2) 0.7 [0.4, 1.1] |
27 (1.8) 0.6 [0.4, 0.8] |
72 (1.1) 0.3 [0.3, 0.4] |
| Neutrophil count <0.5 × 103/mm3 |
0 (0.0) 0.0 [0.0, 0.2] |
0 (0.0) 0.0 [0.0, 0.2] |
0 (0.0) 0.0 [0.0, 0.1] |
0 (0.0) 0.0 [0.0, 0.0] |
| Decrease in hemoglobin ≥3 g/dL or hemoglobin level ≤7 g/dL |
5 (0.6) 0.2 [0.1, 0.5] |
4 (0.6) 0.2 [0.1, 0.5] |
9 (0.6) 0.2 [0.1, 0.4] |
90 (1.4) 0.4 [0.3, 0.5] |
| ALT increase >3 × ULN |
18 (2.3) 0.7 [0.4, 1.2] |
16 (2.4) 0.7 [0.4, 1.2] |
34 (2.3) 0.7 [0.5, 1.0] |
141 (2.2) 0.7 [0.6, 0.8] |
| AST increase >3 × ULN |
6 (0.8) 0.2 [0.1, 0.5] |
5 (0.7) 0.2 [0.1, 0.5] |
11 (0.8) 0.2 [0.1, 0.4] |
58 (0.9) 0.3 [0.2, 0.4] |
| Serum creatinine increase ≥50% from baseline |
35 (4.4) 1.4 [1.0, 2.0] |
26 (3.9) 1.2 [0.8, 1.7] |
61 (4.2) 1.3 [1.0, 1.7] |
319 (5.1) 1.6 [1.4, 1.7] |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; CI, confidence interval; LTE, long‐term extension; P, Phase; PY, patient‐years; ULN, upper limit of normal.
The average total daily dose (TDD) of tofacitinib was calculated: patients were assigned to the 5 mg BID group if the TDD was <15 mg/d and to the 10 mg BID group if it was ≥15 mg/d.
The P123LTE population (Asia‐Pacific) included patients from one Phase 1 study, four Phase 2 studies, six Phase 3 studies, and two LTE studies.
The global population (Asia‐Pacific and all other study locations) included patients from two Phase 1 studies, 10 Phase 2 studies, six Phase 3 studies, and two LTE studies.