Changes in laboratory results (patients who worsened to that grade from baseline). Data are n (%) and indicate no. patients treated with stated dose regimen in the study period.
| Blinded Period, Weeks 0–24 Randomized Dose | First OLE, Weeks 24–76 | Second OLE, Weeks 76–128 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 4:8 mg | ||||||||||
| 2 mg, n = 52 | 4 mg, n = 52 | 8 mg, n = 50 | 4 mg, n = 108 | Pre-rescue, n = 61 | Post-rescue, n = 61 | 8 mg, n = 32 | 4/4 mg, n = 79 | 4:8/4 mg, n = 47 | 8/4 mg, n = 18 | |
| Decreased neutrophils | ||||||||||
| Grade 1: ≥ 1500 cells/mm3 to < LLN | 4 (8) | 1 (2) | 5 (10) | 17 (16) | 2 (3) | 5 (8) | 3 (9) | 5 (6) | 6 (13) | 0 |
| Grade 2: ≥ 1000 to < 1500 cells/mm3 | 3 (6) | 5 (10) | 9 (18) | 1 (1) | 1 (2) | 3 (5) | 3 (9) | 2 (3) | 1 (2) | 1 (6) |
| Grade 3: ≥ 500 to < 1000 cells/mm3 | 1 (2) | 0 | 1 (2) | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 |
| Decreased lymphocytes | ||||||||||
| Grade 1: ≥ 800 cells/mm3 to < LLN | 6 (12) | 8 (15) | 10 (20) | 15 (14) | 4 (7) | 5 (8) | 4 (13) | 7 (9) | 5 (11) | 3 (17) |
| Grade 2: ≥ 500 to < 800 cells/mm3 | 2 (4) | 6 (12) | 10 (20) | 5 (5) | 0 | 5 (8) | 4 (13) | 9 (11) | 4 (9) | 3 (17) |
| Grade 3: ≥ 200 to < 500 cells/mm3 | 0 | 0 | 0 | 0 | 0 | 1 (2) | 1 (3) | 0 | 0 | 0 |
| Elevated platelets | ||||||||||
| Platelet count > 600,000 cells/µla | 0 | 2 (4) | 0 | 2 (2) | 0 | 1 (2) | 1 (3) | 1 (1) | 0 | 0 |
| Decreased hemoglobin | ||||||||||
| Grade 1: ≥ 10.0 g/dl to < LLN | 10 (19) | 11 (21) | 18 (36) | 22 (20) | 5 (8) | 12 (20) | 5 (16) | 14 (18) | 4 (9) | 1 (6) |
| Grade 2: ≥ 8.0 to < 10.0 g/dl | 4 (8) | 4 (8) | 6 (12) | 1 (1) | 0 | 3 (5) | 2 (6) | 1 (1) | 2 (4) | 2 (11) |
| Grade 3: < 8.0 to ≥ 6.5 g/dl | 0 | 0 | 0 | 2 (2) | 0 | 1 (2) | 1 (3) | 0 | 0 | 0 |
| Grade 4: < 6.5 g/dl | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 |
| Elevated ALT | ||||||||||
| Grade 1: > ULN and ≤ 2.5 × ULN | 8 (15) | 12 (23) | 12 (24) | 18 (17) | 2 (3) | 14 (23) | 5 (16) | 16 (20) | 9 (19) | 1 (6) |
| Grade 2: > 2.5 × ULN and ≤ 5 × ULN | 1 (2) | 3 (6) | 1 (2) | 7 (6) | 0 | 0 | 1 (3) | 2 (3) | 4 (9) | 0 |
| Grade 3: > 5 × ULN and ≤ 20 × ULN | 0 | 1 (2) | 1 (2) | 2 (2) | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 4: > 20 × ULN | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3) | 0 | 0 | 0 |
| Elevated creatinine | ||||||||||
| Grade 1: > ULN and ≤ 1.5 × ULN | 3 (6) | 6 (12) | 2 (4) | 8 (7) | 1 (2) | 3 (5) | 1 (3) | 4 (5) | 0 | 0 |
| Grade 2: > 1.5 × ULN and ≤ 3 × ULN | 0 | 1 (2) | 1 (2) | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 |
Baseline in the blinded period is Week 0, baseline in the first OLE is Week 24, and baseline in the second OLE is Week 76. Laboratory grades defined using Common Terminology Criteria for Adverse Events, version 4.0. 4/4 mg = 4 mg baricitinib through Week 128. 4:8/4 = 4 mg baricitinib through Week 28 or 32, then 8 mg through Week 76 and 4 mg for weeks 76–128. 8/4 mg = 8 mg baricitinib through Week 76 and 4 mg for weeks 76–128. Pre-rescue includes all abnormalities that occurred on or before the date of dose escalation. Post-rescue includes all abnormalities that occurred after the date of dose escalation.
↵a Incidence of protocol-defined thrombocytosis in patients with platelet counts > 600,000 cells/µl. ALT: alanine aminotransferase; LLN: lower limit of normal; OLE: open-label extension; ULN: upper limit of normal.