Change from each OLE baseline for selected laboratory analytes. Data represented as mean change from baseline ± SD. 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.
| 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 | |
| Neutrophil count, 103 cells/mm3 | −0.25 ± 2.18 | −0.21 ± 2.02 | −1.37 ± 2.33 | 0.32 ± 2.09 | 0.11 ± 1.70 | 0.29 ± 2.08 | 0.83 ± 2.06 | −0.03 ± 1.59 | −0.42 ± 1.94 | −0.34 ± 1.68 |
| Lymphocyte count, 103 cells/mm3 | −0.01 ± 0.50 | −0.03 ± 0.66 | 0.10 ± 0.61 | −0.17 ± 0.54 | 0.10 ± 0.69 | −0.23 ± 0.72 | −0.43 ± 0.58 | −0.06 ± 0.61 | 0.03 ± 0.50 | −0.02 ± 0.59 |
| Platelet count, 103 cells/mm3 | 19 ± 37 | 34 ± 66 | 49 ± 60 | −1 ± 66 | 4 ± 66 | 8 ± 60 | 11 ± 74 | 8 ± 47 | −12 ± 62 | −33 ± 45 |
| Hemoglobin, g/dl | −0.28 ± 1.10 | −0.24 ± 0.91 | −0.44 ± 1.04 | 0.04 ± 0.73 | −0.02 ± 1.07 | 0.12 ± 0.92 | 0.06 ± 0.99 | 0.08 ± 0.62 | 0.24 ± 0.69 | 0.23 ± 1.23 |
| ALT, IU/l | 2.2 ± 14.6 | 2.5 ± 12.7 | 2.8 ± 23.0 | 4.8 ± 36.4 | −1.3 ± 8.4 | 5.1 ± 15.7 | 83.4 ± 466.7 | −0.7 ± 19.0 | 3.0 ± 19.8 | −7.7 ± 16.5 |
| HDL-C, mg/dl | 3.5 ± 10.0 | 5.7 ± 12.6 | 10.0 ± 11.5 | −1.4 ± 10.4 | 0.4 ± 12.4 | −0.1 ± 15.1 | −3.7 ± 15.3 | 1.4 ± 9.4 | 1.0 ± 13.7 | 0.2 ± 11.7 |
| LDL-C, mg/dl | 11.5 ± 22.8 | 8.8 ± 32.6 | 14.0 ± 30.9 | 5 ± 27 | −2 ± 19 | 7 ± 29 | 4 ± 35 | −4 ± 34 | 5 ± 36 | −1 ± 26 |
| Creatinine, mg/dl | 0.04 ± 0.10 | 0.05 ± 0.08 | 0.07 ± 0.13 | 0.001 ± 0.115 | −0.006 ± 0.093 | −0.010 ± 0.119 | −0.008 ± 0.120 | 0.000 ± 0.081 | 0.000 ± 0.104 | −0.016 ± 0.078 |
| Creatine phosphokinase, U/l | 25 ± 66 | 41 ± 81 | 70 ± 89 | 39 ± 171 | 24 ± 93 | −6 ± 139 | 18 ± 108 | −33 ± 204 | −26 ± 97 | 24 ± 99 |
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. “n” mean no. patients treated with stated dose regimen in the study period. Pre-rescue includes all laboratory results obtained prior to dose escalation. Post-rescue includes all laboratory results obtained after dose escalation.
↵* For patients with dose escalation, the value obtained at the dose escalation visit is used instead of baseline at Week 24 for the post-rescue time period. ALT: alanine aminotransferase; HDL-C: high-density lipoprotein cholesterol; LDL-C: low-density lipoprotein cholesterol; OLE: open-label extension.