Week 12 | Week 24 | |||||||
---|---|---|---|---|---|---|---|---|
Baricitinib | Baricitinib | |||||||
Placebo once daily (N=98) | 1 mg once daily (N=49) | 2 mg once daily (N=52) | 4 mg once daily (N=52) | 8 mg once daily (N=50) | 2 mg once daily (N=52) | 4 mg once daily (N=52) | 8 mg once daily (N=50) | |
Neutrophil count, 103 cells/mm3 | −0.02±1.51 | −0.43±1.42 | −0.59±1.66* | −0.30±1.79 | −0.68±2.06* | −0.25±2.18 | −0.21±2.02 | −1.37±2.33 |
Lymphocyte count, 103 cells/mm3 | −0.18±0.60 | −0.01±0.65 | −0.05±0.48 | 0.06±0.62* | −0.16±0.74 | −0.01±0.50 | −0.03±0.66 | 0.10±0.61 |
Platelet count, 103 cells/mm3 | 9.6±43.3 | −4.1±45.0 | 13.7±37.0 | 31.1±59.8* | 50.2±64.5*** | 18.9±36.8 | 33.5±66.1 | 48.5±59.9 |
Haemoglobin, g/dL | −0.14±0.62 | 0.12±0.75* | −0.09±0.67 | −0.15±0.80 | −0.54±0.92** | −0.28±1.10 | −0.24±0.91 | −0.44±1.04 |
ALT, IU/L | 3.5±20.7 | 0.2±15.3 | 3.6±14.6 | 7.5±33.8 | 2.8±15.4 | 2.2±14.6 | 2.5±12.7 | 2.8±23.0 |
HDL, mg/dL | 0.7±8.5 | 3.3±9.1 | 3.0±12.2 | 7.3±12.9*** | 8.1±13.9*** | 3.5±10.0 | 5.7±12.6 | 10.0±11.5 |
LDL, mg/dL | −4.7±25.1 | 3.4±24.2 | 8.0±24.1** | 9.5±30.3** | 11.8±23.5*** | 11.5±22.8 | 8.8±32.6 | 14.0±30.9 |
Creatinine, mg/dL | 0.01±0.08 | 0.02±0.10 | 0.04±0.10* | 0.11±0.36* | 0.08±0.27* | 0.04±0.10 | 0.05±0.08 | 0.07±0.13 |
Creatine phosphokinase, U/L | 17±307 | 15±38 | 21±59 | 49±96 | 70±133 | 25±66 | 41±81 | 70±89 |
Data represented as mean change from baseline±SD.
*p<0.05, **p<0.01 and ***p<0.001 versus placebo; p values derived using two-sided t test comparing the baricitinib dose versus placebo.
ALT, alanine aminotransferase; HDL, high-density lipoprotein; LDL, low-density lipoprotein.