Mean change from baseline to week 8* in lipid parameters (safety population)
| Statistic | ADA 40 mg SC q2w, n=162 | TCZ 8 mg/kg IV q4w, n=162 |
|---|---|---|
| Total cholesterol, mmol/L | ||
| Baseline | ||
| n | 145 | 150 |
| Mean (SD) | 4.94 (1.06) | 5.13 (1.11) |
| Change from baseline to week 8 | ||
| n | 129 | 138 |
| Mean (SD) | 0.17 (0.65) | 0.79 (0.97) |
| Difference in adjusted means (95% CI)† | 0.67 (0.47 to 0.86) | |
| p Value‡ | <0.0001 | |
| Triglycerides, mmol/L | ||
| Baseline | ||
| n | 145 | 150 |
| Mean (SD) | 1.39 (0.69) | 1.48 (0.97) |
| Change from baseline to week 8 | ||
| n | 129 | 138 |
| Mean (SD) | 0.07 (0.47) | 0.29 (0.68) |
| Difference in adjusted means (95% CI)† | 0.24 (0.10–0.38) | |
| p Value‡ | 0.0008 | |
| HDL-C, mmol/L | ||
| Baseline | ||
| n | 145 | 149 |
| Mean (SD) | 1.52 (0.38) | 1.56 (0.48) |
| Change from baseline to week 8 | ||
| n | 129 | 137 |
| Mean (SD) | 0.07 (0.25) | 0.14 (0.31) |
| Difference in adjusted means (95% CI)† | 0.07 (0.001 to 0.14) | |
| p Value‡ | 0.0453 | |
| LDL-C, mmol/L | ||
| Baseline | ||
| n | 144 | 146 |
| Mean (SD) | 2.78 (0.89) | 2.88 (0.87) |
| Change from baseline to week 8 | ||
| n | 128 | 133 |
| Mean (SD) | 0.07 (0.53) | 0.52 (0.79) |
| Difference in adjusted means (95% CI)† | 0.46 (0.30 to 0.62) | |
| p Value‡ | <0.0001 | |
| Total cholesterol/HDL ratio | ||
| Baseline | ||
| n | 145 | 149 |
| Mean (SD) | 3.40 (0.97) | 3.51 (1.11) |
| Change from baseline to week 8 | ||
| n | 129 | 137 |
| Mean (SD) | –0.01(0.51) | 0.24 (0.71) |
| Difference in adjusted means (95% CI)† | 0.27 (0.12 to 0.42) | |
| p Value‡ | 0.0005 | |
*Includes only patients with both baseline and week 8 worst fasting values.
†Difference and 95% CI were based on adjusted least square means (TCZ-ADA).
‡ANCOVA model was adjusted for baseline laboratory parameter. p Values were unadjusted for multiple testing; therefore, no statistical significance can be claimed.
ADA, adalimumab; ANCOVA, analysis of covariance; HDL, high-density lipoprotein; HDL-C, high-density lipoprotein cholesterol; IV, intravenous; LDL, low-density lipoprotein; LDL-C, low-density lipoprotein cholesterol; q2w, every 2 weeks; q4w, every 4 weeks; SC, subcutaneous; TCZ, tocilizumab.