Table 2.
Percentage change from baseline to week 12 in lipid parameters and lipid particles* (observed cases), ITT population
| Placebo+MTX (n=63) |
TCZ 8 mg/kg+MTX (n=69) |
Estimate* (95% CI) p for difference at week 12 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actual values | Change from baseline (%) | Actual values | Change from baseline (%) | ||||||||||
| n | Median | IQR | n† | Median | IQR | n | Median | IQR | n† | Median | IQR | ||
| Total cholesterol (mmol/L) | |||||||||||||
| Baseline | 58 | 4.8 | 4.3–5.5 | 55 | – | – | 64 | 4.7 | 4.2–5.3 | 56 | – | – | |
| Week 12 | 60 | 4.8 | 4.4–5.8 | 55 | 1.7 | –9.0–11.6 | 60 | 5.3 | 4.6–6.1 | 56 | 12.6 | –0.5–23.9 | 10.4 (4.8 to 16.9) p=0.0004 |
| LDL-C (mmol/L) | |||||||||||||
| Baseline | 55 | 3.1 | 2.5–3.5 | 50 | – | – | 56 | 2.8 | 2.4–3.4 | 48 | – | – | |
| Week 12 | 56 | 3.1 | 2.5–3.8 | 50 | –1.9 | –8.7–12.7 | 57 | 3.1 | 2.5–3.8 | 48 | 10.6 | 1.0–28.9 | 11.0(3.8 to 18.6) p=0.0076 |
| HDL-C (mmol/L) | |||||||||||||
| Baseline | 58 | 1.3 | 1.1–1.6 | 54 | – | – | 62 | 1.3 | 1.1–1.6 | 53 | – | – | |
| Week 12 | 60 | 1.4 | 1.1–1.6 | 54 | 2.4 | –10.2–9.3 | 60 | 1.5 | 1.2–1.6 | 53 | 3.1 | –6.6–12.7 | 3.0 (–2.4 to 8.6) p=0.2753 |
| Triglycerides (mmol/L) | |||||||||||||
| Baseline | 58 | 1.3 | 1.1–1.9 | 55 | – | – | 64 | 1.2 | 1.0–1.8 | 56 | – | – | |
| Week 12 | 60 | 1.2 | 1.1–1.7 | 55 | 2.2 | –18.7–18.7 | 60 | 1.5 | 1.1–2.3 | 56 | 28.1 | –1.7–63.5 | 25.4 (10.1 to 40.8) p=0.0011 |
| Total cholesterol/HDL (ratio) | |||||||||||||
| Baseline | 58 | 3.8 | 3.2–4.4 | 55 | – | – | 62 | 3.6 | 2.8–4.5 | 54 | – | – | |
| Week 12 | 60 | 3.9 | 3.2–4.8 | 55 | 0.9 | –7.5–7.9 | 60 | 3.9 | 3.1–4.4 | 54 | 11.3 | 2.0–19.4 | 9.7 (4.3 to 14.5) p=0.0008 |
| ApoB/ApoA1 (ratio) | |||||||||||||
| Baseline | 58 | 0.67 | 0.57–0.77 | 55 | – | – | 64 | 0.68 | 0.49–0.80 | 56 | – | – | |
| Week 12 | 60 | 0.70 | 0.56–0.79 | 55 | 2.5 | –7.8–11.0 | 60 | 0.67 | 0.52–0.75 | 56 | 4.7 | –4.2–15.8 | 2.1(–4.1 to 7.9) p=0.5108 |
| Large VLDL/chylomicrons (nmol/L) | |||||||||||||
| Baseline | 59 | 1.1 | 0.5–2.8 | 53 | – | – | 63 | 1.3 | 0.20–4.30 | 51 | – | – | |
| Week 12 | 60 | 1.2 | 0.3–4.1 | 53 | 0.0 | –50.0–67.5 | 59 | 3.7 | 1.30–7.40 | 51 | 205.6 | 0.0–700.0 | 167.5 (68.5 to 280.6) p<0.0001 |
| Medium VLDL/chylomicrons (nmol/L) | |||||||||||||
| Baseline | 59 | 22.1 | 12.0–38.3 | 56 | – | – | 63 | 22.0 | 11.0–32.7 | 55 | – | – | |
| Week 12 | 60 | 21.9 | 12.1–30.5 | 56 | –2.1 | –31.8–56.0 | 59 | 28.2 | 17.2–47.4 | 55 | 57.7 | –19.1–123.6 | 41.3(9.2 to 77.5) p=0.0088 |
| Small VLDL/chylomicrons (nmol/L) | |||||||||||||
| Baseline | 59 | 35.6 | 29.1–48.1 | 56 | – | – | 63 | 30.4 | 18.7–40.0 | 55 | – | – | |
| Week 12 | 60 | 36.2 | 26.2–46.2 | 56 | –6.1 | –25.1–17.9 | 59 | 40.1 | 26.5–57.2 | 55 | 31.4 | 10.2–91.5 | 42.3 (24.1 to 60.5) p<0.0001 |
| IDL particles (nmol/L) | |||||||||||||
| Baseline | 59 | 33.0 | 9.0–57.0 | 51 | – | – | 63 | 31.0 | 7.0–71.0 | 46 | – | – | |
| Week 12 | 60 | 36.0 | 9.0–59.5 | 51 | –9.4 | –49.6–133.3 | 59 | 39.0 | 11.0–92.0 | 46 | 33.5 | –60.9–222.6 | 14.3 (–37.3 to 70.0) p=0.5853 |
| Large LDL particles (nmol/L) | |||||||||||||
| Baseline | 59 | 396.0 | 261.0–508.0 | 56 | – | – | 63 | 405.0 | 253.0–535.0 | 55 | – | – | |
| Week 12 | 60 | 479.5 | 331.5–544.5 | 56 | 13.2 | –9.4–35.3 | 59 | 495.0 | 306.0–605.0 | 55 | 18.6 | –18.6–46.9 | –0.16 (–17.9 to 17.2) p=0.9718 |
| Large HDL particles (µmol/L) | |||||||||||||
| Baseline | 59 | 6.9 | 4.7–9.9 | 56 | – | – | 63 | 7.0 | 4.6–10.6 | 55 | – | – | |
| Week 12 | 60 | 7.8 | 5.5–11.0 | 56 | 1.8 | –15.5–13.4 | 59 | 8.4 | 5.3–11.6 | 55 | 5.6 | –8.6–23.7 | 4.8 (–5.9 to 15.1) p=0.4140 |
| Medium HDL particles (µmol/L) | |||||||||||||
| Baseline | 59 | 3.0 | 0.5–6.4 | 46 | – | – | 63 | 4.8 | 1.9–7.6 | 52 | – | – | |
| Week 12 | 60 | 3.2 | 1.5–7.4 | 46 | 2.0 | –30.4–56.5 | 59 | 4.2 | 1.2–7.5 | 52 | –25.0 | –71.5–25.8 | –30.7 (–61.3 to –0.23) p=0.0454 |
| Small HDL particles (µmol/L) | |||||||||||||
| Baseline | 59 | 19.9 | 14.9–24.0 | 56 | – | – | 63 | 17.4 | 13.0–21.1 | 55 | – | – | |
| Week 12 | 60 | 20.7 | 13.1–23.1 | 56 | 2.8 | –10.8–21.9 | 59 | 20.9 | 18.2–25.7 | 55 | 23.0 | 0.0–55.4 | 20.3 (7.9 to 34.0) p=0.0012 |
Data were missing at time points (including baseline) for some parameters. All values have been converted to SI units. No imputation was used for missing values. Only the latest fasted values within the time window are included.
*Hodges–Lehmann estimate of location shift (pseudo-median). p was calculated from Kruskal–Wallis test.
†Percentage change from baseline values includes only patients with both baseline and 12-week values.
Apo, apolipoprotein; C, cholesterol; HDL, high-density lipoprotein; IDL, intermediate-density lipoprotein; ITT, intent-to-treat; LDL, low-density lipoprotein; MTX, methotrexate; TCZ, tocilizumab; VLDL, very low-density lipoprotein.