Table 5.
Change in Advanced Lipoprotein Characterization, Glucose Metabolism, and Inflammation
| Change a Ustekinumab vs. Placebo (Week 12) (n=40) |
Change b End of study compared to Baseline (n=38) |
Change b End of study compared to Start of Ustekinumab (n=38) |
|
|---|---|---|---|
| Inflammatory | |||
| ICAM-1 | −64.97 (−155.83, 25.89) | 6.65 (−38.41, 51.72) | −27.68 (−81.21, 25.85) |
| VCAM-1 | −80.89 (−142.55, −19.23) * | −1.99 (−30.58, 26.59) | −28.98 (−58.63, 0.67) |
| SAA | −7884.29 (−23634.67, 7866.10) | −3782.54 (−12035.72, 4470.64) | −3931.92 (−12167.24, 4303.41) |
| CRP | −3027.21 (−9465.95, 3411.53) | −1974.63 (−5336.30, 1387.04) | −2264.77 (−5579.82, 1050.28) |
| Ferritin | 20.66 (−78.03, 119.34) | 47.00 (−25.63, 119.63) | 62.45 (−17.47, 142.37) |
| IFN-g | −0.07 (−5.22, 5.07) | −1.09 (−3.29, 1.11) | −1.13 (−3.26, 1.01) |
| MCP-1 | −14.79 (−55.19, 25.61) | −7.24 (−30.47, 15.99) | −7.83 (−28.97, 13.32) |
| TNF-a | −0.90 (−2.27, 0.47) | −0.67 (−1.36, 0.02) | −1.02 (−1.89, −0.14) * |
| GlycA | −4.14 (−27.24, 18.96) | −8.35 (−25.40, 8.69) | −11.19 (−28.85, 6.46) |
| IL-1b | −0.52 (−1.56, 0.51) | −0.31 (−0.54, −0.08) * | −0.61 (−1.01, −0.21) ** |
| IL-2ra | −70.76 (−138.42, −3.11) * | 71.72 (−197.50, 340.93) | 71.27 (−198.21, 340.76) |
| IL-12/23 | 191.49 (98.18, 284.81) *** | 171.21 (130.08, 212.34) *** | 168.40 (127.79, 209.01) *** |
| IL-17a | −2.63 (−4.62, −0.64) | −1.15 (−1.79, −0.51) *** | −1.13 (−1.72, −0.55) *** |
| IL-18 | −155.31 (−1548.66, 1238.04) | −407.43 (−773.57, −41.29) * | −644.75 (−1170.13, −119.37) * |
| IL-6 | −0.47 (−1.25, 0.32) | −0.38 (−0.80, 0.03) | −0.39 (−0.79, −0.00) * |
| IL-8 | −16.87 (−48.48, 14.75) | −2.23 (−5.69, 1.22) | −11.95 (−28.91, 5.02) |
| Lipid | |||
| Triglyceride | 2.06 (−24.09, 28.20) | 10.55 (−6.18, 27.29) | 12.21 (−3.43, 27.85) |
| Total cholesterol | 19.20 (4.21, 34.20) | −0.79 (−9.19, 7.61) | 2.13 (−5.52, 9.78) |
| Hdl-cholesterol | 3.66 (−0.30, 7.62) | 1.92 (−0.95, 4.80) | 2.39 (−0.42, 5.21) |
| Hdl-particle number | 1.25 (−0.83, 3.34) | 0.91 (−0.56, 2.37) | 1.38 (0.00, 2.76) * |
| Hdl-particle size | −0.11 (−0.34, 0.11) | 0.17 (0.04, 0.31) * | 0.09 (−0.06, 0.24) |
| Large-hdl-particle number | 0.12 (−1.09, 1.33) | 0.51 (−0.22, 1.24) | 0.33 (−0.41, 1.06) |
| Small-hdl-particle number | 2.49 (−0.94, 5.93) | 0.21 (−1.49, 1.91) | 1.53 (−0.15, 3.21) |
| Medium-hdl-particle number | −1.37 (−4.79, 2.05) | 0.17 (−1.80, 2.13) | −0.47 (−2.11, 1.17) |
| Large medium-hdl-particle number | −1.12 (−4.95, 2.71) | 0.77 (−1.25, 2.80) | −0.03 (−1.71, 1.64) |
| Ldl-cholesterol | 21.37 (7.86, 34.87)** | −2.92 (−11.17, 5.33) | 0.97 (−6.40, 8.34) |
| Ldl-particle number | 230.77 (89.47, 372.08) ** | −31.89 (−116.40, 52.61) | 15.24 (−60.81, 91.28) |
| Ldl-particle size | 0.04 (−0.30, 0.38) | 0.03 (−0.19, 0.24) | −0.03 (−0.22, 0.17) |
| Small-ldl-particle number | 46.96 (−66.65, 160.57) | 4.68 (−63.91, 73.28) | 6.14 (−60.97, 73.26) |
| Large-ldl-particle number | 7.01 (−91.80, 105.81) | −24.74 (−90.78, 41.30) | −30.37 (−95.86, 35.12) |
| Very large-ldl-particle number | 194.69 (60.61, 328.77) ** | −29.16 (−106.17, 47.85) | 11.63 (−58.44, 81.70) |
| Vldl-particle size | 3.14 (−2.55, 8.83) | 1.50 (−1.36, 4.36) | 1.23 (−1.58, 4.05) |
| Vldl-particle number | −16.74 (−30.03, −3.45) * | −0.11 (−6.93, 6.71) | −2.44 (−9.22, 4.33) |
| Vldl-triglycerides | −9.21 (−33.03, 14.60) | 11.14 (−3.72, 25.99) | 10.10 (−3.31, 23.52) |
| Small-vldl-particle number | −15.71 (−27.39, −4.03) ** | −0.50 (−4.69, 3.70) | −4.53 (−10.50, 1.43) |
| Medium-vldl-particle number | 0.34 (−8.91, 9.59) | −1.86 (−6.77, 3.06) | 0.43 (−4.96, 5.81) |
| Large medium-vldl-particle number | 0.08 (−10.37, 10.53) | 0.38 (−4.86, 5.63) | 2.25 (−3.29, 7.78) |
| Large-vldl-particle number | −0.28 (−2.91, 2.36) | 2.30 (0.12, 4.48) * | 2.06 (0.10, 4.03) * |
| Idl-particle number | 152.65 (64.07, 241.23) ** | −2.97 (−55.04, 49.09) | 41.66 (−5.12, 88.44) |
| Cholesterol Efflux Capacity | 0.06 (−0.03, 0.14) | 0.04 (−0.03, 0.10) | 0.02 (−0.05, 0.08) |
| Apolipoprotein-B | 0.15 (−0.11, 0.41) | 0.10 (−0.02, 0.23) | 0.13 (−0.01, 0.28) |
| Fetuin-A | 48.43 (−76.31, 173.16) | −49.56 (−105.97, 6.85) | −17.19 (−67.52, 33.15) |
| Metabolic | |||
| Adiponectin | −0.28 (−2.52, 1.97) | 0.38 (−0.65, 1.40) | 0.16 (−0.78, 1.10) |
| Leptin | 3320.58 (−3592.51, 10233.67) | 6926.25 (2351.43, 11501.07) ** | 4524.61 (469.82, 8579.41) * |
| Insulin | −68.95 (−335.97, 198.08) | −7.96 (−182.18, 166.26) | −53.02 (−224.40, 118.37) |
| Glucose c | 4.20 (−6.28, 14.68) | 3.41 (−3.54, 10.36) | 4.08 (−2.37, 10.53) |
| HOMA-IR | −0.49 (−3.56, 2.59) | −0.07 (−1.88, 1.73) | −0.31 (−2.10, 1.48) |
a
Difference of difference (95% CI)
b
Difference (95% CI)
c
For glucose, n of 41, 39, and 39 for Week 12, Baseline to End of Study, and Start of Ustekinumab to End of Study analyses, respectively
*
p<0.05
**
p<0.01
***
p<0.001
ICAM-1: intercellular adhesion molecule-1, VCAM-1: vascular cell adhesion molecule-1, SAA: serum amyloid A, CRP: C-reactive protein, IFN-g: interferon-gamma, MCP-1: monocyte chemoattractant protein-1, TNF-a, tumor necrosis factor-alpha, IL-interleukin, HDL: high-density lipoprotein, LDL: low-density lipoprotein, VLDL: very low-density lipoprotein, IDL: intermediate-density lipoprotein, HOMA-IR: homeostasis model assessment of insulin resistance.