Table 2:
Demographic comparison between the high CIMT progression group and low CIMT progression group in the APPLE study placebo-treated participants (N=60).
| Total Placebo | High CIMT progression group | Low CIMT progression group | P * | |
|---|---|---|---|---|
|
| ||||
| Number | 60 | 35 | 25 | - |
| Sex, no. (%) female | 51 (85.0) | 29 (82.9) | 22 (88.0) | 0.855 |
| Puberty at baseline, no. (%) post puberty | 38 (63.3) | 21 (60.0) | 17 (68.0) | 0.564 |
| Age, mean ± SD years | 15.50 ± 2.48 | 15.46 ± 2.49 | 15.56 ± 2.52 | 0.876 |
|
| ||||
| Race, no. (%) | 0.848 | |||
|
| ||||
| White | 35 (58.33) | 19 (54.29) | 16 (64.0) | |
| Black | 13 (21.67) | 8 (22.86) | 5 (20) | |
| Asian | 4 (6.67) | 3 (8.57) | 1 (4.0) | |
| Other | 8 (13.33) | 5 (14.29) | 3 (12) | |
|
| ||||
| Annual household income, no. (%) | 0.763 | |||
|
| ||||
| <$25,000 | 16 (26.67) | 9 (25.71) | 7 (28) | |
| $25,000–49,999 | 17 (28.33) | 9 (25.71) | 8 (32) | |
| $50,000–74,999 | 7 (11.67) | 5 (14.29) | 2 (8) | |
| $75,000–99,999 | 8 (13.33) | 6 (17.14) | 2 (8) | |
| $100,000–150,000 | 6 (10) | 2 (5.71) | 4 (16) | |
| >$150,000 | 3 (5) | 2 (5.71) | 1 (4) | |
|
| ||||
| Patient and disease characteristics at baseline | ||||
|
| ||||
| BMI, mean ± SD kg/m2 | 24.51 ± 6.19 | 24.91 ± 6.60 | 23.94 ± 5.66 | 0.555 |
| Duration of lupus, mean ± SD months | 28.05 ± 30.11 | 27.89 ± 34.68 | 28.28 ± 22.88 | 0.961 |
| SLEDAI, mean ± SD | 4.02 ± 3.96 | 4.51 ± 3.98 | 3.32 ± 3.90 | 0.253 |
| SLICC DI, mean ± SD | 0.333 ± 0.774 | 0.457 ± 0.886 | 0.160 ± 0.554 | 0.144 |
| Hypertension, no. (%) | 23 (38.3) | 16 (45.7) | 7 (28.0) | 0.262 |
| History of smoking, no. (%) | 0 (0) | 0 (0) | 0 (0) | - |
| dsDNA antibody positive, no. (%) | 45 (75.0) | 24 (68.6) | 21 (84.0) | 0.290 |
| Creatinine clearance, mean ± SD ml/minute/m2 | 133.18 ± 28.66 | 134.59 ± 28.24 | 131.21 ± 29.7 | 0.891 |
| C3, mean ± SD mg/dl | 106.2 ± 25.24 | 110.50 ± 24.53 | 100.05 ± 25.50 | 0.121 |
| C4, mean ± SD mg/dl | 16.95 ± 7.72 | 17.85 ± 8.18 | 15.63 ± 6.96 | 0.282 |
|
| ||||
| Medications at baseline (past 30 days) | ||||
|
| ||||
| Aspirin, no. (%) | 43 (71.67) | 24 (68.57) | 19 (76) | 0.735 |
| Hydroxychloroquine, no. (%) | 59 (98.33) | 34 (97.14) | 25 (100) | 1 |
| Multivitamin, no. (%) | 42 (70) | 23 (65.71) | 19 (76) | 0.568 |
| Corticosteroids, no. (%) | 48 (80) | 29 (82.86) | 19 (76) | 0.743 |
| Cyclophosphamide, no. (%) | 10 (16.67) | 6 (17.14) | 4 (16) | 1 |
| Mycophenolate mofetil, no. (%) | 11 (18.33) | 8 (22.86) | 3 (13.04) | 0.463 |
| Azathioprine, no. (%) | 11 (18.33) | 7 (20) | 4 (16) | 0.955 |
| Methotrexate, no. (%) | 8 (13.33) | 5 (14.29) | 3 (12) | 1 |
| Rituximab, no. (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | - |
| NSAIDs, no. (%) | 19 (31.67) | 9 (25.71) | 10 (40) | 0.373 |
| ACE inhibitor, no. (%) | 17 (28.33) | 11 (31.43) | 6 (24) | 0.735 |
|
| ||||
| Serum biomarkers at baseline | ||||
|
| ||||
| hsCRP, mean ± SD mg/liter | 2.88 ± 6.50 | 2.93 ± 6.13 | 2.82 ± 7.11 | 0.953 |
| Homocysteine, mean ± SD μmoles/liter | 7.52 ± 4.24 | 8.08 ± 4.97 | 6.76 ± 2.91 | 0.24 |
|
| ||||
| Lipid levels at baseline, mean ± SD mg/dl | ||||
|
| ||||
| Total cholesterol**** | 144.59 ± 31.3 | 156.97 ± 32.91 | 127.76 ± 19.12 | <0.001 |
| HDL cholesterol**** | 45.92 ± 12.71 | 48.38 ± 13.53 | 42.56 ± 10.88 | 0.082 |
| LDL cholesterol** ** | 74.09 ± 26.75 | 83.24 ± 27.98 | 62.00 ± 19.71 | 0.002 |
| Triglycerides | 128.12 ± 94.52 | 136.62 ± 115.75 | 116.56 ± 54.09 | 0.425 |
| Lipoprotein A | 12.25 ± 16.04 | 14.82 ± 17.61 | 8.76 ± 13.17 | 0.153 |
Chi-squared test or Wilcoxon signed-rank test. Tanner Stage 4–5 are classified as post-puberty.
The recommended lipid levels in people younger than 18 years of age (as per APPLE trial inclusion criteria) are: total cholesterol <170 mg/dl, HDL-cholesterol>45 mg/dl and LDL-cholesterol <110 mg/dl. Lipid levels fluctuate and they are not usually monitored during puberty.
ACE – angiotensin-converting enzyme inhibitors; BMI – Body mass index; C3, C4 – complement fractions C3,C4; HDL – high-density lipoprotein; hsCRP – high sensitivity C-Reactive Protein; LDL – low-density lipoprotein; NSAIDs – non-steroidal anti-inflammatory drugs; SLEDAI – Systemic Lupus Erythematosus Disease Activity Index; SLICC DI – Systemic Lupus International Collaborating Clinics Damage Index.