Table 1:
Baseline characteristics at screening by race and ethnicity groups (n=4,873). (*NHWs: Non-Hispanic Whites, NHBs: Non-Hispanic Blacks)
| Hispanics (n=537) |
NHWs (n=3940) |
NHBs (n=143) |
Non-Hispanic Other Races (n=253) |
p-value (Overall) |
p-value (Hispanic vs NHWs) |
|
|---|---|---|---|---|---|---|
| Age (years) | ||||||
| median | 12.4 | 12.0 | 11.2 | 11.7 | 0.51 | 0.19 |
| range | 1.3 to 48.7 | 1.06 to 51.8 | 2.6 to 45.7 | 1.7 to 46 | ||
| missing | 0 | 0 | 1 | 0 | ||
| Sex, n (%) | ||||||
| female | 303 (57%) | 2001 (51%) | 84 (59%) | 144 (57%) | 0.006 | 0.02 |
| male | 230 (43%) | 1934 (49%) | 59 (41%) | 107 (43%) | ||
| missing | 4 | 5 | 0 | 2 | ||
| Autoantibody status at screening, n (%) | ||||||
| Single confirmed (+) | 280 (52%) | 1585 (40%) | 48 (34%) | 126 (50%) | <0.00001 | <0.00001 |
| Multiple (+) | 257 (48%) | 2355 (60%) | 95 (66%) | 127 (50%) | ||
| 1 | 280 (52%) | 1585 (40%) | 48 (34%) | 126 (50%) | <0.00001 | <0.00001 |
| 2 | 113 (21%) | 1003 (26%) | 46 (36%) | 68 (27%) | ||
| 3 | 63 (12%) | 606 (15%) | 23 (12%) | 25 (10%) | ||
| 4 | 45 (8%) | 462 (12%) | 13 (10%) | 21 (8%) | ||
| 5 | 32 (6%) | 236 (6%) | 11 (7%) | 9 (4%) | ||
| Missing at least one autoantibody titre | 4 | 48 | 2 | 4 | ||
| DPTRS | ||||||
| median | 5.85 | 6.18 | 6.13 | 6.04 | <0.0001 | <0.00001 |
| range | 0.78 to 10.1 | 0.49 to 10.1 | 3.5 to 9.1 | 1.3 to 9.76 | ||
| <6.5, n (%) | 383 (75%) | 2289 (61%) | 89 (67%) | 155 (67%) | <0.0001 | <0.00001 |
| >= 6.5, n (%) | 126 (25%) | 1460 (39%) | 43 (33%) | 77 (33%) | ||
| missing | 28 | 191 | 11 | 21 | ||
| BMI percentile | ||||||
| Median | 81.1 | 67.8 | 76.4 | 69.0 | <0.0001 | <0.0001 |
| Range | 0 to 99.8 | 0 to 100 | 2.0 to 99.6 | 0 to 99.2 | ||
| Normal/Lean | 286 (55%) | 2682 (70%) | 75 (56%) | 164 (67%) | <0.0001 | <0.0001 |
| Overweight | 98 (19%) | 612 (16%) | 24 (18%) | 49 (20%) | ||
| Obese | 139 (26%) | 534 (14%) | 36 (27%) | 32 (13%) | ||
| missing | 14 | 112 | 8 | 8 | ||
| Subgroup 1: Single confirmed autoantibody positives (n=2039) | ||||||
| n=280 | n=1585 | n=48 | n=126 | |||
| Antibody type, n (%) | ||||||
| GAD65 | 195 (69.5%) | 1118 (70.5%) | 38 (79%) | 89 (70.5%) | 0.12 | 0.21 |
| IA-2 | 7 (2.5%) | 76 (5%) | 1 (2%) | 1 (1%) | ||
| mIAA | 78 (28%) | 391 (24.5%) | 9 (19%) | 36 (28.5%) | ||
| HLA DR3-DQ2/DR4-DQ8, n (%) | ||||||
| Both DR3-DQ2 and DR4-DQ8 present | 19 (7%) | 202 (13%) | 0 | 11 (10%) | 0.001 | 0.009 |
| Not both DR3-DQ2 and DR4-DQ8 present | 252 (93%) | 1306 (87%) | 46 (100%) | 104 (90%) | ||
| DR3-DQ2 and/or DR4-DQ8 present | 152 (56%) | 1142 (76%) | 29 (63%) | 80 (70%) | <0.0001 | <0.0001 |
| Neither present | 119 (44%) | 366 (24%) | 17 (37%) | 35 (30%) | ||
| missing | 9 | 77 | 2 | 11 | ||
| Fasting C-peptide (nmol/L) | ||||||
| median | 0.59 | 0.53 | 0.62 | 0.52 | 0.015 | 0.0015 |
| range | 0.13 to 1.93 | 0.02 to 2.5 | 0.17 to 1.27 | 0.06 to 3.38 | ||
| missing | 0 | 3 | 0 | 0 | ||
| Mean C-peptide AUC (nmol/L) | ||||||
| median | 2.19 | 1.98 | 1.9 | 2.0 | 0.0007 | <0.0001 |
| range | 0.31 to 8.23 | 0.28 to 8.27 | 0.72 to 3.91 | 0.4 to 8.77 | ||
| missing | 8 | 42 | 2 | 9 | ||
| BMI percentile | ||||||
| Median | 82.9 | 71.0 | 89.1 | 66.5 | <0.0001 | <0.0001 |
| Range | 0.45 to 99.8 | 0 to 100 | 2.8 to 99.6 | 0 to 99.1 | ||
| Normal/Lean | 139 (51%) | 1036 (67%) | 20 (44.5%) | 85 (70%) | <0.0001 | <0.0001 |
| Overweight | 52 (19%) | 253 (16.5%) | 11(24.5%) | 23 (19%) | ||
| Obese | 81 (30%) | 254 (16.5%) | 14 (31%) | 14 (11%) | ||
| missing | 8 | 42 | 3 | 4 | ||
| Subgroup 2: Multiple autoantibody positives (n=2834) | ||||||
| n=257 | n=2355 | n=95 | n=127 | |||
| HLA DR3-DQ2/DR4-DQ8, n (%) | ||||||
| Both DR3-DQ2 and DR4-DQ8 present | 58 (23%) | 532 (24%) | 11 (12%) | 21 (18%) | 0.03 | 0.99 |
| Not both DR3-DQ2 and DR4-DQ8 present | 194 (77%) | 1688 (76%) | 80 (88%) | 97 (82%) | ||
| DR3-DQ2 and/or DR4-DQ8 present | 183 (73%) | 1867 (84%) | 67 (74%) | 93 (79%) | <0.0001 | <0.0001 |
| Neither present | 69 (27%) | 353 (16%) | 24 (26%) | 25 (21%) | ||
| Missing | 5 | 135 | 4 | 9 | ||
| Fasting C-peptide (nmol/L) | ||||||
| median | 0.49 | 0.45 | 0.41 | 0.44 | 0.046 | 0.01 |
| range | 0.11 to 1.71 | 0.05 to 2.48 | 0.08 to 1.24 | 0.10 to 1.61 | ||
| missing | 0 | 5 | 0 | 0 | ||
| Mean C-peptide AUC (nmol/L) | ||||||
| median | 1.75 | 1.621 | 1.72 | 1.63 | 0.012 | 0.003 |
| range | 0.36 to 7.49 | 0.16 to 7.89 | 0.48 to 3.53 | 0.68 to 4.71 | ||
| missing | 10 | 52 | 2 | 6 | ||
| BMI percentile | ||||||
| Median | 79.3 | 65.9 | 73.5 | 72.1 | 0.0001 | 0.0006 |
| Range | 0 to 99.7 | 0 to 100 | 1.98 to 99.6 | 0.6 to 99.2 | ||
| Normal/Lean | 147 (59%) | 1646 (72%) | 55 (61%) | 79 (64%) | <0.0001 | <0.0001 |
| Overweight | 36 (18%) | 359 (16%) | 13 (14%) | 26 (21%) | ||
| Obese | 58 (23%) | 280 (12%) | 22 (24%) | 18 (15%) | ||
| missing | 6 | 70 | 5 | 4 | ||