Table 1: Characteristics of Population in Each of the Trial Data.
Table reports N (% in parentheses) with median (25th and 75th percentile) and mean ± SD for age, BMI, nodules, abscesses, draining tunnel counts, and baseline IHS4. P values calculated using chi-squared or Fisher’s exact test for categorical variables, Mann-Whitney U test for non-normally distributed continuous data and Welch’s t-test for normally distributed continuous data.
| Characteristic | PIONEER 1 | PIONEER 2 | ||||
|---|---|---|---|---|---|---|
| Adalimumab | Placebo | P value | Adalimumab | Placebo | P value | |
| N= | 144 | 145 | 149 | 140 | ||
| Female | 85 (59.0%) | 100 (69.0%) | 0.10 | 97 (65.1%) | 98 (70.0%) | 0.45 |
| Male | 59 (41.0%) | 45 (31.0%) | 52 (34.9%) | 42 (30.0%) | ||
| White | 111 (77.1%) | 113 (77.9%) | 0.35 | 130 (87.2%) | 110 (78.6%) | 0.07 |
| Black | 30 (20.8%) | 25 (17.2%) | 8 (5.4%) | 18 (12.9%) | ||
| Other | 3 (2.1%) | 7 (4.8%) | 11 (7.4%) | 12 (8.6%) | ||
| Median Age | 35.0 (28.0, 45.0) | 37.0 (30.0, 47.0) | 0.14 | 35.0 (27.0, 42.0) | 35.0 (26.0, 43.3) | 0.49 |
| Mean Age | 36.5 ± 11.0 | 38.4 ± 11.4 | 34.8 ± 10.1 | 36.4 ± 12.2 | ||
| Median BMI | 32.1 (27.1, 38.0) | 33.9 (28.5, 39.4) | 0.07 | 30.3 (26.3, 36.0) | 31.3 (26.8, 36.0) | 0.22 |
| Mean BMI | 32.9 ± 7.7 | 34.6 ± 8.1 | 30.9 ± 6.4 | 31.8 ± 6.8 | ||
| Hurley 2 | 80 (55.6%) | 79 (54.5%) | 0.95 | 76 (51.0%) | 79 (56.4%) | 0.42 |
| Hurley 3 | 64 (44.4%) | 66 (45.5%) | 73 (49.0%) | 61 (43.6%) | ||
| Nicotine Use | 77 (53.5%) | 88 (60.7%) | 0.26 | 96 (64.4%) | 99 (70.7%) | 0.31 |
| Family History | 37 (25.7%) | 28 (19.3%) | 0.25 | 36 (24.2%) | 39 (27.9%) | 0.56 |
| Presence of Draining Tunnels | 108 (75.0%) | 108 (74.5%) | 1.0 | 99 (66.4%) | 87 (62.1%) | 0.52 |
| Antibiotics | - | - | 27 (18.1%) | 28 (20.0%) | 0.80 | |
| Median Nodules | 8 (4.75, 14) | 7 (4, 15) | 0.88 | 6 (4,11) | 6 (4, 10.25) | 0.98 |
| Mean Nodules | 11.4 ± 11.1 | 11.6 ± 14.2 | 8.2 ± 6.0 | 8.8 ± 8.0 | ||
| Median Abscesses | 1.5 (0, 4) | 2 (0, 3) | 0.77 | 1 (0, 3) | 1 (0, 3) | 0.88 |
| Mean Abscesses | 2.7 ± 3.3 | 2.6 ± 3.6 | 2.0 ± 2.5 | 2.3 (3.2) | ||
| Median Draining Tunnels | 2.5 (0.75, 7) | 2 (0, 5) | 0.38 | 2 (0, 4) | 1 (0, 4) | 0.60 |
| Mean Draining Tunnels | 4.5 ± 5.1 | 3.7 ± 4.3 | 3.0 ± 4.0 | 3.5 ± 5.8 | ||
| Median Baseline IHS4 | 26.5 (15, 45.25) | 25.0 (12, 40) | 0.28 | 19 (10, 34) | 18 (8.75, 32.25) | 0.91 |
| Mean Baseline IHS4 | 34.7 ± 26.8 | 31.6 ± 27.9 | 24.2 ± 20.0 | 27.3 ± 29.3 | ||