TABLE 1.
Baseline Characteristics: Tofacitinib vs Ustekinumab
| Characteristics* | Tofacitinib (n = 45) | Ustekinumab (n = 36) | P † |
|---|---|---|---|
| Female, fraction (%) | 25/45 (55.6) | 19/36 (52.8) | 0.83 |
| Age, y, mean (SD) | 44.2 (14.9) | 41.7 (11.5) | 0.42 |
| UC duration, y, mean (SD) | 10.6 (5.9) | 13.6 (8.6) | 0.06 |
| BMI, mean (SD) | 25.7 (5.8) | 25.6 (5.5) | 0.92 |
| Race, fraction (%) | 0.48 | ||
| White | 41/45 (91.1) | 33/36 (91.7) | |
| Black | 2/45 (4.4) | 0/36 (0.0) | |
| Asian | 2/46 (4.4) | 3/36 (8.3) | |
| Disease extent, fraction (%) | 0.91 | ||
| Proctitis | 1/45 (2.2) | 1/36 (2.8) | |
| Left-sided | 18/45 (40.0) | 13/36 (36.1) | |
| Pancolitis | 26/45 (57.8) | 22/36 (61.1) | |
| Last Mayo endoscopic subscore, fraction (%) | 0.42 | ||
| Normal or mild (≤1) | 7/45 (15.6) | 11/36 (30.6) | |
| Moderate (2) | 24/45 (53.3) | 16/36 (44.4) | |
| Severe (3) | 14/45 (31.1) | 9/36 (26.0) | |
| Extraintestinal manifestation, fraction (%) | 15/45 (33.3) | 16/36 (44.4) | 0.36 |
| >2 prior biologics, fraction (%) | 29/45 (64.4) | 17/36 (47.2) | 0.18 |
| >3 prior biologics, fraction (%) | 8/45 (17.8) | 6/36 (16.7) | 1.00 |
| Prior immunomodulator,‡ fraction (%) | 37/45 (82.2) | 28/36 (77.8) | 0.78 |
| Current immunomodulator, fraction (%) | 1/45 (2.2) | 8/36 (22.2) | <0.01 |
| Current corticosteroids,§ fraction (%) | 25/45 (55.6) | 23/36 (63.9) | 0.50 |
| Current smoking, fraction (%) | 2/45 (4.4) | 0/36 (0.0) | 0.50 |
| Current cannabis, fraction (%) | 4/45 (8.9) | 5/36 (13.9) | 0.50 |
| Current opioids, fraction (%) | 3/45 (6.7) | 3/36 (8.3) | 1.00 |
| SCCAI, mean (SD) | 6.1 (5.2) | 5.3 (4.3) | 0.25 |
| Laboratory values | |||
| Albumin, mean (SD), g/dL | 4.0 (0.4) | 4.1 (0.4) | 0.18 |
| C-reactive protein, mean (SD), mg/L, n = 45, 35 | 16.1 (26.6) | 12.4 (25.3) | 0.54 |
| Fecal calprotectin, median (IQR), µg/g, n = 13, 13 | 435 (320-940.3) | 604 (214-1394.4) | 0.86 |
Denominators for outcomes vary because of unavailable data.
*Baseline characteristics represent the most recent clinical data available within 3 months before ustekinumab initiation.
† Calculated using Student t test, Wilcoxon rank sum test, or Fisher exact test.
‡Includes azathioprine, 6-mercaptopurine, and methotrexate.
§Includes prednisone, methylprednisolone, and oral budesonide preparations.
BMI indicates body mass index; IQR, interquartile range.