Table 1.
Baseline demographics and disease characteristics
| Induction study |
Maintenance study |
||||||
|---|---|---|---|---|---|---|---|
| Placebo N=91 |
Tofacitinib 5 mg twice daily N=86 |
Tofacitinib 10 mg twice daily N=86 |
Tofacitinib 15 mg twice daily N=16 |
Placebo N=59 |
Tofacitinib 5 mg twice daily N=60 |
Tofacitinib 10 mg twice daily N=61 |
|
| Treatment group in the induction study | |||||||
| n (%) | |||||||
| Placebo | 17 (28.8) | 17 (28.3) | 18 (29.5) | ||||
| Tofacitinib 5 mg twice daily | – | – | – | – | 20 (33.9) | 21 (35.0) | 21 (34.4) |
| Tofacitinib 10 mg twice daily | 18 (30.5) | 18 (30.0) | 19 (31.1) | ||||
| Tofacitinib 15 mg twice daily | 4 (6.8) | 4 (6.7) | 3 (4.9) | ||||
| Female | |||||||
| n (%) | 60 (65.9) | 32 (37.2) | 47 (54.7) | 7 (43.8) | 32 (54.2) | 30 (50.0) | 24 (39.3) |
| Age, years | |||||||
| Mean (SD) | 37.2 (11.7) | 40.2 (11.5) | 39.3 (13.7) | 41.3 (14.3) | 41.5 (12.8) | 38.1 (11.9) | 39.0 (13.1) |
| Weight, kg | |||||||
| Mean (SD) | 69.5 (19.2) | 72.2 (20.4) | 71.6 (18.8) | 71.7 (19.7) | 75.1 (20.5) | 68.2 (16.1) | 75.0 (19.6) |
| Race | |||||||
| n (%) | |||||||
| White | 78 (85.7) | 71 (82.6) | 72 (83.7) | 8 (50.0) | 44 (74.6) | 50 (83.3) | 50 (82.0) |
| Black | 6 (6.6) | 1 (1.2) | 2 (2.3) | 2 (12.5) | 3 (5.1) | 0 (0) | 3 (4.9) |
| Asian | 5 (5.5) | 12 (14.0) | 11 (12.8) | 6 (37.5) | 10 (16.9) | 9 (15.0) | 8 (13.1) |
| Others | 2 (2.2) | 2 (2.3) | 1 (1.2) | 0 (0) | 2 (3.4) | 1 (1.7) | 0 (0) |
| Duration since CD diagnosis, years | |||||||
| Mean (SD) | 10.9 (8.6) | 11.2 (8.2) | 11.3 (9.7) | 11.1 (8.6) | 12.5 (9.3) | 11.2 (8.3) | 12.6 (10.0) |
| Prior surgery for CD* | |||||||
| n (%) | 38 (41.8) | 46 (53.5) | 41 (47.7)† | 6 (37.5) | 26 (44.1) | 34 (56.7) | 25 (41.0)† |
| Extent of disease | |||||||
| n (%) | |||||||
| L1 (I/TI) | 10 (11.0) | 14 (16.3) | 7 (8.1) | 1 (6.3) | 6 (10.2) | 6 (10.0) | 5 (8.2) |
| L14 (I/TI+UGI) | 4 (4.4) | 3 (3.5) | 2 (2.3) | 0 (0.0) | 2 (3.4) | 3 (5.0) | 1 (1.6) |
| L2 (C) | 5 (5.5) | 4 (4.7) | 5 (5.8) | 2 (12.5) | 4 (6.8) | 3 (5.0) | 3 (4.9) |
| L24 (C+UGI) | 18 (19.8) | 12 (14.0) | 16 (18.6) | 1 (6.3) | 9 (15.3) | 11 (18.3) | 10 (16.4) |
| L3 (IC) | 25 (27.5) | 12 (14.0) | 15 (17.4) | 3 (18.8) | 15 (25.4) | 13 (21.7) | 13 (21.3) |
| L34 (IC+UGI) | 29 (31.9) | 41 (47.7) | 39 (45.3) | 9 (56.3) | 23 (39.0) | 24 (40.0) | 28 (45.9) |
| L4 (UGI) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Missing | 0 (0.0) | 0 (0.0) | 2 (2.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.6) |
| Prior use of TNFi | |||||||
| n (%) | 70 (76.9) | 68 (79.1) | 66 (76.7) | 11 (68.8) | 39 (66.1) | 48 (80.0) | 48 (78.7) |
| Use of corticosteroids at study entry | |||||||
| n (%) | 35 (38.5) | 32 (37.2) | 28 (32.6) | 4 (25.0) | 18 (30.5)‡ | 18 (30.0)‡ | 23 (37.7)‡ |
| Baseline CDAI score | |||||||
| Mean (SD) | 313 (67.14)§ | 314 (53.06)§ | 320 (61.66)§ | 328 (76.66)§ | 140 (74.16)¶ | 131 (60.51)¶ | 129 (61.34)¶ |
| Baseline CRP, mg/L | |||||||
| Median (min–max) | 5.5 (0.3–246)** | 5.9 (0.3–95.2)** | 5.5 (0.2–126)** | 20.0 (0.4–47.2)** | 3.7 (0.1–65.3) | 2.7 (0.1–95.2) | 3.2 (0.1–102) |
| Baseline FCP, mg/kg | |||||||
| Median (min–max) | 246 (25.2–1135)†† | 398 (25.2–4746)†† | 430 (25.2–2735)†† | 363 (25.2–1114)†† | 212 (25.2–1133) | 277 (25.2–1043) | 322 (25.2–1154) |
Safety analysis set of the induction and maintenance studies; unless stated otherwise, baseline information at induction study entry is provided.
*Including bowel resection.
†One subject with missing data.
‡Baseline information at maintenance study entry.
§Based on N=91, 85, 86 and 16 for placebo, tofacitinib 5, 10 and 15 mg twice daily, respectively.
¶At week 8 of induction study.
**Based on N=91, 84, 84 and 15 for placebo, tofacitinib 5, 10 and 15 mg twice daily, respectively.
††Based on N=81, 68, 68 and 13 for placebo, tofacitinib 5, 10 and 15 mg twice daily, respectively.
C, colon; CD, Crohn's disease; CDAI, Crohn's disease activity index; CRP, C-reactive protein; FCP, faecal calprotectin; IC, ileocolon; I/TI, ileum and/or terminal ileum; TNFi, tumour necrosis factor inhibitor; UGI, upper gastrointestinal tract.