Patient demographics and disease characteristics at baseline
| Placebo (n=69) | 10 mg (n=67) | 50 mg (n=71) | 200 mg (n=40) | |
| Mean age, years (SD) | 38.4 (13.6) | 38.9 (12.9) | 38.9 (13.1) | 42.2 (13.2) |
| Female, n (%) | 38 (55.1) | 34 (50.7) | 44 (62.0) | 25 (62.5) |
| Mean body mass index, kg/m2 (SD) | 25.8 (7.4) | 24.8 (5.7) | 25.0 (6.0) | 22.9 (4.6) |
| Median disease duration, years (range) | 10.0 (1.2–36.0) | 11.0 (0.7–49.0) | 9.8 (0.3–43.0) | 11.5 (0.3–39.0) |
| Mean CDAI score* (SD) | 320.7 (64.2) | 319.9 (61.9) | 296.7 (63.3) | 337.4 (73.4) |
| Median CRP levels, mg/L (range) | 20.4 (0.1–114.7) | 16.4 (0.1–139.8) | 21.1 (1.4–106.3) | 32.2 (1.0–88.4) |
| Prior anti-TNF exposure, n (%) | ||||
| Relapsed after at least one anti-TNF | 37 (53.6) | 33 (49.3) | 34 (47.9) | 18 (45.0) |
| Primary non-responder to at least one anti-TNF | 16 (23.2) | 15 (22.4) | 14 (19.7) | 10 (25.0) |
| Intolerant to at least one anti-TNF | 11 (15.9) | 15 (22.4) | 18 (25.4) | 9 (22.5) |
| Discontinued anti-TNF for other reason† | 5 (7.2) | 4 (6.0) | 5 (7.0) | 3 (7.5) |
| Current use of immunosuppressive therapy, n (%) | ||||
| Azathioprine | 10 (14.5) | 10 (14.9) | 13 (18.3) | 5 (12.5) |
| 6-Mercaptopurine | 2 (2.9) | 2 (3.0) | 3 (4.2) | 1 (2.5) |
| Methotrexate | 4 (5.8) | 8 (11.9) | 7 (9.9) | 2 (5.0) |
| No immunosuppressive therapy | 53 (76.8) | 47 (70.1) | 48 (67.6) | 32 (80.0) |
| Current use of corticosteroids, n (%; median dose) | 35 (50.7; 20 mg) | 17 (25.4; 15 mg) | 29 (40.8; 20 mg) | 19 (47.5; 20 mg) |
| Presence of ulcers, n (%) | 69 (100) | 66 (98.5) | 71 (100) | 40 (100) |
| Sites of involvement | ||||
| Ileum | 40 (58) | 48 (71.6) | 33 (46.5) | 27 (67.5) |
| Right colon | 34 (49.3) | 25 (37.3) | 28 (39.4) | 19 (47.5) |
| Transverse colon | 30 (43.5) | 23 (34.3) | 34 (47.9) | 21 (52.5) |
| Left colon | 46 (66.7) | 32 (47.8) | 50 (70.4) | 29 (72.5) |
| Rectum | 38 (55.1) | 30 (44.8) | 47 (66.2) | 23 (57.5) |
| SES-CD subscores, mean (SD) | ||||
| Ileum | 3.9 (3.5) (n=67) | 4.4 (3.4) (n=66) | 3.6 (3.8) (n=68) | 4.6 (3.7) (n=40) |
| Right colon | 3.0 (3.4) (n=66) | 2.2 (2.7) (n=66) | 2.2 (2.8) (n=67) | 2.8 (3.2) (n=39) |
| Transverse colon | 2.5 (3.1) (n=68) | 2.0 (2.9) (n=67) | 2.8 (3.3) (n=70) | 3.4 (3.4) (n=39) |
| Left colon | 4.0 (3.4) (n=69) | 3.2 (3.6) (n=67) | 4.6 (3.3) (n=70) | 5.1 (3.8) (n=40) |
| Rectum | 3.4 (3.4) (n=69) | 3.1 (3.5) (n=67) | 4.1 (3.4) (n=71) | 3.8 (3.7) (n=40) |
*The mean baseline CDAI score was different between the 50 mg and placebo groups, and this difference was statistically significant.
†This category captures discontinuations unrelated to efficacy or safety and may include financial/insurance-based issues to continuing the treatment.
CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein; SES-CD, Simple Endoscopic Score for CD; TNF, tumour necrosis factor.