Baseline characteristics
| PF-00547659 | ||||
| Placebo(n=63) | 22.5 mg (n=66) | 75 mg (n=65) | 225 mg (n=68) | |
| Age (years), mean (SD) | 34.4 (11.1) | 37.3 (13.0) | 34.4. (10.7) | 35.9 (11.0) |
| Females, n (%) | 30 (47.6) | 48 (72.7) | 35 (53.8) | 43 (63.2) |
| Race, n (%) | ||||
| White | 54 (85.7) | 53 (80.3) | 53 (81.5) | 60 (88.2) |
| Black | 1 (1.6) | 2 (3.0) | 2 (3.1) | 2 (2.9) |
| Asian | 5 (7.9) | 8 (12.1) | 8 (12.3) | 6 (8.8) |
| Other | 3 (4.8) | 3 (4.5) | 2 (3.1) | 0 |
| Weight (kg), mean (SD) | 70.1 (19.4) | 71.9 (17.5) | 69.5 (21.5) | 69.6 (20.9) |
| Smoking status, n (%) | ||||
| Never smoked | 29 (46.0) | 26 (39.4) | 29 (44.6) | 32 (47.1) |
| Ex-smoker | 15 (23.8) | 18 (27.3) | 15 (23.1) | 15 (22.1) |
| Smoker | 19 (30.2) | 22 (33.3) | 21 (32.3) | 21 (30.9) |
| Disease duration, years, mean | 11.5 | 12.7 | 11.4 | 12.0 |
| SES-CD total score* (severity), mean (SD) | 19.3 (11.1) | 19.1 (9.0) | 17.4 (8.8) | 15.7 (9.0) |
| Site of colonoscopic abnormality, n (%) | ||||
| Ileum | 40 (63.5) | 38 (57.6) | 40 (61.5) | 43 (63.2) |
| Right colon | 40 (63.5) | 34 (51.5) | 36 (55.4) | 25 (36.8) |
| Transverse colon | 36 (57.1) | 37 (56.1) | 34 (52.3) | 27 (39.7) |
| Left colon | 43 (68.3) | 49 (74.2) | 45 (69.2) | 42 (61.8) |
| Rectum | 41 (61.5) | 49 (74.2) | 40 (61.5) | 44 (64.7) |
| Fistulising disease, n (%) | 14 (22.2) | 15 (22.7) | 19 (29.2) | 15 (22.1) |
| hsCRP* (mg/L), median (range) | 18.9 (2.3–240.9) | 21.1 (1.3–178.0) | 14.6 (0.3–180.1) | 17.2 (2.4–117.3) |
| Faecal calprotectin* (µg/g), median (range) | 1797 (179–27,545) | 1705 (97–18,323) | 1389 (23–10,977) | 1346 (134–31,588) |
| Central memory CD4+T cells MESF, median (range) | 638.5 (117–2647) | 670.0 (45–1669) | 877.5 (260–2402) | 660.5 (193–2252) |
| CDAI score*, mean (SD) | 313.1 (61.4) | 307.4 (71.1) | 324.1 (63.1) | 316.4 (64.6) |
| Prior treatment strata, n (%) | ||||
| Relapsed after ≥1 anti-TNF-α | 34 (54.0) | 34 (51.5) | 37 (56.9) | 39 (57.4) |
| No response to ≥1 anti-TNF-α | 12 (19.0) | 13 (19.7) | 11 (16.9) | 11 (16.2) |
| Intolerant to ≥1 anti-TNF-α | 12 (19.0) | 13 (19.7) | 12 (18.5) | 13 (19.1) |
| Failure/intolerance to any IS | 5 (7.9) | 6 (9.1) | 5 (7.7) | 5 (7.4) |
| Current use of IS therapy, n (%) | ||||
| Azathioprine | 13 (20.6) | 11 (16.7) | 15 (23.1) | 15 (22.1) |
| 6-Mercaptopurine | 2 (3.2) | 6 (9.1) | 6 (9.2) | 4 (5.9) |
| Methotrexate | 6 (9.5) | 10 (15.2) | 7 (10.8) | 7 (10.3) |
| No IS therapy | 42 (66.7) | 39 (59.1) | 37 (56.9) | 42 (61.8) |
| Current use of steroids, n (%) | 29 (46.0) | 31 (47.0) | 36 (55.4) | 35 (51.5) |
*Data not available from all patients; therefore, n values may be smaller than for the total population.
CDAI, Crohn’s Disease Activity Index; hsCRP, high-sensitivity C reactive protein; IS, immunosuppressive; MESF, molecules of equivalent soluble fluorochrome; SD, standard deviation; SES-CD, Simple Endoscopic Activity Score; TNF, tumour necrosis factor.