TABLE 2.
Women, n (%) | 95 (54) |
Age, years, median (IQR) [range] | 36 (29‐48) [18‐70] |
Age at diagnosis, years, median (IQR) [range] | 33 (22‐42) [3‐68] |
Crohn's disease, n (%) | 97 (55) |
Ulcerative colitis, n (%) | 78 (45) |
Body weight, kg, median (IQR) [range] | 69 (60‐80) [43‐118] |
Immunomodulators | |
Pre‐treatment, n (%) | 147 (84) |
During treatment, n (%) | 80 (46) |
Corticosteroids | |
Pre‐treatment, n (%) | 106 (61) |
During treatment, n (%) | 71 (41) |
Crohn's disease activity index (n = 96), median (IQR) [range] Full Mayo clinic score (n = 73), median (IQR) [range] |
283 (249‐333) [222‐446] 8 (7‐9) [4‐11] |
Haemoglobin, g/L, median (IQR) [range] | 128 (117‐139) [43‐170] |
Platelet count, ×109/L, median (IQR) [range] | 295 (243‐366) [43‐698] |
White blood cell count, ×109/L, median (IQR) [range] | 7.1 (5.6‐9.1) [2.7‐43] |
Albumin, g/L, median (IQR) [range] | 44 (40‐46) [28‐54] |
C‐reactive protein, mg/L, median (IQR) [range] | 3.2 (1.2‐7.9) [0.2‐89.4] |
Faecal calprotectin, mg/kg, median (IQR) [range] | 749 (265‐1576) [10‐6913] |
Neutralising antibodies during treatment, n (%) | 58 (33) |
Part 1 of the study (n = 44, all with Crohn's disease) was designed to find the optimal dose of subcutaneous CT‐P13. Part 2 (n = 131, 53 with Crohn's disease, 78 with ulcerative colitis) of the study was designed to demonstrate non‐inferiority in pharmacokinetics between subcutaneous and intravenous CT‐P13.