TABLE 1:
Differences between Responders and Non-Responders at 90 days
| Variable | All Patients (n,%) n = 81 | NonResponders (n,%) n = 47 (58%) | Responders (n,%) n = 34 (42%) | P value |
|---|---|---|---|---|
| Age [mean in years (SD)] | 33.5 (11) | 32 (12) | 35 (10) | 0.29 |
| Female gender [n (%)] | 31 (38) | 16 (34) | 15 (44) | 0.36 |
| First Ciclosporin level [median in ng/mL (IQR)] | 264 (149) | 129.18 (149) | 264 (178) | 0.9 |
| Mean Ciclosporin level [median in ng/mL (IQR)] | 278 (117) | 278 (112) | 278 (133) | 0.94 |
| Peak Ciclosporin level [median in ng/mL (IQR)] | 418 (141) | 430 (143) | 403 (165) | 0.83 |
| CRP [mean in mg/L (SD)] | 30 (33) | 38 (37) | 20 (29) | 0.01* |
| White blood cell count [mean in mcL (SD)] | 9633 (4135) | 7135 (4786) | 8920 (3690) | 0.32 |
| Platelet count [mean in 103/mL (SD)] | 318 (114) | 315(129) | 323(91) | 0.75 |
| Albumin level [mean in g/dL (SD)] | 3.6 (0.8) | 3.7 (0.7) | 3.4 (0.8) | 0.03* |
| Active smoker [n (%)] | 11 (14) | 5 (10.6) | 6 (17.6) | 0.37 |
| Deep colonic ulcers [n (%)] | 25 (31) | 16 (34) | 9 (26.5) | 0.43 |
| Kidney injury [n (%)] | 25 (31) | 8 (17) | 17 (50) | 0.002* |
| Priora Anti-tumor necrosis factor agent use (Anti-TNF) [n (%)] | 13 (16) | 2 (4.3) | 11 (32.4) | <0.0001* |
| Priora immunomodulators use [n (%)] | 54 (67) | 33 (70.2) | 21 (61.8) | 0.43 |
| Priora Clostridium difficle infection [n (%)] | 9 (11) | 4 (8.5) | 5 (14.7) | 0.39 |
| Priora Cytomegalovirus (CMV) infection [n (%)] | 4 (5) | 3 (6.4) | 1 (2.9) | 0.47 |
| Pancolitis [n (%)] | 62 (77) | 44 (93.6) | 18 (52.9) | .0001* |
| Disease Duration [mean, years (SD)] | 4.49 (6.34) | 4.25 (6.32) | 4.29 (4.98) | 0.97 |
a “Prior” refers to use of anti-TNF agents, immunomodulators, or infection with clostridium difficle or CMV at any time point before IV ciclosporin administration.