Table 3.
Univariate and multivariate analysis models for prediction of primary study outcomes and clinical remission at week 54
| Univariate | Multivariate | |||||||
|---|---|---|---|---|---|---|---|---|
| OR | 95% C.I. for OR | P | OR | 95% C.I. for OR | P | |||
| Response W14 | ||||||||
| Tonsillectomy | 0.286 | 0.09 | 0.905 | 0.033 | 0.213 | 0.043 | 1.06 | 0.059 |
| Indication | ||||||||
| Cs refractory | 0.166 | 0.032 | 0.853 | 0.032 | 0.106 | 0.016 | 0.705 | 0.02 |
| Cs dependent | 1.896 | 0.34 | 10.571 | 0.466 | 1.79 | 0.257 | 12.483 | 0.557 |
| IM refractory | 0.925 | 0.218 | 3.922 | 0.916 | 1.161 | 0.216 | 6.227 | 0.862 |
| Anti-TNF refractory | 0.127 | 0.034 | 0.475 | 0.002 | 0.16 | 0.032 | 0.796 | 0.025 |
| Concomitant cs | 1.403 | 0.528 | 3.729 | 0.498 | 1.344 | 0.382 | 4.732 | 0.646 |
| Concomitant 5-asa | 3.382 | 1.279 | 8.94 | 0.014 | 1.384 | 0.393 | 4.874 | 0.613 |
| PLT/1000 | 0.996* | 0.992 | 0.999 | 0.024 | 0.998 | 0.993 | 1.003 | 0.51 |
| Drug continuation W54 | ||||||||
| Indication | ||||||||
| Cs refractory | 0.309 | 0.073 | 1.308 | 0.111 | 0.198 | 0.04 | 0.98 | 0.047 |
| Cs dependent | 0.736 | 0.213 | 2.543 | 0.628 | 0.529 | 0.134 | 2.096 | 0.365 |
| IM refractory | 2.013 | 0.512 | 7.908 | 0.316 | 1.136 | 0.255 | 5.06 | 0.867 |
| Anti-TNF refractory | 0.56 | 0.182 | 1.722 | 0.312 | 0.377 | 0.107 | 1.329 | 0.129 |
| Concomitant cs | 0.651 | 0.222 | 1.905 | 0.433 | 0.685 | 0.107 | 1.329 | 0.505 |
| Concomitant AZA | 7.173 | 0.896 | 57.43 | 0.063 | 8.455 | 0.906 | 78.88 | 0.061 |
| Clinical remission W54 | ||||||||
| Articular EIMs | 0.397 | 0.162 | 0.974 | 0.044 | 0.288 | 0.092 | 0.901 | 0.032 |
| Indication | ||||||||
| Cs refractory | 0.23 | 0.054 | 0.98 | 0.047 | 0.171 | 0.029 | 0.997 | 0.05 |
| Cs dependent | 0.369 | 0.114 | 1.195 | 0.096 | 0.255 | 0.062 | 1.047 | 0.058 |
| IM refractory | 1.052 | 0.329 | 3.361 | 0.932 | 1.172 | 0.321 | 4.726 | 0.81 |
| Anti-TNF refractory | 0.234 | 0.077 | 0.704 | 0.01 | 0.26 | 0.065 | 1.047 | 0.058 |
| Concomitant cs | 1.148 | 0.471 | 2.798 | 0.761 | 1.201 | 0.411 | 4.897 | 0.738 |
| Concomitant 5-asa | 2.341 | 0.94 | 5.51 | 0.052 | 1.597 | 0.521 | 3.507 | 0.468 |
| PROs | ||||||||
| UC-PRO1 | 1.213* | 0.47 | 3.104 | 0.498 | 1.474 | 0.782 | 2.778 | 0.231 |
| UC-PRO2 | 0.472* | 0.276 | 0.806 | 0.006 | 0.422 | 0.231 | 0.768 | 0.005 |
Cs corticosteroids, IM immunomodulators, PLT platelets, AZA azathioprine, EIMs extra-intestinal manifestations, OR odds ratio, CI confidence interval, PROs patient-reported outcomes, UC-PRO1 rectal bleeding, UC-PRO2 stool frequency
*Concomitant use of corticosteroids was added to the model because of its effect in those variables