Table 2.
Comparison of Clinical Characteristics and Outcomes Between the Bionaïve and Biologic-Exposed
| Outcomes | Bionaïve (n = 26) | Biologic-Exposed (n = 101) | P |
|---|---|---|---|
| Gender, female, n (%) | 9 (34.6) | 51 (50.5) | 0.126 |
|
Median age at baseline, years, SD Disease duration, years, SD |
45.4 (15.1) 8.1 (6.9) |
37.0 (14.1) 10.2 (7.4) |
0.521 0.799 |
| Severe disease, n (%) | 6 (23.1) | 38 (37.6) | 0.103 |
| Clinical response at week 12–16, n (%) | 16 (61.5) | 70 (69.3) | 0.548 |
| Clinical remission at week 12–16, n (%) | 8 (30.8) | 32 (31.7) | 0.487 |
| Clinical response at 6 months, n (%) | 17 (65.4) | 63 (62.4) | 0.677 |
| Clinical remission at 6 months, n (%) | 13 (50.0) | 46 (45.5) | 0.401 |
| Clinical remission at 1 year, n (%) | 14 (53.8) | 33 (32.7) | 0.005 |
| Endoscopic response within 1 year, n (%) | 14 (53.8) | 43 (43.9) | 0.134 |
| Mucosal healing within 1 year, n (%) | 5 (19.2) | 14 (14.3) | 0.690 |
| Steroids at baseline, n (%) | 15 (57.7) | 90 (89.1) | 0.007 |
| SFCR* at week 12–16, n (%) | 4 (26.6) | 28 (31.1) | 0.423 |
| SFCR* at 1 year, n (%) | 8 (53.3) | 30 (33.3) | 0.076 |
| Higher biomarkers at baseline, n (%) | 24 (92.3) | 92 (91.1) | 0.823 |
| Biochemical response at weeks 12–16, n (%) | 14 (58.3) | 46 (50.0) | 0.441 |
| Biochemical remission 6 months, n (%) | 10 (41.7) | 29 (31.5) | 0.138 |
| Biochemical remission 1 year, n (%) | 8 (33.3) | 26 (28.3) | 0.595 |
| Nonprimary response, n (%) | 4 (15.4) | 14 (13.9) | 0.791 |
|
Loss of response, n (%) Need of optimization, n (%) |
6 (23.1) 7 (26.9) |
23 (22.8) 47 (46.5) |
0.822 0.048 |
| Treatment interruption, n (%) | 7 (26.9) | 28 (27.7) | 0.754 |
| Need of hospitalization, n (%) | 0 (0.0) | 13 (12.9) | 0.016 |
| Need of colectomy, n (%) | 0 (0.0) | 10 (9.9) | 0.036 |
*SFCR (steroid-free clinical remission)