Table 2.
Unadjusted outcomes: composite endpoint of disease worsening requiring acute care and composite endpoint of disease worsening or treatment failure
| Infliximab-dyyb (n = 1409) | RP infliximab (n = 1409) | Non-inferiority test P value | Superiority test P value | |
|---|---|---|---|---|
| Composite endpoint of IBD worsening requiring acute carea, n (%) | 144 (10.2) | 245 (17.4) | < 0.01 | < 0.01 |
| Hospitalization | 20 (1.4) | 48 (3.4) | < 0.01 | < 0.01 |
| Emergency room visit | 141 (10.0) | 221 (15.7) | < 0.01 | < 0.01 |
| Surgery | 12 (0.9) | 57 (4.0) | < 0.01 | < 0.01 |
| Composite endpoint of IBD worsening requiring acute care or treatment failureb, n (%) | 347 (24.6) | 375 (26.6) | < 0.01 | 0.23 |
| Switching therapy | 221 (15.7) | 163 (11.6) | < 0.01 | < 0.01 |
IBD inflammatory bowel disease, RP reference product
aComposite endpoint of IBD worsening requiring acute care was defined as patients who experienced IBD-related hospitalization, emergency room visit, or surgery
bComposite endpoint of IBD worsening requiring acute care or treatment failure was defined as patients who experienced IBD-related hospitalization, emergency room visit, surgery, or switching IBD therapy