Table 2.
Summary of primary and secondary outcomes
| Result | |
|---|---|
| Primary outcome | |
| Ustekinumab retention rate | 76.9% (95% CI, 72.8%-80.7%) Median follow-up: 15.5 mo |
| Discontinuation incidence | 18.4% per patient-year of follow-up |
| Predictive factors of discontinuation | Previous intestinal surgery, concomitant steroid treatment |
| Secondary outcomes | |
| Short-term effectiveness | |
| • Clinical remission at 8 wk | 44.0% |
| • Clinical remission at 16 wk | 56.1% |
| • Predictive factor of lower probability of remission at 16 wk | Older age, higher HBI at baseline, previous abdominal surgery |
| • Clinical response at 8 wk | 57.6% |
| • Clinical response at 16 wk | 70.2% |
| • Predictive factors of lower probability of response at 16 wk | Previous surgery |
| Long-term effectiveness | |
| • Loss of response incidence | 29.7% per patient-year of follow-up |
| • Predictive factors of higher risk of loss of response | Number of previous biologics, higher HBI at baseline, severe vs mild |
| • Probability of sustaining remission | |
| ◦ 6 mo | 84% |
| ◦ 12 mo | 74% |
| ◦ 18 mo | 66% |
| • Clinical remission at 6 mo | 57.9% |
| • Clinical remission at 18 mo | 57.2% |
| Dose optimization | |
| • Dose escalation | 4.5% |
| • Dose intensification | 21.6% |
| • Dose de-escalation | 5.8% |
Abbreviations: CI, confidence interval; HBI, Harvey-Bradshaw Index.