Effect of Risankizumab Induction and Maintenance Therapy on the Rate of Hospitalization in Patients with Crohn’s Disease
Bibliographic record
Abstract
Background and Aims In phase 3 induction (ADVANCE and MOTIVATE) and maintenance (FORTIFY) trials, risankizumab was shown to benefit symptom and endoscopic defined outcomes in patients with Crohn's disease (CD). We examined the effects of risankizumab on the incidence of CD-related hospitalizations in these studies. Methods Patients with active CD were randomized to intravenous (IV) risankizumab 600 or 1200 mg, or placebo at weeks 0, 4, and 8 in the 12-week induction studies. Clinical responders were rerandomized to maintenance with subcutaneous (SC) risankizumab 180 or 360 mg or placebo every 8 weeks for 52 weeks. Incidence of CD-related hospitalizations was compared between groups, expressed as proportions with an event during induction and event/100 person-years (PYs) during maintenance. An integrated analysis incorporated exposure time and occurrence of CD-related hospitalizations in induction and maintenance periods for labeled doses. Results The incidence of CD-related hospitalizations was lower (3.2% or 1.9% vs 11.6%; P < .01) in the risankizumab IV 600- and 1200-mg groups vs placebo IV during induction. Through 52 weeks, the incidence rate per 100 PYs of CD-related hospitalizations was similar among treatment groups, with few events reported (n = 5–9 per group). In the integrated analysis, a lower incidence rate per 100 PYs of CD-related hospitalizations was observed in the risankizumab-treated groups (600 mg IV/360 mg SC: 9.6; 600 mg IV/180 mg SC: 7.9) vs placebo (40.0, P < .001). Conclusion Risankizumab treatment resulted in reduced rates of CD-related hospitalization with treatment effect observed within 12 weeks of randomization.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".