O58 Risankizumab therapy in crohn’s patients results in sustained improvements in endoscopic outcomes: FORTIFY post-hoc analysis
Bibliographic record
Abstract
Introduction This post-hoc analysis from Phase 3 Rizankizumab (RZB) studies in Crohn’s disease (CD) examined the durability of SC RZB maintenance therapy for endoscopic outcomes in patients achieving these endpoints at the end of induction. Methods Patients achieving clinical response with 12-wks IV RZB induction therapy entered the maintenance study, FORTIFY, and received either RZB SC or placebo for 52 wks. For this analysis, endoscopic outcomes in the RZB 360 mg SC (N=141) and withdrawal/placebo (PBO) (N=164) arms are reported. Maintenance of endoscopic response, endoscopic remission, and/or an SES-CD score of 0–2 were assessed at Wk52 in patients who achieved these endpoints at Wk0 of maintenance. Safety was assessed throughout. Results Following 12-wks of IV RZB induction therapy (FORTIFY Wk0), 141 patients were randomized to RZB 360 mg (patients achieving endoscopic response, 55/141; endoscopic remission, 39/141; SES-CD score of 0–2, 29/141) and 164 were randomized to withdrawal PBO (patients achieving endoscopic response, 73/164; endoscopic remission, 46/164; SES-CD 0–2, 32/164). Maintenance of endoscopic response at Wk52 was demonstrated in 70.2% (39/55) of patients receiving RZB 360 mg SC versus 38.4% (28/73) in the withdrawal PBO arm (P<0.001). Maintenance of endoscopic remission at Wk52 was demonstrated in 74.4% (29/39) of patients receiving RZB 360 mg versus 23.9% (11/46) in the withdrawal PBO SC arm (P<0.001). Maintenance of an SES-CD score from 0–2 at Wk52 was demonstrated in 65.5% (19/29) of patients receiving RZB 360 mg versus 21.9% (7/32) in the withdrawal PBO arm (P<0.001) (figure 1). RZB maintenance treatment was well-tolerated with no new safety signals observed. Conclusions RZB IV induction followed by SC maintenance therapy led to sustained improvements in endoscopic outcomes, demonstrating the durability of efficacy with RZB treatment in patients with moderate to severe CD. Figure 1: Achievement of an endpoint at Wk52 in patients who achieved the endpoint at Wk0; Endoscopic response: A decrease in SES-CD > 50% from baseline (or for subjects with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline); Endoscopic remission: SES-CD ≤ 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.
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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 | 0.008 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.008 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
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".