P0807 Impact of Risankizumab on Patient-reported Outcomes and Biomarkers Over Time: Post-Hoc Analysis of Phase 3 INSPIRE and COMMAND Studies
Bibliographic record
Abstract
Abstract Background Patients with ulcerative colitis (UC) may experience debilitating symptoms that impact their quality of life. This post hoc analysis evaluates changes in patient-reported outcomes (PROs) and biomarkers over time during maintenance treatment with risankizumab (RZB), a specific inhibitor of IL-23, among patients who responded to RZB induction treatment. Methods Patients with a clinical response to 12 weeks of intravenous (IV) RZB treatment from the Phase 2b and Phase 3 INSPIRE induction studies were randomised 1:1:1 to subcutaneous (SC) placebo (PBO) withdrawal, 180 mg RZB SC, or 360 mg RZB SC every 8 weeks during maintenance (COMMAND). Individual PROs were examined as no bowel urgency, no abdominal pain, no nocturnal bowel movements, no tenesmus, no faecal incontinence, no UC-related sleep interruption, and no fatigue (Functional Assessment of Chronic Illness-Fatigue [FACIT-F] ≥ 40). Biomarkers examined were faecal calprotectin (FCP) and high-sensitivity C-reactive protein (hs-CRP). Results were reported as the percentage of patients achieving each outcome for all PROs and median values for biomarkers at Week (wk) 0 of induction and every 8 wks from wk 0–52 of maintenance, unless otherwise stated for FACIT-F ≥ 40.1, hs-CRP and FCP. Non-responder imputation with no special data handling for missing data due to logistic restrictions (COVID-19 or the geo-political conflict in Ukraine and surrounding impacted regions) was used for missing data. Results In total, 548 patients (PBO SC, n=183; RZB 180 mg SC, n=179; RZB 360 mg SC, n=186) were randomised into the maintenance study. A higher proportion of patients achieved PROs at maintenance wk 0 compared to the induction baseline (Figures 1 and 2). Throughout maintenance, achievement of PROs persisted in patients receiving RZB, regardless of dosage, except for no nocturnal bowel movements, no fecal incontinence, and no UC-related sleep interruption, which showed a slight decrease in response for all treatment groups. A decline in achievement of all PROs in the PBO withdrawal arm was seen from wk 32 onwards. Both biomarkers showed a decrease in median levels from induction wk 0 to maintenance wk 0. During maintenance, median FCP levels were lower for both RZB doses compared to PBO. Lower median hs-CRP levels persisted during maintenance but were similar among all treatment groups. Conclusion Improvements in most PROs and biomarkers were sustained throughout maintenance, with declines seen in the PBO maintenance group likely due to the withdrawal of RZB from RZB induction treatment. These findings show that RZB may decrease common UC-related symptoms and may improve patients’ quality of life and inflammatory burden.
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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 | 0.043 | 0.033 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.010 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".