Symptom Resolution and Meaningful Improvement in Quality of Life With Risankizumab in Patients With Ulcerative Colitis: Post Hoc Analysis of the Randomized INSPIRE and COMMAND Studies
Bibliographic record
Abstract
INTRODUCTION: Patients with ulcerative colitis (UC) experience disruptive symptoms that can impair quality of life (QoL). This study examined the effect of risankizumab (RZB) induction and maintenance treatment on symptom resolution and health-related QoL (HRQoL) outcomes. METHODS: For the 12-week induction, patients were randomized to intravenous (IV) RZB 1,200 mg (RZB1200) or placebo (PBO). For the 52-week maintenance, clinical responders to induction were rerandomized to subcutaneous (SC) RZB 180 mg (RZB180), RZB 360 mg (RZB360), or PBO (RZB withdrawal). This post hoc analysis assessed individual and comprehensive resolution of UC-related symptoms and clinically meaningful within-person changes (MWPCs) for HRQoL outcomes. RESULTS: RZB improved symptomatic outcomes compared with PBO at week 4 (nominal P ≤ 0.001; abdominal pain, bowel urgency, fecal incontinence [nominal P ≤ 0.01]) through the 12-week induction ( P ≤ 0.001; abdominal pain [ P ≤ 0.01]; fecal incontinence, sleep interruption [nominal P ≤ 0.001]). Greater improvements were achieved with RZB compared with PBO (RZB withdrawal) for symptomatic outcomes through the 52-week maintenance. More patients treated with RZB achieved comprehensive symptom resolution (complete resolution of all 6 UC-related symptoms) compared with PBO at week 12 of induction (RZB1200, 21.8%; PBO, 9.5% [nominal P ≤ 0.001]) and week 52 of maintenance (RZB180, 23.5%; RZB360, 19.4%; PBO [RZB withdrawal], 14.2%; nominal P ≤ 0.05 and P = 0.1358, respectively). RZB compared with PBO improved MWPCs across HRQoL outcomes at week 12 of induction (nominal P ≤ 0.001; work time missed [nominal P = 0.0033]). At week 52 of maintenance, RZB180 compared with PBO (RZB withdrawal) improved MWPCs across HRQoL outcomes (nominal P ≤ 0.001; overall work impairment [nominal P ≤ 0.01], work time missed [nominal P = 0.3324], impairment while working [nominal P ≤ 0.05]) and more patients treated with RZB360 achieved MWPCs for the Ulcerative Colitis Symptom Questionnaire, Inflammatory Bowel Disease Questionnaire, and the 36-Item Short-Form Survey Physical Component Summary (all nominal P ≤ 0.05). DISCUSSION: RZB treatment improved UC-related symptoms and HRQoL outcomes compared with PBO in patients with UC.
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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 | 0.027 | 0.022 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.007 |
| Bibliometrics | 0.001 | 0.001 |
| 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) | 0.004 | 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".