P373 Effect of risankizumab on improved and sustained quality of life in patients with moderate to severe Crohn’s disease: Phase 2 trial results
Bibliographic record
Abstract
Risankizumab (RZB), an anti-interleukin 23 antibody, is being investigated as a treatment for Crohn’s disease (CD). The impact of RZB on health-related quality of life, measured by Inflammatory Bowel Disease Questionnaire (IBDQ), was assessed in the Phase 2 trial of RZB in CD (NCT02031276). Adults (18–75 years) with moderate to severe CD (CDAI 220–450 with mucosal ulcers and CDEIS ≥7 [or ≥4 in patients with isolated ileitis on ileocolonoscopy]) were enrolled. In the double-blind phase (weeks [weeks] 0–12, period 1), patients received RZB (200 mg or 600 mg) or placebo (PBO) IV Q4W for 12 weeks as induction therapy. In the extended induction/washout phase (Weeks 14–26, period 2), those not in deep remission at Week 12 received open-label RZB 600 mg IV Q4W for 12 weeks and those in deep remission at Week 12 entered a washout phase until Week 26. Pts in clinical remission at Week 26 entered the maintenance phase and received open-label RZB 180 mg SQ Q8W for 26 weeks (Weeks 26–52, period 3); those not in clinical remission discontinued. In period 2 and 3, only patients who received open-label RZB treatment were analysed. Percentages of patients with IBDQ response (increase in IBDQ total score ≥16); IBDQ remission (IBDQ total score ≥170); and mean change from baseline (BL) in IBDQ total, domain, and selected individual item scores were calculated at Weeks 12, 26, and 52. Data from 121 patients were analysed in period 1. At Week 12, the percentage of patients with IBDQ response was significantly greater (p < 0.05) in both RZB groups vs. PBO (Table 1). A potential dose–response was observed at Week 12 with greater improvements seen in RZB 600 mg and 200 mg vs. PBO in IBDQ total score, domain scores (Table 2), and item scores from BL including bowel movement frequency, abdominal pain, rectal bleeding, stomach sick, and fatigue (all p < 0.05). During period 2, patients receiving extended induction therapy gained additional improvement in IBDQ outcomes at Week 26 vs. Week 12, especially those receiving PBO in period 1. These improvements in IBDQ outcomes were maintained at Week 52 of RZB treatment. Table 1. Patients with IBDQ response and remission at Weeks 12, 26, and 52 (NRI). Table 2. Mean change from baseline in IBDQ total and domain scores (LOCF). In patients with CD, induction treatment with RZB 200 mg or 600 mg IV Q4W led to significant and dose–response improvements in IBDQ outcomes at Week 12. Additional improvement in IBDQ outcomes was observed with extended induction therapy. The treatment benefit of RZB in IBDQ was maintained by Week 52.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 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".