117 Correlating IBDQ to EQ-5D Utility Scores in Risankizumab Phase 3 Ulcerative Colitis Clinical Trials
Bibliographic record
Abstract
Background: Ulcerative colitis (UC) is a chronic inflammatory condition that substantially impacts quality of life (QoL). In Phase 3 UC trials, risankizumab (RZB) demonstrated significant improvements in patient-reported outcomes that are associated with improvements in QoL compared to placebo. Although the European Quality of Life-5 Dimensions (EQ-5D) is commonly used for health utility measurement in health technology assessments, it is a generic instrument that may not fully capture disease-specific QoL improvements. The Inflammatory Bowel Disease Questionnaire (IBDQ) is a validated disease-specific tool that is sensitive to UC-related changes in QoL, including fecal urgency and nocturnal bowel movements. This post-hoc analysis correlated IBDQ values to EQ-5D index values to better quantify the impact of RZB on UC-specific QoL impairment in patients with clinical remission or response. Methods: Data from the Phase 3 RZB M16-066 induction (NCT03398135) and M16-067 maintenance trials (NCT03398148) were used to generate linear regression equations for mapping IBDQ total score to EQ-5D (M16-066: EQ-5D = 0.1630 + 0.0037 IBDQ and M16-067: EQ-5D = 0.1955 + 0.0036 IBDQ). Ordinary least squares (LS) linear regression was performed using predicted EQ-5D values as the dependent variable and health status (active UC, clinical remission, clinical response [no remission]) as the independent variable. We measured LS mean change in EQ-5D score from induction baseline to Week 12 and from maintenance Week 0 to Week 52 in patients with clinical remission or clinical response at Week 12 or Week 52, respectively. Differences in mean change between RZB doses and placebo were calculated utilizing analysis of covariance. Data were analyzed in each Phase 3 study separately. Results: Among patients in clinical remission at the end of the 12-week induction study, mean change from baseline in predicted EQ-5D score was significantly (P = 0.046) higher for RZB 1200 mg intravenous than placebo (0.24; 95% confidence interval [CI] 0.23,0.26 vs 0.20; CI 0.17,0.24). No significant difference in mean predicted EQ-5D score was observed between RZB 1200 mg and placebo in those with a clinical response at Week 12 (0.18; CI 0.17,0.20 vs 0.19; CI 0.17,0.21). Among re-randomized induction responders in clinical remission at Week 52 of the maintenance study, mean EQ-5D score improved numerically from Week 0 by 0.03 (CI 0.01,0.06), 0.05 (CI 0.03,0.07), and 0.04 (CI 0.02,0.06) in placebo (RZB withdrawal), RZB 180 mg subcutaneous (SC), and RZB 360 mg SC treated patients, respectively. In patients with clinical response, RZB 360 mg SC had significantly greater improvement in mean EQ-5D score from Week 0, compared with placebo (RZB withdrawal) (0.01; CI -0.02,0.05 vs -0.04; CI -0.07,-0.01; P = 0.004). A significant (P = 0.025) difference was also observed between RZB 180 mg SC (-0.02; CI -0.04,-0.03) and placebo (RZB withdrawal). Conclusions: Despite similar baseline values, RZB treatment provided greater improvement in EQ-5D utility scores as derived from IBDQ scores, compared to placebo in patients with UC, suggesting superior treatment effect on QoL among patients in clinical remission. These data highlight that RZB provides benefits beyond symptom control across multiple dimensions of QoL, including physical functioning, psychological wellbeing, and social interactions – all critical components of patient experience in 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 | 0.060 | 0.051 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".