117 Correlating IBDQ to EQ-5D Utility Scores in Risankizumab Phase 3 Ulcerative Colitis Clinical Trials
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,060 | 0,051 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,004 |
| Bibliométrie | 0,001 | 0,002 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».