S735 Mirikizumab Improves Quality of Life in Moderately-to-Severely Active UC: Improvement in IBDQ Scores in Participants of LUCENT-1 and LUCENT-2 Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials
Notice bibliographique
Résumé
Introduction: The Inflammatory Bowel Disease Questionnaire (IBDQ) is a measure of health-related quality of life (QoL). This analysis evaluated effect of mirikizumab (miri) vs placebo (PBO) on IBDQ scores in patients (pts) with moderately-to-severely active ulcerative colitis (UC) who had failed prior conventional or biologic therapy in a Phase 3, double-blind, 12-week (W) induction study (LUCENT-1) followed by a 40W maintenance study (LUCENT-2) for a total of 52W continuous therapy. Methods: Pts (N=1162) in LUCENT-1 were randomized 3:1 to receive 300mg miri or PBO intravenously once every four weeks (Q4W). 544 pts who achieved Modified Mayo Score Clinical Response to miri by W12 of induction were rerandomized 2:1 in LUCENT-2 to subcutaneous miri 200mg or PBO Q4W in maintenance period. Randomization was stratified by previous biologic therapy failure, baseline corticosteroid use, and region. LUCENT-1 stratification included baseline (BL) disease activity, and LUCENT-2 included LUCENT-1 clinical remission status. The least squares mean change from BL in IBDQ scores at W12 of induction and W40 of maintenance was determined using analysis of covariance models. BL was W0 of therapy and stratification factors and BL scores were used as covariates. The Minimal Clinically Important Difference (MCID) was defined as an improvement of ≥16 points in total IBDQ score (IBDQ response) and IBDQ remission as a total score ≥170 points. IBDQ response and remission were calculated using non-responder imputations. Treatments were compared using the common risk difference (risk diff). Results: Miri treatment resulted in significantly greater improvement from BL in IBDQ total and domain scores vs PBO at both W12 of induction and W40 of maintenance (52W treatment) (Table). The proportions of pts who achieved an IBDQ response was significantly greater for miri treated pts vs PBO at W12 (risk diff =17.1[95%CI:10.7, 23.5]) and W40 (29.5 [21.0, 37.9]). Significantly greater proportions of pts receiving miri achieved IBDQ remission at W12 (18.1 [11.8, 24.4]) and W40 (28.5 [20.1, 37.0]) vs PBO (all evaluations and timepoints: p< 0.001). Conclusion: Pts reported significantly greater improvements in IBDQ scores at induction and maintenance with miri compared to PBO. Over 75% of pts achieved a clinically meaningful improvement in QoL, as measured by IBDQ response, at the end of the 52 weeks of miri treatment. Table 1. - LUCENT-1 and LUCENT-2 Trials Change from Baseline in the Inflammatory Bowel Disease Questionnaire IBDQ Total Score 1 IBDQ Response 2 Score Improvement ≥16 IBDQ Remission 2 IBDQ Total Score ≥170 LSM Change from BL (SE) LSM Diff (SE) n (%) Risk Diff (95% CI) n (%) Risk Diff (95% CI) LUCENT-1 Week 12 of Induction PBO IV Q4W (N=294) 25.21 (1.80) 164 (55.8) 117 (39.8) Miri 300 mg IV Q4W (N=868) 38.42 (1.11) 13.21 (2.01)* 631 (72.7) 17.1 (10.7, 23.5)* 499 (57.5) 18.1 (11.8, 24.4)* LUCENT-2 Week 40 of Maintenance (52 Weeks of Continuous Therapy) of Miri Induction Responders PBO SC (N=179) 24.51 (2.77) 88 (49.2) 77 (43.0) Miri 200 mg SC (N=365) 49.75 (2.10) 25.24 (3.09)* 289 (79.2) 29.5 (21.0, 37.9)* 264 (72.3) 28.5 (20.1, 37.0)* Abbreviations: BL=baseline; CI=confidence interval; Diff=difference; IBDQ=Inflammatory Bowel Disease Questionnaire; IV=intravenous; LSM=least squares mean; Miri=mirikizumab; n=number of patients in the specified category; N=number of patients in the analysis population; PBO=placebo; Q4W=every 4 weeks; Risk Diff=common risk difference; SC=subcutaneous; SE=standard error.1Inflammatory Bowel Disease Questionnaire domains and total scores were evaluated by analysis of covariance with modified baseline observation carried forward and adjustment for covariates.2Inflammatory Bowel Disease Questionnaire-based measurements for clinical response and remission were analyzed using non-responder imputation. The common risk difference was the stratification-adjusted difference in the proportion of participants receiving mirikizumab minus the proportion of participants receiving placebo.*p< 0.001.
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 | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,005 | 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 ».