S907 Guselkumab Improves Abdominal Pain and Bowel Urgency Symptoms in Patients With Moderately to Severely Active Ulcerative Colitis: Results From the Phase 3 QUASAR Induction Study
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Résumé
Introduction: Abdominal pain and bowel urgency are prevalent, burdensome symptoms experienced by patients (pts) with ulcerative colitis (UC) that impact daily life, including social activities. In this study, we use data from the QUASAR Phase 3 Induction Study to assess efficacy of guselkumab (GUS) on abdominal pain, bowel urgency, and the impact of bowel urgency on pts’ lives. Methods: Pts were randomized 3:2 to receive IV GUS 200mg or placebo (PBO) at Weeks (Wks) 0, 4, and 8. Abdominal pain and bowel urgency were evaluated at baseline and Wk12 using items from the Inflammatory Bowel Disease Questionnaire, where pts rated trouble with abdominal pain, symptoms of bowel urgency, and the impact of bowel urgency over the past 2 wks using 7-point scales (1=all of the time to 7=none of the time). A ≥2 point increase from baseline was considered clinically meaningful improvement. All analyses were prespecified but not multiplicity controlled; all P values are nominal. Results: At baseline, percentages of pts with abdominal pain (GUS 77.7% and PBO 77.9%), symptoms of bowel urgency (GUS 86.0% and PBO 83.2%), and impact of bowel urgency (GUS 70.8% and PBO 70.4%) at least a little of the time (score ≤5) were similar between groups. GUS-treated pts showed greater improvements at Wk12 in these outcomes compared with PBO (Table 1). For abdominal pain, 52.0% of GUS-treated pts had clinically meaningful improvements from baseline at Wk12 vs 33.0% in the PBO group (P< 0.001), and 21.1% vs 12.3%, respectively, of those with abdominal pain at baseline had resolution at Wk12 (P=0.004; Figure 1A). For symptoms of bowel urgency, 58.6% vs 33.0%, respectively, had clinically meaningful improvements (P< 0.001; Figure 1B), and 24.0% vs 9.8%, respectively, of those with symptoms of bowel urgency at baseline had resolution at Wk12 (P< 0.001). Similarly, 57.7% vs 33.0%, respectively, had clinically meaningful improvements in the impact of bowel urgency (P< 0.001; Figure 1B), and 32.4% vs 13.1%, respectively, of those impacted at baseline had resolution at Wk12 (P< 0.001). Symptoms and impact of bowel urgency were combined into a bowel urgency score; of pts with symptoms or impact scores ≤6 at baseline, 19.7% vs 8.2%, respectively, had resolution of both at Wk12 (P< 0.001; Figure 1B). Conclusion: Pts receiving GUS showed clinically meaningful improvements in health-related quality of life measures related to abdominal pain and bowel urgency, including both the symptoms of bowel urgency and impact on pts’ lives.Figure 1.: Percentages of patients with clinically meaningful improvement (≥2 point change) from baseline to Wk12 among those with symptoms at baseline at least a little bit of the time (score ≤5) and resolution of symptoms at Wk12 among those with symptoms at baseline hardly any of the time (score ≤6) for symptoms of (A) abdominal pain and (B) bowel urgency. All P-values presented are nominal. Table 1. - Changes from baseline to Wk12 in abdominal pain, symptoms of bowel urgency, and impact of bowel urgency Outcome Change from baseline Placebo IV (N=261) Guselkumab 200 mg IV (N=405) P-value Abdominal pain Improved 123 (47.1%) 267 (65.9%) < 0.001 No change 102 (39.1%) 103 (25.4%) Worsened 36 (13.8%) 35 (8.6%) Symptoms of bowel urgency Improved 125 (47.9%) 288 (71.1%) < 0.001 No change 93 (35.6%) 89 (22.0%) Worsened 43 (16.5%) 28 (6.9%) Impact of bowel urgency Improved 110 (42.1%) 246 (60.7%) < 0.001 No change 101 (38.7%) 115 (28.4%) Worsened 50 (19.2%) 44 (10.9%) All P-values are nominal. P-values were based on the Cochran-Mantel-Haenszel (CMH) chi-square Row Mean Score test, stratified by ADT-failure status (Yes/No) and concomitant use of corticosteroids at baseline (Yes/No).
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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 | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
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 ».