P329 Effect of adalimumab dose escalation on clinical, health-related quality of life, treatment satisfaction and work productivity outcomes among patients with ulcerative colitis in a clinical practice setting: results from INSPIRADA
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Résumé
Background: Although adalimumab (ADA) has been shown to induce and maintain clinical remission in moderate to severe ulcerative colitis (UC), some patients (pts) may lose initial response and could benefit from dose escalation [1]. We assessed the effect of ADA dose escalation on various outcomes among pts with UC in clinical practice. Methods: INSPIRADA was a single-arm, multi-country, open-label study that evaluated the effect of ADA on clinical outcomes, costs of care, treatment satisfaction, and work productivity in pts with UC treated according to usual clinical practice. Adults with active UC, Physician's Global Assessment (PGA) of ≥2, and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ≤45 at baseline (BL) who failed conventional treatment and who had experienced rectal bleeding ≤7 days of BL were enrolled. Pts received ADA 160/80 mg at Wk 0/2 followed by ADA 40 mg every other week at Wk 4 through Wk 26. Pts who did not respond to ADA by Wk 8 were to discontinue ADA. Pts who lost response at or after Wk 8 could escalate to ADA 40 mg weekly. Outcomes were assessed for pts who dose escalated. Clinical outcomes included Simple Clinical Colitis Activity Index (SCCAI) response (SCCAI decrease ≥2) and remission (defined as an SCCAI ≤2). HRQoL was assessed using SIBDQ and the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) questionnaire. Satisfaction with medication was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). Work Productivity and Activity Impairment (WPAI) outcomes were determined. Change from BL to Wk 26 in HRQoL, treatment satisfaction, and WPAI outcomes were calculated. Missing data were imputed using nonresponder imputation for response/remission and last observation carried forward for all other outcomes. Results: Data from 129 pts who dose escalated were analysed. At Wk 26, 64% of pts who dose escalated achieved SCCAI response and 33% achieved SCCAI remission (Table 1). Except for work time missed and convenience in TSQM among pts who dose escalated, statistically significant (p<0.001) improvements from BL to Wk 26 were seen in work productivity, performance of daily activities, SIBDQ, EQ-5D-5L, and treatment satisfaction. The safety profile of ADA among pts who dose escalated was consistent with that of pts who did not dose escalate. Conclusions: In pts with UC who lost response, ADA dose escalation was an effective option to recapture response and remission. Significant improvements in HRQoL, treatment satisfaction, and work productivity were also observed. References: [1] Wolf et al, (2014), APT, 40:486–97
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,009 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| 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 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 découle