Adalimumab Long-term Effectiveness in Adalimumab-Naive Patients With Crohnʼs Disease: Final Data From PYRAMID Registry
Notice bibliographique
Résumé
Introduction: PYRAMID was an international multi-center non-interventional postmarketing registry assessing long-term safety and effectiveness of adalimumab (ADA) as used in routine clinical practice. Patients (Pts) with and without prior ADA experience were allowed to enroll. The final long-term effectiveness of ADA is reported in adult ADA-naïve pts (those who had not received ADA before registry enrollment) with moderate to severe Crohn's disease (CD) who were treated according to the local product label. Methods: All pts entering the registry were followed for up to 6 years. Effectiveness of ADA was measured using Physician's Global Assessment (PGA; [a composite of Harvey Bradshaw Index and rectal bleeding score]), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and 4 components of the Work Productivity and Activity Impairment (WPAI) questionnaire, including absenteeism, presenteeism, overall work impairment, and activity impairment. Effectiveness measures, captured in all pts who received at least 1 dose of ADA in the registry and had at least 1 post-enrollment measurement, were summarized descriptively by the number of observations that were not missing at each registry visit; data were reported as observed. Values at enrollment are considered as baseline values. Results: Among 5025 pts evaluated in the registry, 2057 (40.9%) were ADA-naïve. Of these, 1199 pts (58.3%) were female; mean age 37.1 years at enrollment. Mean±SD ADA exposure for the ADA-naïve subgroup during the registry was 1118.5±842.3 days. A total of 1082 pts (52.6%) had prior exposure to at least 1 anti-TNF/biologic; 853 (41.5%) and 831 pts (40.4%) used immunomodulators and corticosteroids, respectively, at enrollment. Mean change from baseline in effectiveness measures for pts with CD is shown in the table. Mean PGA score and SIBDQ as well as WPAI domains improved in ADA-naïve pts from enrollment to 1 year and were sustained for up to 6 years (table). No new safety signals were identified in the registry. Conclusion: At 1 year after entering the international postmarketing registry of ADA use in routine clinical practice, clinically meaningful improvements in disease activity, work productivity, and activity impairment were achieved in ADA-naïve pts with moderately to severely active CD. These improvements were maintained for up to 6 years of the registry among the pts who remained in the study.Table: Table. Change from enrollment (baseline) in effectiveness measure scores in ADA-naïve pts with CD ( N =2057)
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 | 0,005 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,002 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 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 ».