S979 A Nationwide Comparison of Ozanimod and Upadacitinib Adverse Events in Ulcerative Colitis Patients: A Pharmacovigilance Investigation
Notice bibliographique
Résumé
Introduction: In the past decade, new biologics emerged for the treatment of ulcerative colitis (UC). Limited head-to-head trials of efficacy and safety profiles are available for these medications. Currently, the treatment of UC with biologics often stems from opinion-based algorithms, insurance coverage, and the clinical experience of gastroenterologists. In this study, we analyze a nationwide patient cohort in establishing a stratified safety profile with respect to ozanimod and upadacitinib. Methods: The US Food and Drug Administration’s Adverse Event Reports System (FAERS) data is a quarterly updated database which was queried primarily for ozanimod and upadacitinib in UC on February 5, 2023. The adverse events of infection and infestations, vascular, neuromusculoskeletal and skin with subcutaneous disorders were selectively considered to compare for the desired drugs. Analysis was performed using reported odds ratios (ROR) with 95% confidence interval (CI) and statistical significance P < 0.05. Results: A dataset of 768 adverse event cases were reported with ozanimod and upadacitinib in UC. 358 (46.6%) patients were male. There was no significant difference between rates of hospitalization between both drugs. Patients treated with ozanimod had significantly reduced risk of infectious complications compared to those patients being treated with upadacitinib [RR 0.52, 95% CI 0.38-0.73, P < 0.001] with common infections being nasopharyngitis, pneumonia, Clostridioides difficile gastroenteritis, urinary tract infection and sinusitis. However, patients treated with ozanimod had a significantly higher risk of vascular adverse events compared to those treated with upadacitinib [RR 5.38, 95% CI 2.00-14.50, P < 0.001] with hemorrhage being highest. Risk of neuromusculoskeletal complications is higher with ozanimod compared to those on upadacitinib [RR 1.43, 95% CI 1.07-1.92, P < 0.05] with most common events of headache, dizziness, back pain, and arthralgia. In addition, there was a significantly reduced risk of skin and subcutaneous tissue adverse reactions in patients on ozanimod compared to those on upadacitinib [RR 0.33, 95% CI 0.21-0.52, P < 0.001]. Incorporating gender and age did not yield any statistical significance. Conclusion: Compared to UC patients being treated with upadacitinib, UC patients being treated with ozanimod had a significantly increased risk of vascular and neuromusculoskeletal complications and a significantly reduced risk of infections and skin and subcutaneous adverse reactions (Figure 1).Figure 1.: Risk Ratio of Reported Events in Ozanimod vs Upadacitinib in Ulcerative Colitis.
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 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 | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| 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 découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, 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 ».