DI-077 Effectiveness and safety of biosimilar infliximab in ulcerative colitis
Notice bibliographique
Résumé
<h3>Background</h3> Infliximab is one of the most widely used alternatives in ulcerative colitis (UC). The recent appearance of a biosimilar makes it necessary to assess its use. <h3>Purpose</h3> To assess the effectiveness and safety of biosimilar infliximab in patients with UC. <h3>Material and methods</h3> Retrospective observational study performed in a tertiary hospital. Patients included were those with UC who were being treated with Remicade and then switched to Remsima (biosimilar infliximab) from March to June 2015. Effectiveness and safety were assessed 3 months after the switch. The following variables were collected: age, sex, concomitant therapy, disease classification according to the Montreal Scale (severity and extention) in UC, effectiveness and adverse effects. Effectiveness was measured using the True-Love-Witts Scale and C reactive protein (CRP) levels before and 3 months after the switch. Safety was assessed by collecting all adverse events that occurred during treatment. <h3>Results</h3> 25 patients were included, 52% were women with an average age of 45 years (21–71). At inclusion, 20% of patients were treated concomitantly with corticosteroids and 36% with azathioprine/mercaptopurine. According to the Montreal Scale, 28% of patients had an extension level of E2, 72% had E3 and none had E1. On the other hand, the severity variable was distributed as follows: 8% of patients S0, 32% S1, 48% S2 and 12% S3. At baseline, 23 patients had stabilised disease and 2 had minor outbreaks. Effectiveness was assessed in 12 patients who were reviewed 3 months after the switch. One patient had a minor outbreak at the beginning and no clinical change occurred after the use of the biosimilar. As for the remaining evaluated patients, 8 maintained the same Tru-Love-Witts score and 4 had a decrease. There was no clinically relevant increase in CRP. No adverse events were detected after the switch. <h3>Conclusion</h3> Despite being a preliminary assessment with just a few patients, initial data showed that the switch to an infliximab biosimilar did not represent a decrease in effectivenees and/or safety in patient with UC. Long term assessment of these patients is required to confirm these results. No conflict of interest.
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) | 0,000 | 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) | 0,001 | 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 ».