P519 Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: Multicentre study at 12 months results
Notice bibliographique
Résumé
Infliximab have changed the natural history of inflammatory bowel diseases (IBD). However, with the advent of biosimilar treatment such as CT-P13 promises to improve availability of biological therapy. Nowadays switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with IBD. This was a multicentre prospective observational study conducted at the Virgen Macarena Hospital and Juan Ramon Jiménez Hospital (Seville- Huelva, Spain) from March 2015 to February 2016 in patients with Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade®) to CT-P13 treatment and followed for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score, and C-reactive protein (CRP) for patients with CD and UC, respectively. A total of 167 patients with IBD (116 with CD and 51 with UC) were included. The Baseline demographics according to the Montreal Classification are shown in Figure. Basal remission 87.4% (146 of 167), 12 months post switch 71.7% (109 of 152). Loss of efficacy at 12 months was 15.7%. 9% of patients discontinued CT-P13 during follow-up. CD patient group 88.8% (103 of 116) of patients with CD were in remission at the time of the switch and 69.7% were in remission at 12 months (P > 0.05. In total, 94.0% (109 of 116) of patients with CD completed 12 months of follow-up. The HB score showed significant changes over the 12-month period (median HB score: 1 [0–1] vs. 1 [0–2] (p = 0.001. No significant changes in median CRP levels were observed at 12 months (p = 0.49). UC patient group 84.3% (43 of 51) of patients with UC were in remission at the time of the switch and 76.7% were in remission at 12 months (p > 0.05). In total, 84.3% (43 of 51) of patients with UC completed 12 months of follow-up. No significant changes in the median partial Mayo score (p = 0.87) were observed at 12 months. Significant changes in the median CRP level were observed over the same period (0.8 [0–4] vs. 0.23 [0–0.58]) (p = 0.003). Serious adverse events related to medication were reported in 12 of 167 (7.2%). Abstract P519 – Baseline characteristics study patients. Switching from infliximab RP to CT-P13 is safe and efficacious at 12 months. Loss of efficacy at 12 months was 15.7%. Global remission in patients with IBD.
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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 | 0,000 | 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) | 0,000 | 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 ».