A149 REAL WORLD OUTCOMES OF NON-MEDICAL SWITCHING OF INFLIXIMAB BIOSIMILAR IN BRITISH COLUMBIA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD)
Notice bibliographique
Résumé
Abstract Background A mandated non-medical switch to the infliximab biosimilars was launched in British Columbia in 2019. British Columbia was the first province in Canada to mandate the switch from the originator infliximab (RemicadeTM) to one of the 2 approved biosimilars (InflectraTM or RenflexisTM). There is limited data for mandatory non-medical switching in IBD as was undertaken in BC. Aims This study aimed to obtain real-world evidence evaluating the clinical outcomes of nonmedical switch from Remicade to the infliximab biosimilars. Methods This is a retrospective observational study from the IBD Centre of BC (a tertiary care referral centre in Vancouver, BC). Patients on infliximab at the time of the mandated switch were identified through search of the electronic medical record. The primary outcome was drug continuation at 12 months post switch. Secondary outcomes included flare of disease, adverse events, and number of doctor visits within the first 12 months post switch. A comparison group included patients maintained on originator infliximab. Results A total of 235 patients were evaluated; 175 patients in the biosimilar switch group, and 60 patients in the control group. Baseline characteristics of the groups were similar. Discontinuation of infliximab occurred in 22 patients (17 in biosimilar switch group and 5 in the control group. There was no difference in the rate of discontinuation of infliximab between the biosimilar group (9.7%) and the originator molecule group (8.3%); chi squared (1, N=235) = 0.1004, p = .75. The most common reason for discontinuation was flare of disease in 6 patients in the biosimilar group and 4 patients in the control group. An additional 4 patients in the biosimilar group and 3 patients in the control group had a flare of symptoms but were maintained on therapy with an escalation of dosage or course of corticosteroids. Two patients had active disease at the time of switch and discontinued therapy. Adverse events accounted for discontinuation in 5 patients on biosimilar and 1 in the control group. These included joint pain, epigastric symptoms, drug intolerance, drug induced lupus, and drug induced pulmonary nodules in the biosimilar group, and drug induced vasculitis in the control group. Two patients in the biosimilar group discontinued due to antibody formation. Two patients in the biosimilar group discontinued therapy due to preference. Conclusions In this small subset of the BC IBD population undergoing a non-medical biosimilar switch of infliximab, there was no difference in the discontinuation rate between the biosimilars or the originator infliximab molecule. These findings are consistent with the existing real-world evidence. Funding Agencies None
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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 | 0,002 | 0,001 |
| 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 | 0,000 |
| 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 ».