P417 Frequent Early Nocebo Complaints but Maintained Clinical Efficacy, Biomarker and Therapeutic drug levels following mandatory Biosimilar Switch in Patients with Inflammatory Bowel disease: Preliminary data from a Prospective Observational Cohort Study
Notice bibliographique
Résumé
Abstract Background Current evidence suggests that biosimilar is safe and effective for patients with IBD. There is limited data on and nocebo effect after switching from originator to biosimilar. We aimed to report clinical efficacy, therapeutic drug monitoring, adverse events (AEs), and frequency of nocebo in IBD patients with biosimilar switches. Methods We performed a prospective observational study of 257 consecutive IBD patients who underwent biosimilar switch at McGill University Health Centre, Montreal, Canada, between November 2021 and October 2022. We excluded 74 patients due to missing follow-up data/delay in the switch. Patients underwent a mandatory switch from the originator (Remicade or Humira) to biosimilars due to a change of the reimbursement policy in Quebec. Clinical and biochemical data were captured at 8 weeks before switch, baseline (time of the switch), and 12 and 24 weeks after the switch. Clinical remission was defined as an HBI<5 for Crohn’s disease (CD) or a partial Mayo<3 points for ulcerative colitis (UC). Biomarkers remission was defined as C-reactive protein (CRP<5mg/mL) and fecal calprotectin (FCAL)<250 mcg/g. Drug trough levels and anti-drug antibodies were measured at baseline and week 24 (therapeutic level was defined as infliximab level≥3mcg/mL, adalimumab≥5mcg/mL). AEs and nocebo effects were assessed. Results A total of 183 patients were included [79.2% were CD, male 57.4%, median age at inclusion 46 years (IQR 30-52), and median duration of disease 13 years (IQR8-22)]. There was no significant difference in the proportion of patients in clinical remission at week 8 before the switch(88.5%), baseline(93.8%), week 12(85.7%) and week 24(88.7%), p=0.835. Similarly, the proportion of patients remaining in biomarkers remission was not significantly different at week 8 before the switch, baseline, week 12 and week 24; CRP (82.4%/75.0%/80.0%/77.3%), p=0.760; FCAL (76.7%/77.8%/71.2/77.3%), p=0.932, as well as there was no significant difference in the proportion of patients maintaining the therapeutic level, (85.5%/82.2%/79.6%, p=0.853) and prevalence of positive anti-drug antibody at (10.5%/4.4%/11.8%, p=0.190) at 8 weeks before switch, baseline, and week 24, respectively. 14.5% of patients had subtherapeutic drug levels, 6% underwent dose optimization, and 4.4% had a loss of response/relapse. Nocebo was reported in 12% of patients (9.3% within the first 12 weeks and 2.7% within the first 24 weeks after the switch), 5.5% had drug AEs,and 3.8% discontinued biosimilars due to AEs. Conclusion Despite a significant number of early nocebo complaints within the first 3 months after the biosimilar switch, no significant changes were found in clinical efficacy, therapeutic drug trough level, and anti-drug antibodies.
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 | 0,002 | 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 | 0,000 |
| 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 ».