Safety and efficacy of switching from infliximab biosimilar CT-P13 to infliximab biosimilar SB2 in patients with inflammatory bowel disease.
Journal
European journal of gastroenterology & hepatology
ISSN: 1473-5687
Titre abrégé: Eur J Gastroenterol Hepatol
Pays: England
ID NLM: 9000874
Informations de publication
Date de publication:
01 02 2021
01 02 2021
Historique:
entrez:
28
12
2020
pubmed:
29
12
2020
medline:
3
8
2021
Statut:
ppublish
Résumé
For patients with inflammatory bowel diseases, switching from infliximab originator to biosimilars is effective and safe. Few data on single switch have been published, and data on multiple switches of different infliximab are unavailable. A retrospective analysis of patients who switched from CT-P13 to SB2, and of those with multiple switches among different infliximab compounds was conducted. Clinical activity, C reactive protein (CRP), adverse events (AE) and loss of response (LOR) were recorded. Thirty-six patients (26 males, 14 Crohn's disease and 22 ulcerative colitis) were enrolled and followed up for >6 months. All patients switched from CT-P13 to SB2; 12 of them (33.3%) had already switched from reference Infliximab to CT-P13, and for the remaining patients CT-P13 was the first infliximab. The clinical remission rate six months before and three months after SB2-switch was the same (58.3%) and the rate of mild activity varied from 27.8 to 33.3% (P = 0.68); the percentage of patients with normal CRP values passed from 94.4 to 91.7% (P = 1). Two patients (5.5%) had AE and 11 (30.5%) a LOR. At univariate analysis, patients with a single switch had a non-significant risk of LOR during SB2 [odds ratio (OR) = 7.86; 95% confidence interval (CI) 0.87-71, P = 0.06]. SB2-LOR was associated with previous AE under CT-P13 (OR = 9.1, 95% CI 0.82-100, P = 0.07). None of such factors was significant at multivariate analysis. Switching from CT-P13 to SB2 seems to be safe and effective either in patients with a single than in those with multiple switches.
Identifiants
pubmed: 33369956
doi: 10.1097/MEG.0000000000001988
pii: 00042737-202102000-00011
doi:
Substances chimiques
Antibodies, Monoclonal
0
Biosimilar Pharmaceuticals
0
CT-P13
0
Gastrointestinal Agents
0
Infliximab
B72HH48FLU
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
201-207Informations de copyright
Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.
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