Discontinuation of infliximab treatment in patients with inflammatory bowel disease who retransitioned to originator and those who remained on biosimilar

Autor: Rosanne W. Meijboom, Helga Gardarsdottir, Matthijs L. Becker, Kris L. L. Movig, Johan Kuijvenhoven, Toine C. G. Egberts, Thijs J. Giezen

Publikováno v: Therapeutic Advances in Gastroenterology, Vol 16 (2023)

Background: Many patients with inflammatory bowel disease (IBD) have transitioned from an infliximab originator to a biosimilar. However, some patients retransition to the originator (i.e. stop biosimilar and reinitiate the originator). Whether this

Externí odkaz: https://doaj.org/article/77aacd70d06b45e8b69c4b191557d5ba

Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars

Autor: Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Hubert G. Leufkens, Helga Gardarsdottir

Publikováno v: Pharmaceuticals, Vol 14, Iss 3, p 189 (2021)

Regulatory approval of biosimilars predominantly relies on biosimilarity assessments of quality attributes (QAs), particularly the potentially critical QAs (pCQAs) that may affect the clinical profile. However, a limited understanding exists concerni

Externí odkaz: https://doaj.org/article/3a8bf199e05a43658c7c99fed2097b34

Drug-drug interactions with metronidazole and itraconazole in patients using acenocoumarol

Autor: Thijs J. Giezen, Karina Meijer, Renate C A E van Uden, Ilse Houtenbos, Patricia M. L. A. van den Bemt, Matthijs L. Becker

Publikováno v: European Journal of Clinical Pharmacology, 76(10), 1457-1464. Springer Verlag

PURPOSE: Various population-based cohort studies have shown that antimicrobial agents increase the risk of overanticoagulation in patients using coumarins. In this study, we assessed this association in hospitalized patients.METHODS: We included all

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f7a9338d75407334c7dcbe96285195c3
https://doi.org/10.1007/s00228-020-02930-z

Post‐marketing dosing changes in the label of biologicals

Autor: Aukje K. Mantel-Teeuwisse, Helga Gardarsdottir, Thijs J. Giezen, Lotte A. Minnema, Toine C. G. Egberts, Hubert G. M. Leufkens

Publikováno v: British Journal of Clinical Pharmacology
British Journal of Clinical Pharmacology, 85(4), 715. Wiley-Blackwell
British Journal of Clinical Pharmacology, 85(4), 715. NLM (Medline)

Aim: The aim of this study was to evaluate post-marketing label changes in dosing information of biologicals. Methods: Biologicals authorized between 2007 and 2014 by the European Medicines Agency (EMA) were included and followed up from marketing au

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e4749d01505b726ee524ff296cf37706
http://europepmc.org/articles/PMC6422665

Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions

Autor: Andrea Laslop, Thijs J Giezen, Martina Weise, Elena Wolff-Holz, Luis Pinheiro, Ana Hidalgo-Simon

Publikováno v: Clinical pharmacology & therapeutics, 110(5):1311-1317

The relevance of biological therapies for an increasing number of conditions is on the rise. Following the expiry of the initial period of market exclusivity, many of these successful therapies have seen the arrival of biosimilars on the market. The

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9c40ae4f613e17cc4d5c846c8c4bade6
https://pubmed.ncbi.nlm.nih.gov/34472087