title: CT-P13 (Inflectra™, Remsima™) monitoring in patients with inflammatory bowel disease.
abstract: The approval of infliximab biosimilars Remsima™ and Inflectra™ (CT-P13) for patients with inflammatory bowel disease (IBD) is a promising step to reduce treatment costs. Since monitoring of Remicade™ serum trough levels and anti-Remicade™ immunogenicity hold an important significance in treatment modalities, no data about monitoring of drug serum trough levels or anti-drug antibody levels in IBD patients treated with Remsima™ or Inflectra™ are present to date. Therefore, in this study we applied a Remicade™-validated ELISA to determine drug serum levels of Remsima™ or Inflectra™. Serum concentrations were measured at identical levels compared to Remicade™ at multiple time points over 38 weeks, suggesting that the monitoring of serum trough levels is equally feasible for patients receiving Remsima™ or Inflectra™ and Remicade™. Additionally, anti-drug antibody levels were not significantly different in patients treated with Remsima™ or Inflectra™ compared to patients treated with Remicade™. To our knowledge this is the first real-life experience demonstrating the feasibility of drug monitoring in IBD patients treated with the infliximab biosimilars Remsima™ and Inflectra™.
authors.affiliation: I. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Kornelius
authors.initials: K
authors.lastname: Schulze
authors.affiliation: Medical Practice for Internal Medicine Oldenburg, Neue Donnerschweer Str. 30, 26123 Oldenburg, Germany.
authors.forename: Nadine
authors.initials: N
authors.lastname: Koppka
authors.affiliation: University Hospital Schleswig Holstein Campus Kiel, Christian Albrechts-University Kiel, Germany.
authors.forename: Frederik
authors.initials: F
authors.lastname: Lutter
authors.affiliation: Medlab Oldenburg, Koppelstr. 7, 26135 Oldenburg, Germany.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Brandhorst
authors.affiliation: University Hospital Schleswig Holstein Campus Kiel, Christian Albrechts-University Kiel, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
authors.affiliation: Medical Practice for Internal Medicine Oldenburg, Christian-Albrechts University Kiel, Neue Donnerschweer Str. 30, 26123 Oldenburg, Germany. Electronic address: helwig@internisten-ol.de.
authors.forename: Ulf
authors.initials: U
authors.lastname: Helwig
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000493:pharmacokinetics; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000493:pharmacokinetics; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000097:blood* / Q000188:drug therapy*; D000069285:Infliximab; D008297:Male; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab
keywords: CT-P13; Inflammatory bowel disease (IBD); Inflectra™; Infliximab biosimilar; Remicade™; Remsima™