| Literature DB >> 27435444 |
Kornelius Schulze1, Nadine Koppka2, Frederik Lutter3, Gunnar Brandhorst4, Stefan Schreiber3, Ulf Helwig5.
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™.Entities:
Keywords: CT-P13; Inflammatory bowel disease (IBD); Inflectra™; Infliximab biosimilar; Remicade™; Remsima™
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Year: 2016 PMID： 27435444 DOI： 10.1016/j.biologicals.2016.06.011
Source DB: PubMed Journal: Biologicals ISSN： 1045-1056 Impact factor: 1.856