کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5517030 | 1400866 | 2016 | 4 صفحه PDF | دانلود رایگان |
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 Remicadeâ¢-validated ELISA to determine drug serum levels of Remsima⢠or Inflectraâ¢. 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 Remicadeâ¢. Additionally, anti-drug antibody levels were not significantly different in patients treated with Remsima⢠or Inflectra⢠compared to patients treated with Remicadeâ¢. 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 Inflectraâ¢.
Journal: Biologicals - Volume 44, Issue 5, September 2016, Pages 463-466