Anti-Drug Antibodies in Patients with Inflammatory Bowel Diseases Treated with Biosimilar Infliximab: A Prospective Cohort Study

Journal of Clinical Medicine

Anna Pękala¹  Rafał Filip¹  David Aebisher² 

[1] Department of Gastroenterology, IBD Unit of Clinical Hospital 2, Lwowska 60 Str., 35-301 Rzeszow, Poland;Department of Photomedicine and Physical Chemistry, Faculty of Medicine, University of Rzeszow, Warzywna 1A Str., 35-310 Rzeszow, Poland;

关键词: inflammatory bowel disease;    biosimilar infliximab;    immunogenicity;    ADA;    CT-P13;    anti-TNF;   

DOI  :  10.3390/jcm10122653

来源: DOAJ

【 摘 要 】

Reports of the prevalence of antibodies to infliximab (anti-drug antibodies, ADA) are inconsistent due in part to the various assay formats used to monitor immunogenicity in the clinic and under clinical trial settings. This study aimed to determine the frequency of ADA in patients with inflammatory bowel disease (IBD) during induction and maintenance therapy with biosimilar infliximab (CT-P13) using the ELISA (enzyme-linked immunosorbent assay) method. In this prospective single-center study, we analyzed the incidence of ADA and the relationship between the presence of ADA and the following variables: gender, type of disease, immunosuppressive therapy used, and duration of treatment. A total of 84 patients with IBD received CT-P13 and were followed up for an average of 7 months. We found ADA in 50% of the patients with undetectable levels of the drug. The percentage of persons with antibodies detected during induction treatment was 11.3% compared to 9.6% during maintenance therapy. The analysis showed no relationship between response to treatment and antibody titers (p = 0.381). The study showed a statistically significant relationship between undetectable levels of CT-P13 and the presence of ADA at week 6 of therapy (i.e., ADA were detected in all the patients with undetectable levels of CT-P13). Patients with IBD and undetectable levels of CT-P13 before administration of the third induction dose were at high risk of the presence of anti-drug antibodies as well as primary non-response.

【 授权许可】

Unknown