Author:

Keywords:

Science & Technology, Life Sciences & Biomedicine, Medical Laboratory Technology, Pharmacology & Pharmacy, Toxicology, biosimilar, children, IBD, IFX, pharmacokinetics, COLITIS ACTIVITY INDEX, ULCERATIVE-COLITIS, CROHNS-DISEASE, DOUBLE-BLIND, INNOVATOR INFLIXIMAB, POSITION STATEMENT, PARALLEL-GROUP, CT-P13, THERAPY, EXPERIENCE, Adolescent, Antibodies, Monoclonal, Biosimilar Pharmaceuticals, C-Reactive Protein, Child, Colitis, Ulcerative, Crohn Disease, Drug Substitution, Female, Gastrointestinal Agents, Humans, Inflammatory Bowel Diseases, Infliximab, Male, Prospective Studies, Treatment Outcome, 0301 Analytical Chemistry, 1115 Pharmacology and Pharmaceutical Sciences, 3214 Pharmacology and pharmaceutical sciences

Abstract:

BACKGROUND: Rising evidence demonstrates that there are no differences in efficacy and safety between infliximab (IFX) originator and IFX biosimilar CT-P13 in the treatment of inflammatory bowel diseases (IBDs). However, most data are derived from adult patients, and data on pharmacokinetics are limited. The authors evaluated long-term IFX trough levels, immunogenicity, and remission rates in children with IBD who switched from IFX originator to biosimilar CT-P13. METHODS: In this single-center study, all children with Crohn disease and ulcerative colitis receiving maintenance IFX therapy were switched from originator to biosimilar CT-P13. Demographics, disease activity indices, and IFX drug levels were collected from 6 months before (baseline) till 6 months after switching to CT-P13. All data are presented as median (interquartile range). RESULTS: A total of 42 children (26 Crohn disease and 16 ulcerative colitis), with a median duration on IFX originator of 13.5 (6.8-35.5) months before switching to CT-P13, were included. No significant changes in IFX trough levels occurred after switching. The median baseline IFX trough level was 5.7 mcg/mL (3.8-9.3) versus 6.5 mcg/mL (3.9-8.6) at month 6 after switching (P = 0.900). Antibodies to IFX appeared in one patient after switching. The proportion of patients in clinical and/or biological remission did not significantly change after switching (all P > 0.05). No significant changes were observed in C-reactive protein, erythrocyte sedimentation rate, albumin, weight, and body mass index after the switch. Safety profile was also comparable. CONCLUSIONS: Pediatric patients with IBD on IFX originator can be successfully switched during maintenance to biosimilar CT-P13 without affecting efficacy, pharmacokinetics, immunogenicity, or safety.