Implementation of CT-P13 via a Managed Switch Programme in Crohn’s Disease: 12-Month Real-World Outcomes

• Published in: Digestive diseases and sciences 2019-06, Vol.64 (6), p.1660-1667
• Main Authors: Plevris, Nikolas, Jones, Gareth R., Jenkinson, Philip W., Lyons, Mathew, Chuah, Cher S., Merchant, Lynne M., Pattenden, Rebecca J., Watson, Eleanor F., Ho, Gwo-Tzer, Noble, Colin L., Din, Shahida, Shand, Alan G., Arnott, Ian D., Lees, Charlie W.
• Format: Article
• Language: English
• Subjects: Adult; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Anti-Inflammatory Agents - pharmacokinetics; Antibodies; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - pharmacokinetics; Biochemistry; Biological products; Biological Products - administration & dosage; Biological Products - adverse effects; Biological Products - pharmacokinetics; Biomarkers; Biosimilar Pharmaceuticals - administration & dosage; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - pharmacokinetics; Clinical outcomes; Cost control; Crohn Disease - diagnosis; Crohn Disease - drug therapy; Crohn Disease - immunology; Crohn's disease; Drug Administration Schedule; Drug Substitution; Enzymes; Female; Gastroenterology; Hepatology; Hospitals; Humans; Immunotherapy; Inflammatory bowel disease; Infliximab - administration & dosage; Infliximab - adverse effects; Infliximab - pharmacokinetics; Laboratories; Male; Medicine; Medicine & Public Health; Middle Aged; Monoclonal antibodies; Oncology; Original Article; Program Evaluation; Prospective Studies; Remission (Medicine); Time Factors; TNF inhibitors; Transplant Surgery; Treatment Outcome; Tumor necrosis factor-TNF; Viral antibodies
• ISSN: 0163-2116; 1573-2568
• DOI: 10.1007/s10620-018-5406-8

Background Switching from Remicade to CT-P13 allows for significant cost savings and has been shown to be non-inferior to continued therapy with Remicade for the treatment of Crohn’s disease. Aim The aim of this work was to prospectively evaluate clinical outcomes in a cohort of patients with Crohn’s disease switching from Remicade to CT-P13. Methods A prospective service evaluation was performed. The Harvey-Bradshaw index, CRP, faecal calprotectin and serum for infliximab/antibody levels were collected prior to patients' final Remicade infusion and at 6 and 12 months after switching to CT-P13 as part of routine clinical care. All adverse events during follow-up were also recorded. Results One hundred and ten patients on Remicade switched to CT-P13. No significant difference was observed between the Harvey-Bradshaw Index ( p  = 0.07), CRP ( p  = 0.13), faecal calprotectin ( p  = 0.25) or trough infliximab levels ( p  = 0.47) comparing before and at 6 and 12 months after the switch to CT-P13. Seven patients developed new infliximab antibodies after switching from Remicade to CT-P13. The majority of patients remained on CT-P13 at 12 months (84.5%) and the rate of adverse events and serious adverse events was 53.8 and 13.5 per 100 patient-years of follow-up, respectively. Switching to CT-P13 resulted in a cost saving of approximately 46.4%. Conclusion The transition to CT-P13 from Remicade for the treatment of Crohn’s disease is safe and has no negative effect on clinical outcomes at 12 months.