1. Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results
- Author
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Federico Argüelles-Arias, Raúl Perea Amarillo, Ángel Vilches-Arenas, Manuel Romero Gómez, Ángel Caunedo Álvarez, Dina Chaaro Benallal, María Fernanda Guerra Veloz, Belén Maldonado Pérez, V Merino, Luisa Castro Laria, Gabriel Ramirez, Antonio Benítez Roldán, and Miguel Angel Calleja-Hernández
- Subjects
Crohn’s disease ,Adult ,Male ,medicine.medical_specialty ,Time Factors ,Inflammatory bowel disease ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,Biosimilar Pharmaceuticals ,Crohn Disease ,Gastrointestinal Agents ,inflammatory bowel disease ,Internal medicine ,Severity of illness ,medicine ,Humans ,Prospective Studies ,ulcerative colitis ,Gastrointestinal agent ,Crohn's disease ,Hepatology ,business.industry ,Drug Substitution ,Gastroenterology ,Antibodies, Monoclonal ,Biosimilar ,Middle Aged ,medicine.disease ,Ulcerative colitis ,Infliximab ,Original Articles: Inflammatory Bowel Disease ,C-Reactive Protein ,030220 oncology & carcinogenesis ,biosimilar agent ,030211 gastroenterology & hepatology ,Colitis, Ulcerative ,Female ,business ,CT-P13 ,medicine.drug ,Follow-Up Studies - Abstract
Background Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. Materials and methods This was a prospective single-center observational study in patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade) to CT-P13 treatment and followed up for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals, according to the Harvey–Bradshaw score and partial Mayo score for patients with CD and UC, respectively. C-reactive protein (CRP) was also measured. Adverse events were monitored and recorded throughout the study. Results A total of 98 patients with inflammatory bowel disease (67 CD/31 UC) were included. A total of 83.6% (56/67) of patients with CD were in remission at the time of the switch and 62.7% were in remission at 12 months. The Harvey–Bradshaw score showed a significant change at 12 months (P=0.007) but no significant change was observed in median CRP at this timepoint (P=0.364). A total of 80.6% (25/31) of patients with UC were in remission at the time of the switch and 65.3% (18/28) were in remission at 12 months. No significant changes in the median partial Mayo score (P=0.058) or CRP (P=0.329) were observed at 12 months. Serious adverse events related to medication were reported in 11 (11.2%) patients. Conclusion Switching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months.
- Published
- 2017