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Title: Effectiveness and Safety of CT-P13 (Biosimilar Infliximab) in Patients with Inflammatory Bowel Disease in Real Life at 6 Months.
Authors: Argüelles-Arias, F
Guerra Veloz, M F
Perea Amarillo, R
Vilches-Arenas, A
Castro Laria, L
Maldonado Pérez, B
Chaaro, D
Benítez Roldán, A
Merino, V
Ramírez, G
Caunedo Álvarez, A
Romero Gómez, M
Keywords: Biosimilar agent;CT-P13;Crohn’s disease;Infliximab;Ulcerative colitis
metadata.dc.subject.mesh: Adult
Antibodies, Monoclonal
Drug Administration Schedule
Inflammatory Bowel Diseases
Middle Aged
Prospective Studies
Remission Induction
Issue Date: 9-Mar-2017
Abstract: CT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy. 87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study. CT-P13 was efficacious and well tolerated in patients with CD or UC.
metadata.dc.identifier.doi: 10.1007/s10620-017-4511-4
Appears in Collections:Producción 2020

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