RT Journal Article
T1 Effectiveness and Safety of CT-P13 (Biosimilar Infliximab) in Patients with Inflammatory Bowel Disease in Real Life at 6 Months.
A1 Argüelles-Arias, F
A1 Guerra Veloz, M F
A1 Perea Amarillo, R
A1 Vilches-Arenas, A
A1 Castro Laria, L
A1 Maldonado Pérez, B
A1 Chaaro, D
A1 Benítez Roldán, A
A1 Merino, V
A1 Ramírez, G
A1 Caunedo Álvarez, A
A1 Romero Gómez, M
K1 Biosimilar agent
K1 CT-P13
K1 Crohn’s disease
K1 Infliximab
K1 Ulcerative colitis
AB 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.
YR 2017
FD 2017-03-09
LK http://hdl.handle.net/10668/10954
UL http://hdl.handle.net/10668/10954
LA en
DS RISalud
RD Apr 17, 2025