TY - JOUR
T1 - Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases
T2 - A prospective, multicentre, nationwide cohort
AU - Gecse, Krisztina B.
AU - Lovász, Barbara D.
AU - Farkas, Klaudia
AU - Banai, János
AU - Bene, László
AU - Gasztonyi, Beáta
AU - Golovics, Petra Anna
AU - Kristóf, Tünde
AU - Lakatos, László
AU - Csontos, Ágnes Anna
AU - Juhász, Márk
AU - Nagy, Ferenc
AU - Palatka, Károly
AU - Papp, Mária
AU - Patai, Árpád
AU - Lakner, Lilla
AU - Salamon, Ágnes
AU - Szamosi, Tamás
AU - Szepes, Zoltán
AU - Tóth, Gábor T.
AU - Vincze, Áron
AU - Szalay, Balázs
AU - Molnár, Tamás
AU - Lakatos, Péter L.
N1 - Funding Information: The performance of therapeutic drug level monitoring was supported by an unrestricted research grant by Hospira. Publisher Copyright: © 2016 Oxford University Press. All rights reserved. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2020
Y1 - 2020
N2 - Background and Aims: Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. Methods: A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. Results: In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. Conclusions: This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions.
AB - Background and Aims: Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. Methods: A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. Results: In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. Conclusions: This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions.
KW - Biosimilar
KW - CT-P13
KW - Crohn's disease
KW - Efficacy
KW - Immunogenicity
KW - Inflammatory bowel diseases
KW - Infliximab
KW - Safety
KW - Ulcerative colitis
UR - http://www.scopus.com/inward/record.url?scp=85020318416&partnerID=8YFLogxK
U2 - https://doi.org/10.1093/ecco-jcc/jjv220
DO - https://doi.org/10.1093/ecco-jcc/jjv220
M3 - Article
C2 - 26661272
SN - 1873-9946
VL - 10
SP - 133
EP - 140
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 2
ER -