Argüelles-Arias, FedericoGuerra Veloz, Maria FernandaPerea Amarillo, RaulVilches-Arenas, AngelCastro Laria, LuisaMaldonado Pérez, BelenChaaro Benallal, DinaBenítez Roldán, AntonioMerino, VicenteRamirez, GabrielCalleja-Hernández, Miguel AngelCaunedo Álvarez, AngelRomero Gómez, Manuel2023-01-252023-01-252017http://hdl.handle.net/10668/11576Biological 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. 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. 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. Switching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/AdultAntibodies, MonoclonalBiosimilar PharmaceuticalsC-Reactive ProteinColitis, UlcerativeCrohn DiseaseDrug SubstitutionFemaleFollow-Up StudiesGastrointestinal AgentsHumansInfliximabMaleMiddle AgedProspective StudiesSeverity of Illness IndexTime Factorsresearch article28902041open access10.1097/MEG.00000000000009531473-5687PMC5640013https://europepmc.org/articles/pmc5640013?pdf=renderhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5640013/pdf