Cargando…

Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study

Background: Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, is characterized by chronic relapsing intestinal inflammation. There are few data on the efficacy and safety in clinical practice of infliximab (CT-P13) in subcutaneous formulation (SC) for the treatment...

Descripción completa

Detalles Bibliográficos
Autores principales: Huguet, Jose M., García-Lorenzo, Victor, Martí, Lidia, Paredes, Jose María, Ramírez, Jose Joaquin, Pastor, Miguel, Ruiz, Lucia, Sanahuja, Ana, Timoneda, Pilar, Sanchís, Laura, Pérez, Gloria Alemany, Boscá-Watts, Marta Maia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9495964/
https://www.ncbi.nlm.nih.gov/pubmed/36140230
http://dx.doi.org/10.3390/biomedicines10092130
_version_ 1784794151935541248
author Huguet, Jose M.
García-Lorenzo, Victor
Martí, Lidia
Paredes, Jose María
Ramírez, Jose Joaquin
Pastor, Miguel
Ruiz, Lucia
Sanahuja, Ana
Timoneda, Pilar
Sanchís, Laura
Pérez, Gloria Alemany
Boscá-Watts, Marta Maia
author_facet Huguet, Jose M.
García-Lorenzo, Victor
Martí, Lidia
Paredes, Jose María
Ramírez, Jose Joaquin
Pastor, Miguel
Ruiz, Lucia
Sanahuja, Ana
Timoneda, Pilar
Sanchís, Laura
Pérez, Gloria Alemany
Boscá-Watts, Marta Maia
author_sort Huguet, Jose M.
collection PubMed
description Background: Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, is characterized by chronic relapsing intestinal inflammation. There are few data on the efficacy and safety in clinical practice of infliximab (CT-P13) in subcutaneous formulation (SC) for the treatment of patients with IBD. Methods: Multicenter, prospective study of patients with IBD in clinical remission, who had their treatment changed from intravenous (IV) infliximab to SC. Two groups of patients were evaluated according to whether they were on IV infliximab treatment at standard or intensified doses before the switch. Results: A total of 30 patients were on standard dosing and another 30 in intensified therapy. Treatment persistence in both groups at 6 months was greater than 95%. In both groups after the change, neither the biomarkers of inflammation nor the activity indices underwent significant changes at 3 and 6 months compared to the baseline value. Similarly, in both groups, infliximab trough levels showed a significant increase 3 and 6 months after the change to SC. No serious adverse events were registered. Conclusions: The CT-P13 SC brings a new anti-TNF era. Achieving much higher drug levels that are constant over time opens new paths to explore the management of patients with IBD: less immunogenicity, better perianal disease control and higher achievement of mucosal healing.
format Online
Article
Text
id pubmed-9495964
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-94959642022-09-23 Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study Huguet, Jose M. García-Lorenzo, Victor Martí, Lidia Paredes, Jose María Ramírez, Jose Joaquin Pastor, Miguel Ruiz, Lucia Sanahuja, Ana Timoneda, Pilar Sanchís, Laura Pérez, Gloria Alemany Boscá-Watts, Marta Maia Biomedicines Article Background: Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, is characterized by chronic relapsing intestinal inflammation. There are few data on the efficacy and safety in clinical practice of infliximab (CT-P13) in subcutaneous formulation (SC) for the treatment of patients with IBD. Methods: Multicenter, prospective study of patients with IBD in clinical remission, who had their treatment changed from intravenous (IV) infliximab to SC. Two groups of patients were evaluated according to whether they were on IV infliximab treatment at standard or intensified doses before the switch. Results: A total of 30 patients were on standard dosing and another 30 in intensified therapy. Treatment persistence in both groups at 6 months was greater than 95%. In both groups after the change, neither the biomarkers of inflammation nor the activity indices underwent significant changes at 3 and 6 months compared to the baseline value. Similarly, in both groups, infliximab trough levels showed a significant increase 3 and 6 months after the change to SC. No serious adverse events were registered. Conclusions: The CT-P13 SC brings a new anti-TNF era. Achieving much higher drug levels that are constant over time opens new paths to explore the management of patients with IBD: less immunogenicity, better perianal disease control and higher achievement of mucosal healing. MDPI 2022-08-30 /pmc/articles/PMC9495964/ /pubmed/36140230 http://dx.doi.org/10.3390/biomedicines10092130 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Huguet, Jose M.
García-Lorenzo, Victor
Martí, Lidia
Paredes, Jose María
Ramírez, Jose Joaquin
Pastor, Miguel
Ruiz, Lucia
Sanahuja, Ana
Timoneda, Pilar
Sanchís, Laura
Pérez, Gloria Alemany
Boscá-Watts, Marta Maia
Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study
title Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study
title_full Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study
title_fullStr Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study
title_full_unstemmed Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study
title_short Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study
title_sort subcutaneous infliximab [ct-p13], a true biologic 2.0. real clinical practice multicentre study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9495964/
https://www.ncbi.nlm.nih.gov/pubmed/36140230
http://dx.doi.org/10.3390/biomedicines10092130
work_keys_str_mv AT huguetjosem subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT garcialorenzovictor subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT martilidia subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT paredesjosemaria subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT ramirezjosejoaquin subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT pastormiguel subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT ruizlucia subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT sanahujaana subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT timonedapilar subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT sanchislaura subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT perezgloriaalemany subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy
AT boscawattsmartamaia subcutaneousinfliximabctp13atruebiologic20realclinicalpracticemulticentrestudy