Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar (CT-P13) in patients with inflammatory bowel disease
María Fernanda Guerra Veloz, Federico Argüelles-Arias, Luisa Castro Laria, Belén Maldonado Pérez, Antonio Benítez Roldan, Raúl Perea Amarillo, Ángel Caunedo Álvarez, Department of Gastroenterology, University Hospital Virgen Macarena, Seville 41007, Spain
Vicente Merino Bohórquez, Miguel Angel Calleja, Pharmacy Unit, University Hospital Virgen Macarena, Seville 41007, Spain
Ángel Vilches Arenas, Preventive Medicine and Public Health, University Hospital Virgen Macarena, Seville 41007, Spain
Author contributions: Guerra Veloz MF did the study design, data analysis and writing up of the first draft of the paper; Argüelles-Arias F did the data analysis and patient recruitment, Castro Laria L and Maldonado Pérez B did the patient recruitment; Perea Amarillo R and Merino Bohorquez V did the Data collection; Caunedo Álvarez Á did the study design; Vilches Arenas Á did the data analysis.
Institutional review board statement: The study was approved by the Research Ethics Committee of the Virgen Macarena Hospital, Seville, Spain.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Guerra Veloz MF, Castro Laria L, Maldonado Pérez B, Perea Amarillo R and Argüelles-Arias F have received financial support to attend scientific meetings from Kern Pharma. Benítez Roldán A, Merino Bohórquez V, Calleja MA, Caunedo Álvarez Á, and Vilches Arenas Á do not have conflict of interest.
Data sharing statement: No additional data are available.
STROBE statement: the guidelines of the STROBE Statement have been adopted
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author to: Federico Argüelles-Arias, PhD, Doctor, Professor, Department of Gastroenterology, University Hospital Virgen Macarena, Dr. Fedriani 3, Seville 41007, Spain. email@example.com
Received: August 29, 2018
Peer-review started: August 29, 2018
First decision: October 14, 2018
Revised: November 18, 2018
Accepted: December 7, 2018
Article in press: December 7, 2018
Published online: December 14, 2018