Observational Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 14, 2018; 24(46): 5288-5296
Published online Dec 14, 2018. doi: 10.3748/wjg.v24.i46.5288
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, Vicente Merino Bohórquez, Miguel Angel Calleja, Ángel Caunedo Álvarez, Ángel Vilches Arenas
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. farguelles@telefonica.net
Telephone: +34-61-7348501
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
Processing time: 106 Days and 18.3 Hours
Abstract
BACKGROUND

Infliximab original has changed the natural history of inflammatory bowel diseases (IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited.

AIM

To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD.

METHODS

An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar (CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar.

RESULTS

98 patients (CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar (P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar (P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar.

CONCLUSION

The overall efficacy and loss of treatment response with infliximab biosimilar (CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.

Keywords: Crohn’s disease; Ulcerative colitis; CT-P13; Inflammatory bowel disease; Biosimilar agent; Infliximab original; Efficacy

Core tip: Although not strictly necessary, there are few studies comparing efficacy and safety of the switch from infliximab original (Remicade®) to infliximab biosimilar CT-P13 vs the maintenance of the original infliximab. For this reason, we presented a comparative study with the original infliximab. Our observational study demonstrates the real-life clinical results of efficacy and safety of infliximab original and the efficacy and safety after switching from original infliximab to infliximab biosimilar CT-P13 at the 12 mo follow-up. Our results demonstrate there is no statistical difference in remission rate, secondary loss of response or adverse events between both therapies.