Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease

Shaden Mahmmod; Johannes P D Schultheiss; Ad A van Bodegraven; Gerard Dijkstra; Lennard P L Gilissen; Frank Hoentjen; Maurice W M D Lutgens; Nofel Mahmmod; Andrea E van der Meulen-de Jong; Lisa J T Smits; Adriaan C I T L Tan; Bas Oldenburg; Herma H Fidder

doi:10.1093/ibd/izaa364

Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease

Shaden Mahmmod, Johannes P D Schultheiss, Ad A van Bodegraven, Gerard Dijkstra, Lennard P L Gilissen, Frank Hoentjen, Maurice W M D Lutgens, Nofel Mahmmod, Andrea E van der Meulen-de Jong, Lisa J T Smits, Adriaan C I T L Tan, Bas Oldenburg, Herma H Fidder

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: Patients suffering from inflammatory bowel diseases (IBD) and treated with originator infliximab are increasingly being switched to biosimilars. Some patients, however, are "reverse switched" to treatment with the originator. Here we assess the prevalence of reverse switching, including its indication and outcomes.

METHODS: In this retrospective multicenter cohort study, data on patients with IBD from 9 hospitals in the Netherlands were collected. All adult patients with IBD were included if they previously had been switched from originator infliximab to the biosimilar CT-P13 and had a follow-up time of at least 52 weeks after the initial switch. The reasons for reverse switching were categorized into worsening gastrointestinal symptoms, adverse effects, or loss of response to CT-P13. Drug persistence was analyzed through survival analyses.

RESULTS: A total of 758 patients with IBD were identified. Reverse switching was observed in 75 patients (9.9%). Patients with reverse switching were predominantly female (70.7%). Gastrointestinal symptoms (25.5%) and dermatological symptoms (21.8%) were the most commonly reported reasons for reverse switching. In 9 patients (12.0%), loss of response to CT-P13 was the reason for reverse switching. Improvement of reported symptoms was seen in 73.3% of patients after reverse switching and 7 out of 9 patients (77.8%) with loss of response regained response. Infliximab persistence was equal between patients who were reverse-switched and those who were maintained on CT-P13.

CONCLUSIONS: Reverse switching occurred in 9.9% of patients, predominantly for biosimilar-attributed adverse effects. Switching back to originator infliximab seems effective in patients who experience adverse effects, worsening gastrointestinal symptoms, or loss of response after switching from originator infliximab to CT-P13.

Original language	English
Pages (from-to)	1954-1962
Number of pages	9
Journal	Inflammatory bowel diseases
Volume	27
Issue number	12
Early online date	4 Feb 2021
DOIs	https://doi.org/10.1093/ibd/izaa364
Publication status	Published - 1 Dec 2021

Keywords

Anti-TNF-alpha
Biologic therapy
Biosimilars
Crohn disease
Inflammatory bowel disease
Infliximab
Ulcerative colitis

Access to Document

10.1093/ibd/izaa364

Cite this

Mahmmod, S., Schultheiss, J. P. D., van Bodegraven, A. A., Dijkstra, G., Gilissen, L. P. L., Hoentjen, F., Lutgens, M. W. M. D., Mahmmod, N., van der Meulen-de Jong, A. E., Smits, L. J. T., Tan, A. C. I. T. L., Oldenburg, B., & Fidder, H. H. (2021). Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease. Inflammatory bowel diseases, 27(12), 1954-1962. https://doi.org/10.1093/ibd/izaa364

@article{9473434e79354a5aa22cca42d16bb34b,

title = "Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease",

abstract = "BACKGROUND: Patients suffering from inflammatory bowel diseases (IBD) and treated with originator infliximab are increasingly being switched to biosimilars. Some patients, however, are {"}reverse switched{"} to treatment with the originator. Here we assess the prevalence of reverse switching, including its indication and outcomes.METHODS: In this retrospective multicenter cohort study, data on patients with IBD from 9 hospitals in the Netherlands were collected. All adult patients with IBD were included if they previously had been switched from originator infliximab to the biosimilar CT-P13 and had a follow-up time of at least 52 weeks after the initial switch. The reasons for reverse switching were categorized into worsening gastrointestinal symptoms, adverse effects, or loss of response to CT-P13. Drug persistence was analyzed through survival analyses.RESULTS: A total of 758 patients with IBD were identified. Reverse switching was observed in 75 patients (9.9%). Patients with reverse switching were predominantly female (70.7%). Gastrointestinal symptoms (25.5%) and dermatological symptoms (21.8%) were the most commonly reported reasons for reverse switching. In 9 patients (12.0%), loss of response to CT-P13 was the reason for reverse switching. Improvement of reported symptoms was seen in 73.3% of patients after reverse switching and 7 out of 9 patients (77.8%) with loss of response regained response. Infliximab persistence was equal between patients who were reverse-switched and those who were maintained on CT-P13.CONCLUSIONS: Reverse switching occurred in 9.9% of patients, predominantly for biosimilar-attributed adverse effects. Switching back to originator infliximab seems effective in patients who experience adverse effects, worsening gastrointestinal symptoms, or loss of response after switching from originator infliximab to CT-P13.",

keywords = "Anti-TNF-alpha, Biologic therapy, Biosimilars, Crohn disease, Inflammatory bowel disease, Infliximab, Ulcerative colitis",

author = "Shaden Mahmmod and Schultheiss, {Johannes P D} and {van Bodegraven}, {Ad A} and Gerard Dijkstra and Gilissen, {Lennard P L} and Frank Hoentjen and Lutgens, {Maurice W M D} and Nofel Mahmmod and {van der Meulen-de Jong}, {Andrea E} and Smits, {Lisa J T} and Tan, {Adriaan C I T L} and Bas Oldenburg and Fidder, {Herma H}",

year = "2021",

month = dec,

day = "1",

doi = "10.1093/ibd/izaa364",

language = "English",

volume = "27",

pages = "1954--1962",

journal = "Inflammatory bowel diseases",

issn = "1078-0998",

publisher = "John Wiley & Sons Inc.",

number = "12",

}

Mahmmod, S, Schultheiss, JPD, van Bodegraven, AA, Dijkstra, G, Gilissen, LPL, Hoentjen, F, Lutgens, MWMD, Mahmmod, N, van der Meulen-de Jong, AE, Smits, LJT, Tan, ACITL, Oldenburg, B & Fidder, HH 2021, 'Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease', Inflammatory bowel diseases, vol. 27, no. 12, pp. 1954-1962. https://doi.org/10.1093/ibd/izaa364

TY - JOUR

T1 - Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease

AU - Mahmmod, Shaden

AU - Schultheiss, Johannes P D

AU - van Bodegraven, Ad A

AU - Dijkstra, Gerard

AU - Gilissen, Lennard P L

AU - Hoentjen, Frank

AU - Lutgens, Maurice W M D

AU - Mahmmod, Nofel

AU - van der Meulen-de Jong, Andrea E

AU - Smits, Lisa J T

AU - Tan, Adriaan C I T L

AU - Oldenburg, Bas

AU - Fidder, Herma H

PY - 2021/12/1

Y1 - 2021/12/1

N2 - BACKGROUND: Patients suffering from inflammatory bowel diseases (IBD) and treated with originator infliximab are increasingly being switched to biosimilars. Some patients, however, are "reverse switched" to treatment with the originator. Here we assess the prevalence of reverse switching, including its indication and outcomes.METHODS: In this retrospective multicenter cohort study, data on patients with IBD from 9 hospitals in the Netherlands were collected. All adult patients with IBD were included if they previously had been switched from originator infliximab to the biosimilar CT-P13 and had a follow-up time of at least 52 weeks after the initial switch. The reasons for reverse switching were categorized into worsening gastrointestinal symptoms, adverse effects, or loss of response to CT-P13. Drug persistence was analyzed through survival analyses.RESULTS: A total of 758 patients with IBD were identified. Reverse switching was observed in 75 patients (9.9%). Patients with reverse switching were predominantly female (70.7%). Gastrointestinal symptoms (25.5%) and dermatological symptoms (21.8%) were the most commonly reported reasons for reverse switching. In 9 patients (12.0%), loss of response to CT-P13 was the reason for reverse switching. Improvement of reported symptoms was seen in 73.3% of patients after reverse switching and 7 out of 9 patients (77.8%) with loss of response regained response. Infliximab persistence was equal between patients who were reverse-switched and those who were maintained on CT-P13.CONCLUSIONS: Reverse switching occurred in 9.9% of patients, predominantly for biosimilar-attributed adverse effects. Switching back to originator infliximab seems effective in patients who experience adverse effects, worsening gastrointestinal symptoms, or loss of response after switching from originator infliximab to CT-P13.

AB - BACKGROUND: Patients suffering from inflammatory bowel diseases (IBD) and treated with originator infliximab are increasingly being switched to biosimilars. Some patients, however, are "reverse switched" to treatment with the originator. Here we assess the prevalence of reverse switching, including its indication and outcomes.METHODS: In this retrospective multicenter cohort study, data on patients with IBD from 9 hospitals in the Netherlands were collected. All adult patients with IBD were included if they previously had been switched from originator infliximab to the biosimilar CT-P13 and had a follow-up time of at least 52 weeks after the initial switch. The reasons for reverse switching were categorized into worsening gastrointestinal symptoms, adverse effects, or loss of response to CT-P13. Drug persistence was analyzed through survival analyses.RESULTS: A total of 758 patients with IBD were identified. Reverse switching was observed in 75 patients (9.9%). Patients with reverse switching were predominantly female (70.7%). Gastrointestinal symptoms (25.5%) and dermatological symptoms (21.8%) were the most commonly reported reasons for reverse switching. In 9 patients (12.0%), loss of response to CT-P13 was the reason for reverse switching. Improvement of reported symptoms was seen in 73.3% of patients after reverse switching and 7 out of 9 patients (77.8%) with loss of response regained response. Infliximab persistence was equal between patients who were reverse-switched and those who were maintained on CT-P13.CONCLUSIONS: Reverse switching occurred in 9.9% of patients, predominantly for biosimilar-attributed adverse effects. Switching back to originator infliximab seems effective in patients who experience adverse effects, worsening gastrointestinal symptoms, or loss of response after switching from originator infliximab to CT-P13.

KW - Anti-TNF-alpha

KW - Biologic therapy

KW - Biosimilars

KW - Crohn disease

KW - Inflammatory bowel disease

KW - Infliximab

KW - Ulcerative colitis

UR - http://www.scopus.com/inward/record.url?scp=85103179023&partnerID=8YFLogxK

U2 - 10.1093/ibd/izaa364

DO - 10.1093/ibd/izaa364

M3 - Article

C2 - 33538298

SN - 1078-0998

VL - 27

SP - 1954

EP - 1962

JO - Inflammatory bowel diseases

JF - Inflammatory bowel diseases

IS - 12

ER -

Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this