Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2022 Mar 30;28(4):495-501.
doi: 10.1093/ibd/izab099.

Multiple Switches From the Originator Infliximab to Biosimilars Is Effective and Safe in Inflammatory Bowel Disease: A Prospective Multicenter Cohort Study

Jurij Hanzel  1   2 , Jeroen M Jansen  3 , Rinze W F Ter Steege  4 , Krisztina B Gecse  1 , Geert R D'Haens  1
Affiliations
Multicenter Study

Multiple Switches From the Originator Infliximab to Biosimilars Is Effective and Safe in Inflammatory Bowel Disease: A Prospective Multicenter Cohort Study

Jurij Hanzel et al. Inflamm Bowel Dis. .

Abstract

Background: Though a single nonmedical switch from the originator infliximab (IFX) to a biosimilar is considered effective and safe for most patients with inflammatory bowel disease (IBD), very limited data are available on multiple successive switches.

Methods: We performed a prospective multicenter cohort study of adult IBD patients who underwent 2 switches from the originator IFX to CT-P13 to SB2 (group 1), 1 switch from CT-P13 to SB2 (group 2), and 1 switch from the originator IFX to CT-P13 (group 3). Patients were assessed at 4 and 12 months since the most recent switch for remission using clinical (physician's assessment) and biochemical (C-reactive protein [CRP], and fecal calprotectin [FC]) measures. Patients discontinuing treatment for ineffectiveness or adverse events before month 12 were imputed as nonremitters.

Results: One hundred seventy-six patients (Crohn's disease 71%, ulcerative colitis 27.8%, IBD unclassified 1.2%; group 1, 69; group 2, 80; group 3, 27) were included. At 12 months after the most recent switch 76.9% (40 of 52, group 1), 65.7% (46 of 70, group 2) and 76.9% (20 of 26, group 3) of patients were in clinical remission. Treatment persistence at 12 months was 85.0%, 87.0%, and 70.1%, respectively. There were no significant differences in the rate of clinical, CRP, FC remission, or treatment persistence at 12 months between the 3 groups. Infusion reactions occurred in 1.7% of patients (3/176), all in patients with antidrug antibodies from group 2.

Conclusions: Multiple successive switching and switching between biosimilars of IFX seemed to be effective and safe.

Keywords: CT-P13; SB2; multiple switches.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Rates of clinical remission (A), C-reactive protein (CRP) < 5 mg/L (B), and fecal calprotectin <250 mg/kg (C) across the treatment groups at switch, 4, and 12 months following the most recent switch. Patients discontinuing treatment for inefficacy, appearance of antidrug antibodies, or adverse events were imputed as nonremitters at subsequent time points. Patients with missing biochemical measurements were censored.
Figure 2.
Figure 2.
Kaplan-Meier curves for treatment persistence in the 3 treatment groups. Patients discontinuing treatment for long-term sustained remission were censored at discontinuation.
See this image and copyright information in PMC

References

    1. Kim H, Alten R, Avedano L, et al. The future of biosimilars: maximizing benefits across immune-mediated inflammatory diseases. Drugs. 2020;80:99–113. - PMC - PubMed
    1. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72:1613–1620. - PMC - PubMed
    1. Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72:1605–1612. - PMC - PubMed
    1. Shin D, Kim Y, Kim YS, et al. A Randomized, Phase I pharmacokinetic study comparing SB2 and infliximab reference product (Remicade(®)) in healthy subjects. Biodrugs. 2015;29:381–388. - PMC - PubMed
    1. Choe JY, Prodanovic N, Niebrzydowski J, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76:58–64. - PMC - PubMed

Publication types

MeSH terms