Multiple switches from the originator infliximab to biosimilars is effective and safe in inflammatory bowel disease : a prospective multicenter cohort study

Hanžel, Jurij (author), Jansen, Jeroen M. (author), ter Steege, Rinze W. F. (author), Gecse, Krisztina B. (author), D'Haens, Geert R. (author)

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.

• Language: English
• Keywords: SB2, CT-P13, multiple switches, Crohn's disease, inflammatory bowel disease, ulcerative colitis, adults, feces, c-reactive protein, infliximab, adverse event, leukocyte l1 antigen complex, infusion procedures, biosimilar pharmaceuticals, disease remission, imputation, antidrug antibody, infliximab-dyyb
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2022
• Number of pages: Str. 495-501
• Numbering: Vol. 28, iss. 4
• PID: 20.500.12556/RUL-141896
• UDC: 616.3
• ISSN on article: 1536-4844
• DOI: 10.1093/ibd/izab099
• COBISS.SI-ID: 65359363
• Publication date in RUL: 11.10.2022

Record is a part of a journal

• Title: Inflammatory bowel diseases
• Shortened title: Inflamm. bowel dis.
• Publisher: Oxford University Press, Crohn’s & Colitis Foundation
• ISSN: 1536-4844
• COBISS.SI-ID: 519035417

Licences

• License: CC BY-NC 4.0, Creative Commons Attribution-NonCommercial 4.0 International
• Link: http://creativecommons.org/licenses/by-nc/4.0/
• Description: A creative commons license that bans commercial use, but the users don’t have to license their derivative works on the same terms.

Secondary language

• Language: Slovenian
• Keywords: Chronova bolezen, infliksimab, biološka zdravila, gastroenterologija