AI Article Synopsis
- Infliximab (IFX) biosimilars are used to treat inflammatory bowel disease (IBD) and are generally cheaper than original IFX, but concerns about switching between the two products persist.
- A systematic review of studies conducted between 2012 and 2022 found that switching from originator to biosimilar IFX did not significantly affect treatment effectiveness or safety, with reported adverse events being consistent with known profiles.
- Most studies concluded that outcomes for clinical effectiveness, patient-reported results, and safety after switching were comparable to those of the original IFX, although there is limited data on patients who switch multiple times.
Article Abstract
Introduction: Infliximab (IFX) biosimilars are available to treat inflammatory bowel disease (IBD), offering cost reductions versus originator IFX in some jurisdictions. However, concerns remain regarding the efficacy and safety of originator-to-biosimilar switching. This systematic literature review evaluated safety and effectiveness of switching between IFX products in patients with IBD, including multiple switchers.
Methods: Embase, PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials were searched to capture studies (2012-2022) including patients with IBD who switched between approved IFX products. Effectiveness outcomes: disease activity; disease severity; response to treatment; patient-reported outcomes (PROs). Safety outcomes: incidence and rate of adverse events (AEs); discontinuations due to AEs, failure rate; hospitalizations; surgeries. Immunogenicity outcomes (n, %): anti-drug antibodies; patients receiving concomitant immunomodulatory medication.
Results: Data from 85 publications (81 observational, two randomized controlled trials) were included. Clinical effectiveness outcomes were consistent with the known profile of originator IFX with no difference after switching. There were no unexpected/serious AEs after switching, and rates of AEs were generally consistent with the known profile of IFX.
Conclusions: Most studies reported that clinical, PROs, and safety outcomes for originator-to-biosimilar switching were clinically equivalent to originator responses. Limited data are available regarding multiple switches.
Protocol Registration: www.crd.york.ac.uk/prospero identifier is CRD42021289144.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1080/14712598.2024.2378090 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Microbiome characterization of patients with Crohn disease and the use of fecal microbiota transplantation: A review.
Medicine (Baltimore)
January 2025
Department of Gastroenterology, The Second Affiliated Hospital of Hainan Medical University, Haikou, China.
Inflammatory bowel disease is a chronic inflammatory condition predominantly affecting the intestines, encompassing both ulcerative colitis and Crohn disease (CD). As one of the most common gastrointestinal disorders, CD's pathogenesis is closely linked with the intestinal microbiota. Recently, fecal microbiota transplantation (FMT) has gained attention as a potential treatment for CD, with the effective reestablishment of intestinal microecology considered a crucial mechanism of FMT therapy.
View Article and Find Full Text PDFLow regulatory T-cells frequency is associated with graft rejection after small bowel transplantation: Clinical and experimental evidence.
PLoS One
January 2025
Transplant Group, La Paz University Hospital Health Research Institute (IdiPAZ), Madrid, Spain.
Background: Intestinal transplantation (ITx) represents the only curative option for patients with irreversible intestinal failure. Nevertheless, its rejection rate surpasses that of other solid organ transplants due to the heightened immunological load of the gut. Regulatory T-cells (Tregs) are key players in the induction and maintenance of peripheral tolerance, suggesting their potential involvement in modulating host vs.
View Article and Find Full Text PDFIncidence rates of tuberculosis and inflammatory bowel disease in patients with ankylosing spondylitis treated with biologics in Korea.
Rheumatology (Oxford)
January 2025
Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Objective: To describe the incidence rates of inflammatory bowel disease (IBD) and tuberculosis (TB) in Korean patients with ankylosing spondylitis receiving biologics.
Methods: Data from a Korean claims database between 2010 and 2021 was used to calculate crude incidence rates of TB and IBD using number of events and total patient-years (PYs).
Results: Overall, 43 643 and 43 396 patients were included in TB and IBD cohorts.
Editorial: Development and Validation of a Multimodal Machine Learning Model for Diagnosing and Assessing Risk of Crohn's Disease in Patients With Perianal Fistulae: Authors' Reply.
Aliment Pharmacol Ther
January 2025
Inflammatory Bowel Disease Center/Department of Colorectal Surgery, Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
The use of the Crohn's disease exclusion diet (CDED) in adults with Crohn's disease: A randomized controlled trial.
Eur J Clin Invest
January 2025
Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy.
Background: The Crohn's disease exclusion diet (CDED) has been shown to induce remission in adult Crohn's disease (CD) patients. The aim of the study is to provide additional evidence-based validation.
Methods: We conducted an open-label, randomized trial on adult CD patients with mild-to-moderate symptoms to assess CDED efficacy in inducing symptomatic remission using Mediterranean diet as control.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!