Data presented today at United European Gastroenterology Week in Vienna adds to the growing body of real-world evidence that supports switching patients from reference infliximab to biosimilar infliximab.Remsima®, an infliximab biosimilar, was shown to be non-inferior to its reference product Remicade® in adult patients who had been switched to receive treatment with Remsima® for 52 weeks. All participants had been on stable treatment with the reference product for at least six months prior to switch.
The data comes from an independent study sponsored by the Norwegian government (NOR-SWITCH), which was designed to assess the efficacy, safety and immunogenicity of switching adult patients to Remsima®.
NOR-SWITCH is a randomised, double-blind, controlled, parallel-group, multicentre, Phase IV, non-inferiority comparative study. It is the first randomised controlled trial (RCT) to assess disease worsening across all adult indications in patients switched from Remicade® to Remsima®. NOR-SWITCH enrolled 481 people aged 18 years or older diagnosed with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease or chronic plaque psoriasis.
Co-author of the study, Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway, said: “Biosimilars such as Remsima® have the potential to save healthcare systems significant sums of money and increase patient access to life-changing treatments, but this can only happen if prescribers have the confidence that the biosimilar is genuinely comparable to the reference product. This study adds to the body of real-life evidence from the clinic that switching people to biosimilar infliximab is effective and well tolerated across the range of different conditions we prescribe it for. This suggests that a wide range of patients can be effectively switched to Remsima® with a significant cost saving to healthcare systems.”
Patients who had been receiving Remicade® for at least six months were randomised 1:1 to either continue treatment with the reference productor to be switched to Remsima® using an unchanged dosing regimen. Data were collected at infusion visits.
The primary endpoint was disease worsening during follow-up, determined by disease-specific composite measures and/or consensus between the patient and physician leading to a major change in treatment. Disease worsening occurred in 53 (26.2%) patients in the Remicade® arm and 61 (29.6%) patients in the Remsima® arm. The 95% confidence interval of the adjusted treatment difference (-4.4%) was -12.7 – 3.9 which was within the pre-specified non-inferiority margin.1
The incidence of anti-drug antibodies detected was 17 (7.1%) in patients taking Remicade® and 19 (7.9%) in those taking Remisima®. Patients experienced similar frequencies of adverse events, including infusion reactions across both arms of the study.1
1. Jørgensen K et al. (2016) ‘LB15 – Biosimilar infliximab (CT-P13) is not inferior to originator infliximab: results from the 52-week randomized NOR-SWITCH trial.’ Abstract presented at the United European Gastroenterology (UEG) Week meeting 2016, 15-19 October, Vienna, Austria