NOR SWITCH
Switching from the original preparation to a biosimilar medicine to patients with inflammatory disease of the joints, intestines or skin.
Project managers
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ABOUT THE PROJECT
The NOR-SWITCH study was led by Diakonhjemmet Hospital and investigated the efficacy, safety and immunogenicity of switching from the originator infliximab to the biosimilar CT-P13 in patients on stable long-term treatment. The study is a randomized, non-inferiority, double-blind study with 52 weeks of follow-up and a 26-week extension study.
WHO CAN JOIN?
The study has been completed.
Adult patients from all six disease indications for infliximab, on stable treatment with the original infliximab preparation and treated for at least 6 months, were eligible.
WHAT DOES THE STUDY INVOLVE?
Patients from 40 Norwegian study centers were randomized 1:1 to either continue with the original drug or switch to CT-P13 treatment, with an unchanged dosing regimen.
The primary endpoint was disease progression during 52 weeks of follow-up. 482 patients were randomized. Disease progression occurred in 53 (26%) patients in the original group and 61 (30%) patients in the CT-P13 group. Switching from infliximab original to CT-P13 was therefore non-inferior to continued treatment with the original preparation. The study became a landmark in that it demonstrated the benefit and safety of switching from expensive original medicines to less expensive biosimilars. The main results were published in The Lancet in 2017. A 26-week extension study was published in 2019, and showed continued good response and safety with infliximab biosimilar treatment after the switch.