NOR SWITCH
Switching from the original preparation to a biosimilar medicine in 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 examined the transition from originator infliximab to biosimilar CT-P13 in patients on stable long-term treatment, with regard to efficacy, safety and immunogenicity. 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 ended.
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 INCLUDE?
Patients from 40 Norwegian study centers were randomized 1:1 to either continue the original preparation or switch to CT-P13 treatment, with an unchanged dosage 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 thus no worse than continuing treatment with the original preparation. The study became a landmark in that it showed the benefit and safety of switching from expensive original drugs to less expensive biosimilars. The main results were published in The Lancet in 2017. A 26-week extension study was published in 2019, showing continued good response and safety of infliximab biopersistent treatment after the switch.