The first study of this kind was started in Norway. The NOR-SWITCH study is designed to generate safety and efficacy data to reassure physicians that the biosimilar version is just as good and that could facilitate greater switching of patients who are already receiving the originator product, Johnson & Johnson’s and Merck’s rheumatoid arthritis blockbuster Remicade (infliximab) [1].

Similarly this new study in The Netherlands aims to gain information on the effect of switching treatment from originator infliximab to biosimilar infliximab on efficacy, safety and immunogenicity in patients with rheumatoid arthritis, spondyloarthritis or psoriatic arthritis in daily clinical care.

The study will enrol 200 rheumatoid arthritis, spondyloarthritis or psoriatic arthritis patients who are currently treated with Remicade. The patients will be informed about the option to switch to infliximab biosimilar. Both patients who switch treatment to biosimilar infliximab (switch group) and patients who do not switch treatment (control group) will be asked to participate in this study.

The primary efficacy endpoint will be the difference in mean DAS28-ESR and mean DAS28-CRP (for rheumatoid and psoriatic arthritis) and mean BASDAI (for spondyloarthritis) between baseline and follow-up (after six and 12 months of treatment with the biosimilar).

Secondary outcomes include the incidence of rheumatoid arthritis, psoriatic arthritis and spondyloarthritis patients with flare-ups at six and 12 months follow-up, as well as evaluation of safety and immunogenicity.

The open, parallel group, observational, BIO-SWITCH study is planned to be completed in April 2017.

Related article
Norwegian study may be slowing adoption of biosimilar infliximab

Reference
1.  GaBI Online - Generics and Biosimilars Initiative. Norwegian study hopes to increase biosimilars uptake in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 2]. Available from: www.gabionline.net/Biosimilars/General/Norwegian-study-hopes-to-increase-biosimilars-uptake-in-Europe

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