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Switching may not be suitable for patients with immunogenicity Posted 30/09/2016

Results of a study of antibodies to infliximab comparing both the originator (Remicade ) and biosimilar (Inflectra/Remsima; CT-P13) versions has shown ‘cross-immunogenicity’ between the originator and biosimilar in patients with rheumatic diseases [1].

The data was presented at the European League against Rheumatism (EULAR) 2016 Congress held in London, UK on 8−11 June 2016.

The study included 250 patients with active rheumatoid arthritis (RA) and spondyloarthritis (SpA) being treated with Remicade and never exposed to the biosimilar (CT-P13) were retrospectively selected according to clinical information and anti-drug antibody (ADA) status. The patients included 37 infliximab-naïve rheumatic patients, 19 infliximab-naïve rheumatic patients with anti-adalimumab antibodies (AAA) and 21 healthy individuals – included as controls.

In total, 131 patients (52.4%) out of 250 Remicade-treated patient samples tested positive for anti-infliximab antibodies. All were also positive for infliximab antibodies when either Inflectra or Remicade bridging assays was used.

The authors from Spanish biopharma company Progenika Biopharma say that ‘this is the first study that demonstrates cross-immunogenicity between Remicade and a biosimilar molecule in patients with rheumatic diseases’. They add that the results ‘are in agreement with previous data in patients with inflammatory bowel diseases’.

This cross-reactivity, according to the authors, ‘suggests that the epitopes raising the immune response to the [originator] drug are responsible for the same degree of reactivity when sera are confronted [with] the biosimilar molecule’. They point out, however, that ‘it must be noted that the biosimilar might present new epitopes due to different glycosylation pattern or impurities, and even conformational epitopes due to potential aggregations’.

The authors believe that the findings in this study support the need for therapeutic drug monitoring before switching is considered. They therefore state that patients with infliximab antibodies treated with Remicade ‘should not be switched to a biosimilar treatment, since pre-existing infliximab antibodies will interact with the new drug, enhance clearance and potentially lead to loss of response and infusion-related reactions’.

The authors also call for further studies to be carried out with patients treated with biosimilars in order ‘to increase our knowledge about potentially different immunogenic responses’.

The Norwegian study, NOR-SWITCH, was announced in January 2014 and will compare Johnson & Johnson’s and Merck’s rheumatoid arthritis blockbuster Remicade (infliximab) to Celltrion’s biosimilar Inflectra (infliximab) [2]. Then August 2015 the BIO-SWITCH study, investigating the effects of switching patients from originator infliximab to biosimilar infliximab, was started in The Netherlands [3].

Conflict of interest
Some of the authors of the abstract [1] are employees of Progenika Biopharma. For full details of the authors’ conflicts of interest see the abstract [1].

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Related article
Assessing the immunogenicity of monoclonal antibodies

References
1. Ruiz-Argüello B, et al. Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilar CT-P13. Ann Rheum Dis. 2016;75(Suppl2):58.
2. 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 2016 Sep 30]. Available from: www.gabionline.net/Biosimilars/General/Norwegian-study-hopes-to-increase-biosimilars-uptake-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Another infliximab switching trial started [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 30]. Available from: www.gabionline.net/Biosimilars/News/Another-infliximab-switching-trial-started

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