Danish infliximab switching study shows no difference

Biosimilars/Research | Posted 19/05/2017 post-comment0 Post your comment

A study published by researchers from Denmark has found that switching from originator to biosimilar infliximab has ‘no negative impact on disease activity’ [1].

56 AA011042

In May 2015, Denmark implemented a national guideline mandating non-medical switching of all patients treated with Remicade to Remsima. This observational study included 802 Danish rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis patients who were switched from the originator infliximab drug Remicade to the biosimilar infliximab product Remsima (CT-P13). The patients were followed for 413 (339−442) days.

The study evaluated disease activity and retention rates of patients in the nationwide quality registry, DANBIO. According to the authors, the results showed that disease activities were similar in the three months before and after switching and that the crude 1‑year retention rate for Remsima was similar to that for the historic Remicade cohort [84.1 (81.3−86.5) vs 86.2 (84.0−88.0), respectively]. Patients who had used Remicade for more than five years had longer Remsima retention.

The authors concluded that the ‘non-medical switch to CT-P13 had no negative impact on disease activity’. They added that this is the first study of large-scale, non-medical switching for a biosimilar in routine care with prospective data collection.

Related articles
NOR-SWITCH study finds biosimilar infliximab not inferior to originator

Pharmacovigilance of biologicals in Denmark

1. Glintborg B, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis. 2017 May 4. pii: annrheumdis-2016-210742. doi:10.1136/annrheumdis-2016-210742. [Epub ahead of print]

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010