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Danish infliximab switching study shows no difference

Biosimilars/Research | Posted 19/05/2017 0 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].

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.

Pharmacovigilance of biologicals in Denmark

Reference
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]

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