Switching failures with biosimilar etanercept

Biosimilares/Investigación | Posted 12/01/2018 post-comment0 Post your comment

A study carried out by researchers from Denmark has found that switching from originator to biosimilar etanercept does not work for all patients [1].

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Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. It is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Biosimilar etanercept, Benepali (SB4) was approved by the European Commission on 14 January 2016 [2]. During 2016, non-medical switching of patients treated with originator etanercept (Enbrel) to Benepali was implemented in Denmark. The researchers from the King Christian X’s Hospital investigated how this switch affected patients in their outpatients department in June 2016. Clinical outcome measurements were recorded according to the Danish DANBIO registry for rheumatoid arthritis and ankylosing spondyloarthritis.

The results showed unchanged efficacy after switch in 76 out of 85 cases. However, in nine cases significant loss of efficacy (LOE) and/or adverse events (AEs) were recorded during the first four months after the switch.

Four of these patients were stable on Enbrel, but flare-ups (ASDAS>2.1 or DAS28CRP>3.2) were observed at least once during the 24-month period before the switch. Two of these patients were continued on Benepali and two were changed to a third biological treatment due to prolonged disease activity.

The other five patients had experienced complete remission for at least 2 (and up to 9) years on Enbrel but experienced one case of AE, three cases of LOE and one case of combined AE and LOE after the switch. In these cases the researchers ‘interpreted Benepali to be potentially causative and performed the switch back to Enbrel. All five patients regained complete remission without further adverse events’.

These data were presented at the American College of Rheumatology’s (ACR) 2017 Annual Meeting, which was held on 19−24 October 2017 in San Diego, CA, USA.

Conflict of interest
The authors of the abstract [1] reported conflicts of interest including AbbVie, Roche and Novartis. For full details of the authors’ conflict 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 as preliminary until published in a peer-reviewed journal.

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1. Hendricks O, Hørslev-Petersen K. When etanercept switch fails – clinical considerations. American College of Rheumatology’s (ACR) 2017 Annual Meeting; 19-24 October 2017; San Diego, CA, USA.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: ACR

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