Evidence on biosimilar efficacy and safety leads to ASAS/EULAR recommendation

Biosimilars/Research | Posted 24/03/2017 post-comment0 Post your comment

A study of biological disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) found no reason for physicians not to prescribe infliximab biosimilars [1].

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The authors, who came from institutes across Europe and the US, carried out a systematic literature review to update the evidence for the efficacy and safety of DMARDs used to treat axSpA. The search covered randomized controlled trials (RCT), including long-term extensions, strategy trials and observational studies reported between 2009–2016 and included 76 papers and 24 abstracts. The evidence collected was then used to inform the 2016 update of the Assessment of SpondyloArthritis international Society/European League Against Rheumatism (ASAS/EULAR) recommendations for the management of axSpA.

The search confirmed the efficacy and safety of TNFi (including the new data on certolizumab pegol) in patients with radiographic (r-axSpA). It included data from a double-blind, randomized, controlled, non-inferiority trial (PLANETAS), which ‘has shown comparable efficacy and safety profiles between an infliximab biosimilar (CT‑P13) and an infliximab originator sustained up to 54 weeks of treatment’. The authors added that ‘CT-P13 … has been shown to be as effective and safe as an infliximab originator in patients with r-axSpA’.

This evidence, when presented to the ASAS/EULAR update group, led to the following statement on the management of axial spondyloarthritis:

‘The price of a DMARD should be taken into account when choosing a particular drug. The choice is very much dependent on local situations, and general recommendations cannot be made, but given the similar expected safety and efficacy with regard to alleviating musculoskeletal symptoms, cost is potentially an important consideration in making a choice between a boDMARD [biological originator] and a bsDMARD [biosimilar]’ [2].

Conflict of interest
The authors of the research paper [1] received funding from EULAR. For full details of the authors’ conflict of interest, see the research paper [1].

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1. Sepriano A, et al. Efficacy and safety of biological and targeted-synthetic DMARDs: a systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis. RMD Open. 2017 Jan 27;3(1):e000396. doi:10.1136/rmdopen-2016-000396. eCollection 2017.
2. van der Heijde D, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017 Jan 13. pii: annrheumdis-2016-210770. doi:10.1136/annrheumdis-2016-210770. [Epub ahead of print]

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