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].
Evidence on biosimilar efficacy and safety leads to ASAS/EULAR recommendation
Biosimilars/Research | Posted 24/03/2017 0 Post your comment
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].
Editor’s comment
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.
Related articles
NOR-SWITCH study finds biosimilar infliximab not inferior to originator
Safety and efficacy of Remsima in IBD patients in clinical practice
References
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]
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.
General
Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
SBR issues consensus on interchangeability of reference products and biosimilars
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
Biosimilars in inflammatory bowel disease: are we ready for multiple switches
Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
Comments (0)
Post your comment