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

A. Sepriano, A. Regel, D. Van Der Heijde, J. Braun, X. Baraliakos, R. Landewé, F. Van Den Bosch, L. Falzon, S. Ramiro

Research output: Contribution to journalReview article

27 Citations (Scopus)
14 Downloads (Pure)

Abstract

Objectives: To update the evidence for the efficacy and safety of (b)biological and (ts)targeted-synthetic disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) to inform the 2016 update of the Assessment of SpondyloArthritis international Society/European League Against Rheumatism (ASAS/EULAR) recommendations for the management of axSpA. Methods: Systematic literature review (2009-2016) for randomised controlled trials (RCT), including longterm extensions, strategy trials and observational studies (the latter was only for safety assessment and a comparator was required). Interventions were any bDMARD or tsDMARD. All relevant efficacy and safety outcomes were included. Results: 76 papers and 24 abstracts fulfilled the inclusion criteria. Large treatment effects were found both in radiographic axSpA (r-axSpA) and nonradiographic axSpA (nr-axSpA) for all tumour necrosis factor inhibitors (TNFi) (NNT to achieve ASAS40 response ranged between 2.6-5.2 for r-axSpA and 2.3-5.4 for nr-axSpA). For nr-axSpA, efficacy was superior for those who had objective signs of inflammation ( positive C reactive protein or inflammation on MRI-SI). Secukinumab 150 mg has shown efficacy in two phase 3 RCTs (NNT to achieve ASAS40 response: 3.4 and 4.0). Ustekinumab and tofacitinib have shown positive results in phase 2/proof-of-concept trials; trials with apremilast, rituximab, interleukin (IL)-6 antagonists and abatacept have failed their primary end points. New (unknown) safety signals were not found in the trials but longterm observational safety data for TNFi are still scarce. Conclusions: New evidence supports the efficacy and safety of TNFi both in r-axSpA and nr-axSpA. Secukinumab is the first drug targeting the IL-17 pathway in r-axSpA that has shown efficacy. © Published by the BMJ Publishing Group Limited.
Original languageEnglish
Pages (from-to)Online
Number of pages12
JournalRMD Open
Volume3
Issue number1
DOIs
Publication statusPublished - 27 Jan 2017

Keywords

  • DMARDs (biologic)
  • DMARDs (synthetic)
  • Spondyloarthritis
  • TNF-alpha
  • Treatment

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