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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

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Resumo: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.
Autores principais:Sepriano, A.
Outros Autores:Sepriano, Alexandre; Regel, A.; Van Der Heijde, D.; Braun, J.; Baraliakos, X.; Landewé, R.; Van Den Bosch, F.; Falzon, L.; Ramiro, S.; Ramiro, Sofia
Assunto:DMARDs (biologic) DMARDs (synthetic) Spondyloarthritis TNF-alpha Treatment
Ano:2017
País:Portugal
Tipo de documento:recensão
Tipo de acesso:acesso aberto
Instituição associada:Universidade Nova de Lisboa
Idioma:inglês
Origem:Repositório Institucional da UNL

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