Efficacy and safety of non-pharmacological and non-biological pharmacological treatment: a systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis

Andrea Regel; Alexandre Sepriano; Xenofon Baraliakos; Désirée van der Heijde; Jürgen Braun; Robert Landewé; Filip Van den Bosch; Louise Falzon; Sofia Ramiro

doi:10.1136/rmdopen-2016-000397

Efficacy and safety of non-pharmacological and non-biological pharmacological treatment: 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):e000397. doi: 10.1136/rmdopen-2016-000397. eCollection 2017.

Authors

Andrea Regel¹, Alexandre Sepriano², Xenofon Baraliakos¹, Désirée van der Heijde³, Jürgen Braun¹, Robert Landewé⁴, Filip Van den Bosch⁵, Louise Falzon⁶, Sofia Ramiro³

Affiliations

¹ Rheumazentrum Ruhrgebiet, Ruhr-University Bochum , Herne , Germany.
² Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; NOVA Medical School, Universidade Nova de Lisboa, Lisbon, Portugal.
³ Department of Rheumatology , Leiden University Medical Center , Leiden , The Netherlands.
⁴ Department of Clinical Immunology & Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Zuyderland Medical Center, Heerlen, The Netherlands.
⁵ Ghent University Hospital , Ghent , Belgium.
⁶ Center for Behavioral Cardiovascular Health, Columbia University Medical Center , New York, New York , USA.

Abstract

To assess the efficacy and safety of non-biological therapies in patients with axial spondyloarthritis (axSpA) to inform the update of the Assessment of SpondyloArthritis international Society (ASAS)/European League Against Rheumatism (EULAR) recommendations for the management of axSpA. A systematic literature review (2009-2016) of all non-pharmacological treatments, non-biological drugs (except targeted synthetic disease-modifying antirheumatic drugs (DMARDs)) and surgical therapies was performed. Randomised controlled trials (RCTs) and clinical controlled trials were assessed for efficacy and safety, while observational studies with a comparator were assessed for safety. All relevant efficacy and safety outcomes were included. Study heterogeneity precluded data pooling. If possible, Cohen's effect size was calculated for non-pharmacological treatments. In total, 45 papers and 2 abstracts were included. Studies on non-pharmacological treatments were very heterogeneous but overall confirmed a benefit for regular exercises, with small improvements in disease activity, function and spinal mobility. New studies on non-steroidal anti-inflammatory drugs (NSAIDs) confirmed their efficacy and new safety signals were not found. NSAIDs used continuously compared with on-demand did not reduce the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) mean change over 2 years in patients with ankylosing spondylitis with normal C reactive protein (CRP; ≤5 mg/L) (1 'negative' RCT (0.9 vs 0.8; p=0.62)), while for patients with high CRP, conflicting results were found (1 'positive' RCT (0.2 vs 1.7; p=0.003), 1 'negative' RCT (1.68 vs 0.96; p=0.28)). No new trials were found for conventional synthetic DMARDs (csDMARDs). Short-term high-dose systemic glucocorticoids showed limited efficacy. Regular exercises may improve several outcomes. Efficacy and safety of NSAIDs in axSpA are confirmed. Glucocorticoids are not proven to be effective in axSpA and new data on csDMARDs are lacking.

Keywords: Ankylosing Spondylitis; Spondyloarthritis; Treatment.

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