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. 2023 Jan;82(1):142-152.
doi: 10.1136/ard-2022-223297. Epub 2022 Oct 19.

Efficacy and safety of non-pharmacological and non-biological interventions: a systematic literature review informing the 2022 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis

Augusta Ortolan  1   2 , Casper Webers  3   4 , Alexandre Sepriano  5   6 , Louise Falzon  7 , Xenofon Baraliakos  8 , Robert Bm Landewé  9   10 , Sofia Ramiro  5   10 , Désirée van der Heijde  5 , Elena Nikiphorou  5   11   12
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Efficacy and safety of non-pharmacological and non-biological interventions: a systematic literature review informing the 2022 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis

Augusta Ortolan et al. Ann Rheum Dis. 2023 Jan.

Abstract

Objective: To update the evidence of non-biological treatments for axial spondyloarthritis (axSpA), as a basis for the 2022 Assessment of SpondyloArthritis international Society-European Alliance of Associations for Rheumatology (ASAS-EULAR) recommendations for the management of axSpA.

Methods: A systematic literature review (2016-2021) on efficacy and safety of non-pharmacological and non-biological pharmacological treatments was performed, up to 1 January 2022. The research question was formulated according to the PICO format: Population: adult patients with r-axSpA and nr-axSpA; Intervention: non-pharmacological and non-biological pharmacological treatments; Comparator: active comparator or placebo; Outcomes: all relevant efficacy and safety outcomes. Type of studies included were: randomised controlled trials (RCTs), observational studies (for efficacy of non-pharmacological treatments, and safety), qualitative studies. Cohen's effect size (ES) was calculated for non-pharmacological and risk ratio (RR) for pharmacological treatments.

Results: Of 107 publications included, 63 addressed non-pharmacological interventions, including education (n=8) and exercise (n=20). The ES for education on disease activity, function, mobility was small to moderate (eg. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), ES: 0.06-0.59). Exercise had moderate to high ES on these outcomes (eg.

Basdai, es: 0.14-1.43). Six RCTs on targeted synthetic disease-modifying antirheumatic drugs (DMARDs) showed efficacy of tofacitinib, upadacitinib and filgotinib (phase 2 only) in r-axSpA (range RR vs placebo for ASAS20: 1.91-3.10), while apremilast and nilotinib were not efficacious. Studies on conventional synthetic DMARDs (n=3), non-steroidal anti-inflammatory drugs (NSAIDs, n=8) and other drugs (n=12) did not provide new evidence on efficacy/safety (efficacy of NSAIDs confirmed; limited efficacy of short-term glucocorticoids in one RCT).

Conclusions: Education, exercise and NSAIDs confirmed to be efficacious in axSpA. JAKi were proved efficacious in r-axSpA.

Keywords: Anti-Inflammatory Agents, Non-Steroidal; Glucocorticoids; Physical Therapy Modalities; Spondylitis, Ankylosing.

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Conflict of interest statement

Competing interests: CW and AO have nothing to declare. AS has received speaker/consulting fees from UCB and Novartis. XB received consulting fees and research grants from Abbvie, BMS, Eli-Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB and is an Editorial Board member of Annals of Rheumatic Diseases. RL is EULAR Council member and chair of Quality of Care, has received consulting fees from AbbVie, Bristol Myers Squibb, Jansen, Galapagos, Gilead, Glaxo-Smith-Kline, Novartis, Pfizer, UCB and is Director of Rheumatology Consultancy BV. SR received research grants from AbbVie, Galapagos, Novartis, Pfizer and UCB, and consulting fees from AbbVie, Eli Lilly, Novartis, MSD, Pfizer, UCB and Sanofi. DvdH received consulting fees from AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma and is Director of Imaging Rheumatology BV. She is associate editor of Annals of Rheumatic Diseases and Editorial Board member of Journal of Rheumatology. EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Lilly and holds research grants from Pfizer and Lilly.

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