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

被引：59

作者：

Webers, Casper ^{[1
,2
]}

Ortolan, Augusta ^{[3
,4
]}

Sepriano, Alexandre ^{[4
,5
]}

Falzon, Louise ^{[6
]}

Baraliakos, Xenofon ^{[7
]}

Landewe, Robert B. M. ^{[8
,9
]}

Ramiro, Sofia ^{[4
,9
]}

van der Heijde, Desiree ^{[4
]}

Nikiphorou, Elena ^{[4
,10
,11
]}

机构：

[1] Maastricht Univ, Dept Internal Med, Div Rheumatol, Med Ctr, Postbus 5800, NL-6202 AZ Maastricht, Netherlands

[2] Maastricht Univ, Care & Publ Hlth Res Inst CAPHRI, Maastricht, Netherlands

[3] Univ Padua, Dept Med DIMED, Rheumatol Unit, Padua, Italy

[4] Leiden Univ, Dept Rheumatol, Med Ctr, Leiden, Netherlands

[5] Univ Nova Lisboa, NOVA Med Sch, Lisbon, Portugal

[6] Univ Sheffield, Sch Hlth & Related Res, Hlth Econ & Decis Sci, Sheffield, S Yorkshire, England

[7] Ruhr Univ Bochum, Rheumazentrum Ruhrgebiet, Herne, Germany

[8] Univ Amsterdam, Dept Clin Immunol & Rheumatol, Med Ctr, Amsterdam, Netherlands

[9] Zuyderland Med Ctr Heerlen, Dept Rheumatol, Heerlen, Netherlands

[10] Kings Coll Hosp London, Dept Rheumatol, London, England

[11] Kings Coll London, Ctr Rheumat Dis, London, England

来源：

ANNALS OF THE RHEUMATIC DISEASES | 2023年 / 82卷 / 01期

关键词：

spondylitis; ankylosing; biological therapy; tumour necrosis factor inhibitors; axial spondyloarthritis; ACTIVE ANKYLOSING-SPONDYLITIS; MEDIATED INFLAMMATORY DISEASES; FACTOR INHIBITOR TREATMENT; ANTI-TNF AGENTS; LONG-TERM; DOUBLE-BLIND; CERTOLIZUMAB PEGOL; OPEN-LABEL; ETANERCEPT TREATMENT; CONSENSUS STATEMENT;

D O I：

10.1136/ard-2022-223298

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objective To update the evidence on efficacy and safety of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with axial spondyloarthritis (axSpA) to inform the 2022 update of the Assessment of SpondyloArthritis international Society/European Alliance of Associations for Rheumatology (ASAS-EULAR) recommendations for the management of axSpA. Methods Systematic literature review (2016-2021) on efficacy and safety of bDMARDs in axSpA (radiographic axSpA (r-axSpA)/non-radiographic axSpA (nr-axSpA)). Eligible study designs included randomised controlled trials (RCTs), strategy trials and observational studies (the latter only for safety and extra-musculoskeletal manifestations). All relevant efficacy/safety outcomes were included. Results In total, 148 publications were included. Efficacy of golimumab and certolizumab was confirmed. Tumour necrosis factor inhibitor (TNFi) biosimilar-originator equivalence was demonstrated. RCT (n=15) data on efficacy of interleukin-17 inhibitors (IL-17i) demonstrated clinically relevant effects (risk ratio vs placebo to achieve ASAS40 response 1.3-15.3 (r-axSpA, n=9), 1.4-2.1 (nr-axSpA, n=2)). Efficacy of secukinumab/ixekizumab was demonstrated in TNFi-naive and TNFi-inadequate responders. IL-23 and IL-12/23 inhibitors (risankizumab/ustekinumab) failed to show relevant benefits. Tapering of TNFi by spacing was non-inferior to standard-dose treatment. The first axSpA treat-to-target trial did not meet its primary endpoint, but showed improvements in secondary outcomes. No new risks were identified with TNFi use in observational studies (data lacking for IL-17i). Secukinumab (n=1) and etanercept (n=2) were associated with increased risk of uveitis in observational studies compared to monoclonal TNFi. Conclusions New evidence supports the efficacy and safety of TNFi (originators/biosimilars) and IL-17i in r-axSpA and nr-axSpA, while IL-23i failed to show relevant effects. Observational studies are needed to confirm long-term IL-17i safety. PROSPERO registration number CRD42021257588

引用

页码：130 / 141

页数：12

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