Evidence map›Paper›PMID 28176964›Full record

ArticleRMD open2017

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.

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

Open access · goldAbstract read
In one paragraph

Article in RMD open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 6 pooled it
14.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 6 syntheses or guidelines pooled it, 119 citations in OpenAlex.

  1. The use of PROMIS measures in clinical studies in patients with inflammatory arthritis: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
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  20. Bone Involvement in Patients with Spondyloarthropathies.Calcified tissue international · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 5 countries.

Alexandre SeprianoDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal.ORCID 0000-0003-1954-0229
Andrea RegelRheumazentrum Ruhrgebiet, Ruhr-University Bochum , Herne , Germany.
Désirée van der HeijdeDepartment of Rheumatology , Leiden University Medical Center , Leiden , The Netherlands.
Jürgen BraunRheumazentrum Ruhrgebiet, Ruhr-University Bochum , Herne , Germany.
Xenofon BaraliakosRheumazentrum Ruhrgebiet, Ruhr-University Bochum , Herne , Germany.
Robert LandewéDepartment of Clinical Immunology & Rheumatology, Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands; Zuyderland Medical Center, Heerlen, The Netherlands.
Filip Van den BoschGhent University Hospital , Ghent , Belgium.
Louise FalzonCenter for Behavioral Cardiovascular Health , Columbia University Medical Center , New York , USA.
Sofia RamiroDepartment of Rheumatology , Leiden University Medical Center , Leiden , The Netherlands.
Leiden University Medical Center · NLRheumazentrum Ruhrgebiet · DEColumbia University Irving Medical Center · USGhent University Hospital · BEZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo 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.

methodsSystematic literature review (2009-2016) for randomised controlled trials (RCT), including long-term 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.

results76 papers and 24 abstracts fulfilled the inclusion criteria. Large treatment effects were found both in radiographic axSpA (r-axSpA) and non-radiographic 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 long-term observational safety data for TNFi are still scarce.

conclusionsNew 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.

Indexed as

DMARDs (biologic)DMARDs (synthetic)SpondyloarthritisTNF-alphaTreatment

Identifiers

PMID28176964
PMCPMC5278329
OpenAlexW2581314910

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.