Evidence map›Paper›PMID 30621746›Full record

Trial reportArthritis research & therapy2019

Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis.

Jordi Gratacós, Caridad Pontes, Xavier Juanola, Jesús Sanz, Ferran Torres, Cristina Avendaño, Antoni Vallano, Gonzalo Calvo, Eugenio de Miguel, Raimon Sanmartí and 1 more

3 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 24 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 5 pooled it
6.3field-weighted citation impact, top 3% 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.

NCT01604629 phase4completednot on this map

Evaluation of Clinical Value of Standardized Protocol for Dose-reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy: Open-label, Controlled, Randomized, Multicenter Trial.

TypeinterventionalSponsorSpanish Clinical Pharmacology SocietyRan2012 to 2015Enrolled120ConditionsSpondylarthropathiesArmsReduced doses of anti-TNF, Stable doses of anti-TNF
NCT04399382 unknown statusnot on this mapstarted 2022, after this paper: background citation

A Clinical Study Using Damage-associated Molecular Pattern and Apparent Diffusion Coefficient to Evaluate the Efficacy of Biologics for Treating Spondyloarthritis

TypeobservationalSponsorThe University of Hong Kong-Shenzhen HospitalRan2022 to 2022Enrolled40ConditionsSpondyloarthritis (SpA)ArmsBiologics
NCT05115903 phase4unknown statusnot on this mapstarted 2021, after this paper: background citation

A Prospective, Randomized Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis

TypeinterventionalSponsorUniversity Health Network, TorontoRan2021 to 2024Enrolled15ConditionsAxial SpondyloarthritisArmsTapered doses of TNFi, Standard dose of TNFi
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 5 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. La Tunisie medicale · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Jordi GratacósRheumatology Department, Hospital de Sabadell, Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, Sabadell, Barcelona, Spain.
Caridad PontesClinical Pharmacology Unit, Hospital de Sabadell, Institut Universitari Parc Taulí, Universitat Autònoma de Barcelona, c/Taulí n°1, 08208, Sabadell, Barcelona, Spain. caridad.pontes@uab.cat.ORCID 0000-0002-3274-6048
Xavier JuanolaRheumatology Department, Hospital Universitario de Bellvitge, Universitat de Barcelona, Bellvitge, Barcelona, Spain.
Jesús SanzRheumatology Department, Hospital Universitario Puerta de Hierro- Majadahonda, Madrid, Spain.
Ferran TorresMedical Statistics core facility, IDIBAPS, Hospital Clínic, Biostatistics Unit, School of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
Cristina AvendañoClinical Pharmacology Department, Hospital Puerta de Hierro Majadahonda, Madrid, Spain.
Antoni VallanoClinical Pharmacology Department, Hospital Universitario de Bellvitge - Universitat de Barcelona, Barcelona, Spain.
Gonzalo CalvoClinical Pharmacology Department, Hospital Clínic de Barcelona - Universitat de Barcelona, Barcelona, Spain.
Eugenio de MiguelRheumatology Department, Hospital Universitario La Paz, Madrid, Spain.
Raimon SanmartíRheumatology Department, Hospital Clínic de Barcelona - Universitat de Barcelona, Barcelona, Spain.
REDES-TNF investigators
Bellvitge University Hospital · ESUniversitat Autònoma de Barcelona · ESHospital Universitario La Paz · ESHospital Clínic de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective was to determine if dose reduction is non-inferior to full-dose TNFi to maintain low disease activity (LDA) in patients already in remission with TNFi, in axial spondyloarthritis.

methodsRandomized, parallel, non-inferiority, open-label multicentre clinical trial. Patients were eligible if they had axial spondyloarthritis and had been in clinical remission for ≥ 6 months with any available TNFi (adalimumab, etanercept, infliximab, golimumab) at the dose recommended by product labelling. Patients were randomized by automated central allocation to continue the same TNFi dose schedule, or to reduce the dose by roughly half according to the protocol. The main outcome was the proportion of subjects with LDA after 1 year. Serious adverse reactions or infections were recorded.

resultsThe trial stopped due to end of the funding period, after 126 patients were randomized; 113 patients (84.1% male, mean age (SD) 45.6 (13.0) years) were included in the main per-protocol subset. Non-inferiority was concluded for LDA at 1 year (47/55 (83.8%) patients in the full-dose and 48/58 (81.3%) patients in the reduced-dose arm, adjusted difference (95% CI) - 2.5% (- 16.6% to 11.7%)). Serious adverse reactions or infections were reported in 7/62 patients (11.3%) assigned to full dose and 2/61 patients (3.3%) assigned to reduced dose (p value = 0.164).

conclusionIn patients with ankylosing spondylitis in clinical remission for at least 6 months, dose reduction is non-inferior to full TNF inhibitor doses to maintain LDA after 1 year. Serious adverse events may be less frequent with reduced doses.

trial registrationEU Clinical Trials Registry, EudraCT 2011-005871-18 and ClinicalTrials.gov, NCT01604629 .

Indexed as

AdalimumabAdultAntibodies, MonoclonalDose-Response Relationship, DrugEtanerceptFemaleHumansInfliximabMaleMiddle AgedProspective StudiesSpondylarthritisTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsAdalimumabAntibodies, MonoclonalEtanerceptgolimumabInfliximabTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsDose-taperingNon-inferioritySpondyloarthritisTNF inhibitors

Identifiers

PMID30621746
PMCPMC6323809
OpenAlexW2911795323

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.