Evidence map›Paper›PMID 25858265›Full record

Trial reportBMJ (Clinical research ed.)2015

Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis: open label, randomised controlled, non-inferiority trial.

Noortje van Herwaarden, Aatke van der Maas, Michiel J M Minten, Frank H J van den Hoogen, Wietske Kievit, Ronald F van Vollenhoven, Johannes W J Bijlsma, Bart J F van den Bemt, Alfons A den Broeder

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 13 pooled it
19.0field-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

73 citing papers in PubMed, 13 syntheses or guidelines pooled it, 181 citations in OpenAlex.

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13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Noortje van HerwaardenDepartment of Rheumatology, Sint Maartenskliniek, Nijmegen, PO Box 9011, 6500 GM, Netherlands n.vanherwaarden@maartenskliniek.nl.
Aatke van der MaasDepartment of Rheumatology, Sint Maartenskliniek, Nijmegen, PO Box 9011, 6500 GM, Netherlands.
Michiel J M MintenDepartment of Rheumatology, Sint Maartenskliniek, Nijmegen, PO Box 9011, 6500 GM, Netherlands.
Frank H J van den HoogenDepartment of Rheumatology, Sint Maartenskliniek, Nijmegen, PO Box 9011, 6500 GM, Netherlands Department of Rheumatology, Radboud University Medical Centre (UMC), Nijmegen.
Wietske KievitDepartment for Health Evidence, Radboud UMC, Nijmegen.
Ronald F van VollenhovenClinTRID, Karolinska Institute, Stockholm, Sweden.
Johannes W J BijlsmaDepartment of Rheumatology and Immunology, Utrecht UMC, Utrecht, Netherlands.
Bart J F van den BemtDepartment of Pharmacy, Sint Maartenskliniek Department of Pharmacy, Radboud UMC, Nijmegen.
Alfons A den BroederDepartment of Rheumatology, Sint Maartenskliniek, Nijmegen, PO Box 9011, 6500 GM, Netherlands.
Sint Maartenskliniek · NLKarolinska Institutet · SEUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate whether a disease activity guided strategy of dose reduction of two tumour necrosis factor (TNF) inhibitors, adalimumab or etanercept, is non-inferior in maintaining disease control in patients with rheumatoid arthritis compared with usual care.

designRandomised controlled, open label, non-inferiority strategy trial.

settingTwo rheumatology outpatient clinics in the Netherlands, from December 2011 to May 2014.

participants180 patients with rheumatoid arthritis and low disease activity using adalimumab or etanercept; 121 allocated to the dose reduction strategy, 59 to usual care.

interventionsDisease activity guided dose reduction (advice to stepwise increase the injection interval every three months, until flare of disease activity or discontinuation) or usual care (no dose reduction advice). Flare was defined as increase in DAS28-CRP (a composite score measuring disease activity) greater than 1.2, or increase greater than 0.6 and current score of at least 3.2. In the case of flare, TNF inhibitor use was restarted or escalated.

main outcome measuresDifference in proportions of patients with major flare (DAS28-CRP based flare longer than three months) between the two groups at 18 months, compared against a non-inferiority margin of 20%. Secondary outcomes included TNF inhibitor use at study end, functioning, quality of life, radiographic progression, and adverse events.

resultsDose reduction of adalimumab or etanercept was non-inferior to usual care (proportion of patients with major flare at 18 months, 12% v 10%; difference 2%, 95% confidence interval -12% to 12%). In the dose reduction group, TNF inhibitor use could successfully be stopped in 20% (95% confidence interval 13% to 28%), the injection interval successfully increased in 43% (34% to 53%), but no dose reduction was possible in 37% (28% to 46%). Functional status, quality of life, relevant radiographic progression, and adverse events did not differ between the groups, although short lived flares (73% v 27%) and minimal radiographic progression (32% v 15%) were more frequent in dose reduction than usual care.

conclusionsA disease activity guided, dose reduction strategy of adalimumab or etanercept to treat rheumatoid arthritis is non-inferior to usual care with regard to major flaring, while resulting in the successful dose reduction or stopping in two thirds of patients.Trial registration Dutch trial register (www.trialregister.nl), NTR 3216.

Indexed as

AdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidCost-Benefit AnalysisDisease ProgressionDrug Administration ScheduleEtanerceptFemaleFollow-Up StudiesFootHandHumansImmunoglobulin GMaleNetherlandsAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic AgentsEtanerceptImmunoglobulin GReceptors, Tumor Necrosis FactorTumor Necrosis Factor-alpha

Identifiers

PMID25858265
PMCPMC4391970
OpenAlexW2019159305

What OpenQuestion holds

Textmetadata
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.