Evidence map›Paper›PMID 41045868›Full record

Trial reportSeminars in arthritis and rheumatism2025

Discontinuation versus continuation of maintenance treatment with tumor necrosis factor inhibitors in patients with rheumatoid arthritis with low disease activity or remission: A randomized double-blind placebo-controlled trial.

Michael M Ward, Arthur Weinstein, Paloma Alejandro-Silva, Alan K Matsumoto, Rukmini Konatalapalli, Neil Stahl, Gail S Kerr, Jamal Mikdashi, Phillip Kempf, Nehal R Shah and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Seminars in arthritis and rheumatism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01793519 (Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT01793519 phase4unknown statusnot on this map

Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical Trial

TypeinterventionalSponsorGeorgetown UniversityRan2013 to 2024Enrolled290ConditionsRheumatoid ArthritisArmsEtanercept, Infliximab, Adalimumab, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Michael M WardIntramural Research Program, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda MD, current address: Verier Outcomes Research, LLC, Rockville MD, USA.
Arthur WeinsteinDepartment of Medicine, Medstar Washington Hospital Center, Washington DC, current address: Department of Medicine, Loma Linda University, Loma Linda, CA, USA.
Paloma Alejandro-SilvaDivision of Rheumatology, Medstar Washington Hospital Center and Medstar Georgetown Medical Center, Washington DC, current address: Mindful Rheumatix and Medical Research Group, San Juan, PR.
Alan K MatsumotoArthritis and Rheumatism Associates, Wheaton MD, USA.
Rukmini KonatalapalliArthritis and Pain Associates of PG County, Greenbelt MD, USA.
Neil StahlArthritis and Rheumatic Disease Associates, Burke, VA, USA.
Gail S KerrWashington DC Veterans Affairs Medical Center, Washington DC, Georgetown and Howard University Hospitals, Uniformed Services University of the Health Sciences, Washington, DC, USA.
Jamal MikdashiDepartment of Medicine, University of Maryland Medical Center, Baltimore MD, USA.
Phillip KempfArthritis Clinic of Northern Virginia, Arlington VA, USA.
Nehal R ShahDepartment of Internal Medicine, Virginia Commonwealth University, Richmond VA, USA.
Stamatina DanielidesDepartment of Internal Medicine, Virginia Commonwealth University, Richmond VA, current address: Inova Hospital, Fairfax, VA, USA.
Mohsen GhafouriArthritis and Osteoporosis Center of Northern Virginia, Manassas VA, USA.
Thomas P OlenginskiGeisinger Health System, Danville, PA, USA.
Alice FikeIntramural Research Program, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda MD, USA.
Denitza Balyozova-DinkovMedstar Washington Hospital Center, Washington, DC, USA.
Ralf ThieleDepartment of Medicine, University of Rochester School of Medicine and Dentistry, Rochester NY, USA.
Lawrence YaoRadiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda MD, USA.
Subrata PaulResearch Technologies Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Florina ConstantinescuDepartment of Medicine, Georgetown University and Medstar Washington Hospital Center, Washington, DC, USA. Electronic address: Florina.Constantinescu@MedStar.net.

Funding

Outcomes in Rheumatic DiseasesZIAAR041153 · NIAMS · NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES · PI WARD, MICHAEL · 2009 to 2020
$12.6M
Outcomes in Rheumatic DiseasesZ01AR041153 · NIAMS · NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES · PI WARD, MICHAEL · 2005 to 2008
$1.6M
Intramural NIH HHS Z01 AR041153Intramural NIH HHS ZIA AR041153
6 · The paper itself

Abstract

objectivePatients with rheumatoid arthritis (RA) in sustained remission/low disease activity with tumor necrosis factor inhibitor (TNFi) treatment may be candidates for treatment de-escalation. We compared the frequency of relapses and flares of RA after TNFi discontinuation with TNFi continuation among such patients. We also investigated predictors of relapse.

methodsThis randomized, double-blind, placebo controlled noninferiority trial enrolled adults with RA who were treated with either adalimumab, etanercept, or infliximab, and who had a Disease Activity Score 28-C-reactive protein (DAS-CRP) < 2.6 for at least six months. Patients were randomly assigned 2:1 to either placebo injections/infusions (i.e. discontinuation) or active TNFi. Patients, investigators, and study staff were masked to treatment assignment. The primary endpoint was relapse over 48 weeks, defined as either DAS29-CRP ≥ 2.6 or treatment escalation. Secondary endpoints included flare, defined as an increase in DAS28-CRP ≥ 1.2 from baseline.

resultsThe study was stopped early based on an interim analysis that rejected noninferiority. At study interruption, 102 patients (69 placebo; 33 active TNFi) were randomized. Relapses occurred in 59.4 % of the placebo group and 18.1 % of the active TNFi group (hazard ratio 4.88; 95 % confidence interval 2.05, 11.61). Flares occurred in 43.5 % and 15.1 % of these groups, respectively. Over 48 weeks, successful discontinuation was achieved in 55 % of patients who discontinued adalimumab and 26 % of patients who discontinued etanercept.

conclusionDiscontinuation of maintenance TNFi resulted in higher rates of relapse of RA than continuation.

trial registrationClinicaltrials.gov NCT01793519.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidTumor Necrosis Factor-alphaAdalimumabAdultAgedDouble-Blind MethodEtanerceptFemaleHumansInfliximabMaleMiddle AgedRecurrenceRemission InductionSeverity of Illness IndexAdalimumabAntirheumatic AgentsEtanerceptInfliximabTumor Necrosis Factor-alphaRemissionRheumatoid arthritisTumor necrosis factor inhibitors

Identifiers

PMID41045868
PMCPMC13421812

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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.