Evidence map›Paper›PMID 26794605›Full record

Trial reportArthritis research & therapy2016

Two-year results of disease activity score (DAS)-remission-steered treatment strategies aiming at drug-free remission in early arthritis patients (the IMPROVED-study).

Lotte Heimans, Gülşah Akdemir, Kirsten V C Wevers-de Boer, Yvonne P Goekoop-Ruiterman, Esmeralda T Molenaar, Johannes H L M van Groenendael, Andreas J Peeters, Gerda M Steup-Beekman, Leroy R Lard, Peter B J de Sonnaville and 3 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 4% 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

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

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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

13 authors at 9 institutions in 2 countries.

Lotte HeimansDepartment of Rheumatology, Leiden University Medical Center, P.O. BOX 9600, Leiden, 2300 RC, The Netherlands. l.heimans@lumc.nl.
Gülşah AkdemirDepartment of Rheumatology, Leiden University Medical Center, P.O. BOX 9600, Leiden, 2300 RC, The Netherlands. g.akdemir@lumc.nl.
Kirsten V C Wevers-de BoerDepartment of Rheumatology, Leiden University Medical Center, P.O. BOX 9600, Leiden, 2300 RC, The Netherlands. kvcdeboer@hotmail.com.
Yvonne P Goekoop-RuitermanDepartment of Rheumatology, Haga Hospital, The Hague, The Netherlands. y.ruiterman@hagaziekenhuis.nl.
Esmeralda T MolenaarDepartment of Rheumatology, Groene Hart Hospital, Gouda, The Netherlands. esmeralda.molenaar@ghz.nl.
Johannes H L M van GroenendaelDepartment of Rheumatology, Franciscus Hospital, Roosendaal, The Netherlands. whisperwoods@cs.com.
Andreas J PeetersDepartment of Rheumatology, Reinier de Graaf Gasthuis, Delft, The Netherlands. peeters@rdgg.nl.
Gerda M Steup-BeekmanDepartment of Rheumatology, Bronovo Hospital, The Hague, The Netherlands. gmsteup@bronovo.nl.
Leroy R LardDepartment of Rheumatology, MCH Antoniushove, Leidschendam, The Netherlands. l.lard@mchaaglanden.nl.
Peter B J de SonnavilleDepartment of Rheumatology, Admiraal de Ruyter Ziekenhuis, Goes, The Netherlands. PdSonnaville@reumazorgzwn.nl.
Bernard A M GrilletDepartment of Rheumatology, Zorgsaam, Terneuzen, The Netherlands. BGrillet@reumazorgzwn.nl.
Tom W J HuizingaDepartment of Rheumatology, Leiden University Medical Center, P.O. BOX 9600, Leiden, 2300 RC, The Netherlands. t.w.j.huizinga@lumc.nl.
Cornelia F AllaartDepartment of Rheumatology, Leiden University Medical Center, P.O. BOX 9600, Leiden, 2300 RC, The Netherlands. c.f.allaart@lumc.nl.
Leiden University Medical Center · NLAdmiraal De Ruyter Ziekenhuis · NLBronovo Hospital · NLGGD Haaglanden · NLGroene Hart Ziekenhuis · NLHaga Hospital · NLReinier de Graaf Hospital · NLSint Franciscus Gasthuis · NLZoetis (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly suppression of disease activity in (rheumatoid) arthritis (RA) patients may result in drug-free remission and prevent damage. We assessed 2-year clinical and radiological outcomes of two disease activity score (DAS)-remission-steered treatment strategies in early arthritis patients.

methodsPatients (n = 610) with early RA or undifferentiated arthritis (UA) were treated with methotrexate (MTX) and tapered high dose of prednisone. Patients in early remission (44/53 joints DAS <1.6) after 4 months tapered and stopped medication. Patients who did not achieve early DAS-remission were randomized to either MTX plus hydroxychloroquine plus sulphasalazine plus low dose prednisone (arm 1) or to MTX + adalimumab (arm 2). At four-monthly intervals, medication was tapered and stopped if DAS was <1.6 but restarted, increased or switched if DAS was ≥1.6. Proportions of (drug-free) DAS-remission (DFR) after 2 years and Sharp-van der Heijde scores (SHS) were analyzed separately for the treatment strategies and patients with RA and UA.

resultsAfter 2 years, 301/610 (49 %) patients were in DAS-remission and 131/610 (21 %) in DFR. In the early remission group 241/387 patients (62 %) were in DAS-remission and 111/387 (29 %) DFR. In arm 1 22/83 (27 %) and in arm 2 24/78 (31 %) were in DAS-remission, and 6/83 (7 %) and 7/78 (9 %), respectively, were in DFR. RA and UA patients achieved DAS-remission in comparable percentages (RA: 234/479 (49 %), UA: 64/122 (52 %), p = 0.25). More UA patients achieved DFR (41/122 (34 %)) compared to RA patients (89/479 (19 %), p<0.001). Mean (SD) DAS over time was 1.74 (0.58) across all patients, and median (IQR) SHS progression was 0 (0-0).

conclusionsAfter 2 years remission-steered treatment in early RA and UA patients, DAS-remission and DFR percentages were relatively low. Patients who achieved early remission more often achieved (drug-free) remission after 2 years than patients who needed additional treatment steps in the randomization arms, and more UA than RA patients achieved DFR. Overall, disease activity and radiologic damage progression in all patients were well suppressed.

trial registrationhttp://www.controlled-trials.com/ISRCTN11916566 Registered 07/11/2006 and EudraCT number 2006-06186-16 Registered 16/07/2007.

Indexed as

Disease ProgressionSeverity of Illness IndexAdultAgedAntirheumatic AgentsArthritis, RheumatoidEarly DiagnosisFemaleHumansHydroxychloroquineMaleMethotrexateMiddle AgedRemission InductionSingle-Blind MethodSulfasalazineAntirheumatic AgentsHydroxychloroquineMethotrexateSulfasalazine

Identifiers

PMID26794605
PMCPMC4721018
OpenAlexW2275338833

What OpenQuestion holds

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Registered trials

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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.