Evidence map›Paper›PMID 25994819›Full record

Trial reportArthritis research & therapy2015

Existing joint erosions increase the risk of joint space narrowing independently of clinical synovitis in patients with early rheumatoid arthritis.

Robert Landewé, Josef S Smolen, Stefan Florentinus, Su Chen, Benoît Guérette, Désirée van der Heijde

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00195663 (A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis), which is not on this map. Cited by 8 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 5 pooled it
2.7field-weighted citation impact, top 11% 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.

NCT00195663 phase3completednot on this map

A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER).

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2000 to 2012Enrolled799ConditionsEarly Rheumatoid ArthritisArmsAdalimumab, Methotrexate, Adalimumab placebo, Methotrexate placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 5 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
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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

6 authors at 4 institutions in 4 countries.

Robert LandewéAmsterdam Rheumatology Center, Amsterdam, The Netherlands and Atrium Medical Center, Heerlen, The Netherlands. Landewe@rlandewe.nl.
Josef S SmolenMedical University of Vienna, Vienna, Austria. josef.smolen@wienkav.at.
Stefan FlorentinusAbbVie, Rungis, France. stefan.florentinus@abbvie.com.
Su ChenAbbVie Inc., North Chicago, IL, USA. su.chen@abbvie.com.
Benoît GuéretteAbbVie Inc., North Chicago, IL, USA. benoit.guerette@abbvie.com.
Désirée van der HeijdeLeiden University Medical Center, Leiden, The Netherlands. mail@dvanderheijde.nl.
AbbVie (United States) · USAtrium Medisch Centrum Parkstad · NLLeiden University Medical Center · NLMedical University of Vienna · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionClinical synovitis is often associated with damage to bone and cartilage. Previous data have suggested that joint erosions (JE) are more prevalent than joint space narrowing (JSN) and that the two processes are partly independent of each other. The objective of this study was to evaluate whether the presence of JE in an individual joint can lead to development of JSN and if existing JSN leads to new onset of JE, in the absence of synovitis.

methodsThe Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER) enrolled early rheumatoid arthritis (RA) patients who were randomized to one of three treatments: methotrexate (MTX), adalimumab (ADA), or ADA + MTX. All evaluable joints with JE and JSN measures at 26 and 52 weeks and synovitis assessments from week 26 to 52 were included. Synovitis was assessed every 2-8 weeks by swollen joint counts between weeks 26 and 52. Radiographs were taken at week 26 and 52. Two readers, blinded to time and sequence, scored 14 bilateral joints individually for JE and JSN. Multivariate logistic modeling was used to characterize the dependence of JE/JSN onset at 52 weeks. Analyses were performed based on treatment arm and were also performed within individual joints.

resultsJE and swelling were independently and comparably associated with onset of JSN at week 52. Assessment by individual joints indicated that existing JE, independent of swelling, was significantly associated with JSN onset in higher proportions of metatarsophalangeal (MTP; 7/10) than proximal interphalangeal (PIP; 1/8) or metacarpophalangeal (MCP; 1/10) joints. Treatment with ADA + MTX prevents JE/JSN progression independently of its ability to suppress synovitis and limits JE/JSN onset and progression in joints with existing damage.

conclusionsExisting JE predisposes individual joints to development of JSN independently of synovitis in the same joint. Weight-bearing MTP joints with JE may be at increased risk for JSN when compared with MCPs and PIPs.

trial registrationClinicaltrials.gov NCT00195663. Registered 13 September 2005.

Indexed as

AdalimumabAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedRadiographySynovitisAdalimumabAntirheumatic AgentsMethotrexate

Identifiers

PMID25994819
PMCPMC4440309
OpenAlexW2156725899

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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.