Evidence map›Paper›PMID 20223838›Full record

Trial reportAnnals of the rheumatic diseases2010

The Stop Arthritis Very Early (SAVE) trial, an international multicentre, randomised, double-blind, placebo-controlled trial on glucocorticoids in very early arthritis.

Klaus P Machold, Robert Landewé, Josef S Smolen, Tanja A Stamm, Désirée M van der Heijde, Kirsten N Verpoort, Kerstin Brickmann, Janitzia Vázquez-Mellado, Dimitri E Karateev, Ferdinand C Breedveld and 2 more

Erratum issuedAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
10.0field-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

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 135 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  16. Pre-RA: Can early diagnosis lead to prevention?Best practice & research. Clinical rheumatology · 2022
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 5 countries.

Klaus P MacholdMedical University of Vienna, Vienna A-1090, Austria. klaus.machold@meduniwien.ac.at
Robert Landewé
Josef S Smolen
Tanja A Stamm
Désirée M van der Heijde
Kirsten N Verpoort
Kerstin Brickmann
Janitzia Vázquez-Mellado
Dimitri E Karateev
Ferdinand C Breedveld
Paul Emery
Thomas W J Huizinga
Leiden University Medical Center · NLMedical University of Vienna · ATInstitute of Rheumatology · CZMaastricht University · NLMedical University of Graz · ATNIHR Leeds Musculoskeletal Biomedical Research Unit · GBUniversidad Nacional Autónoma de México · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlucocorticoids (GCs) are often used as early arthritis treatment and it has been suggested that they induce remission or at least delay the development of rheumatoid arthritis (RA) and the need to start disease-modifying antirheumatic drugs (DMARDs).

objectiveTo test the effect of GCs on patients with very early arthritis (symptom duration of <16 weeks) in a randomised controlled trial.

methodsPatients received a single intramuscular injection of 120 mg methylprednisolone or placebo (PL) and were followed up for 52 weeks. Primary end point was drug-free clinical remission, both at weeks 12 and 52. Among secondary outcomes were fulfillment of remission criteria at weeks 2, 12 or 52, time course of 'core set variables' and proportion of patients starting DMARDs.

results17.0% of all analysed subjects (65/383) achieved persistent remission: 17.8% (33/185) of the PL group, 16.2% (32/198) of the patients receiving methylprednisolone (OR=1.13, 95% CI 0.66 to 1.92, p=0.6847). Analyses of secondary end points showed significant clinical benefits of the GC only at week 2. These differences subsequently disappeared. DMARDs were started in 162 patients: 50.3% methylprednisolone and 56.7% PL patients had to start DMARD treatment (OR=0.78, 95% CI 0.49 to 1.22, p=0.30). Significantly more patients with polyarthritis than with oligoarthritis received DMARDs (OR=2.84, 95% CI 1.75 to 4.60, p<0.0001).

conclusionsNeither remission nor development of RA is delayed by GC treatment. Remission is rare in the first year of very early arthritis, occurring in <20% of the patients. Also, the need to start DMARDs was not influenced by GC treatment.

Indexed as

AdultAgedAged, 80 and overAnti-Inflammatory AgentsAntirheumatic AgentsArthritisDrug Therapy, CombinationEpidemiologic MethodsFemaleGlucocorticoidsHumansMaleMethylprednisoloneMiddle AgedRemission InductionYoung AdultAnti-Inflammatory AgentsAntirheumatic AgentsGlucocorticoidsMethylprednisolone

Identifiers

PMID20223838
OpenAlexW2058720282

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.