Evidence map›Paper›PMID 20082236›Full record

Trial reportClinical rheumatology2010

Comparison of combination therapies in the treatment of rheumatoid arthritis: leflunomide-anti-TNF-alpha versus methotrexate-anti-TNF-alpha.

Renato De Stefano, Elena Frati, Fernando Nargi, Caterina Baldi, Luana Menza, Mohammed Hammoud, Mauro Galeazzi

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 5% 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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Etanercept for the treatment of rheumatoid arthritis.The Cochrane database of systematic reviews · 2013
    Pooled it
  3. Trial
  4. Trial
  5. A randomized, double-blinded, placebo-controlled pilot study of probiotics in active rheumatoid arthritis.Medical science monitor : international medical journal of experimental and clinical research · 2011
    Trial
  6. Article
  7. Observational
  8. Review
  9. Review
  10. Article
  11. Optimal dose of etanercept in the treatment of rheumatoid arthritis.Open access rheumatology : research and reviews · 2014
    Review
  12. Review
  13. Intracellular Signaling Pathways in Rheumatoid Arthritis.Journal of clinical & cellular immunology · 2013
    Article
  14. Review
  15. Article
  16. Article
  17. 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

7 authors at 1 institution in 1 country.

Renato De StefanoRheumatology Unit, Azienda Ospedaliera Universitaria Senese, viale Bracci, 1, 53100, Siena, Italy. donamara2006@libero.it
Elena Frati
Fernando Nargi
Caterina Baldi
Luana Menza
Mohammed Hammoud
Mauro Galeazzi
Azienda Ospedaliera Universitaria Senese · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To compare the efficacy and safety of leflunomide (LEF)-anti-TNF-alpha combination therapy to methotrexate (MTX)-anti-TNF-alpha combination therapy in a group of patients with active rheumatoid arthritis (RA). We have recruited 120 patients with RA with a high disease activity despite being treated with MTX (15 mg/week) or LEF (20 mg/die) for 3 months, without side effects. In each of these patients, therapy with either MTX or LEF was continued and randomly combined with an anti-TNF-alpha drug: etanercept, infliximab, or adalimumab. Patients were assessed at study entry and at 4, 12, and at 24 weeks. The efficacy endpoints included variations in the DAS28-ESR and the ACR20, ACR50, and ACR70 responses. At each visit, any side-effect was recorded. There were no statistically significant differences in the DAS28 variations and in the ACR responses between the two groups or among the six subgroups. The number of discontinuation due to the appearance of serious side effects was higher, but not statistically significant, in the LEF-anti-TNF-alpha group than in the MTX-anti-TNF-alpha group. Other adverse events that did not necessitate the discontinuation of therapy occurred much more frequently in patients treated with MTX than in those treated with LEF. Anti-TNF-alpha drugs can be used in combination not only with MTX, but also with LEF, with the same probability of achieving significant clinical improvement in RA patients and without a significantly greater risk of serious adverse events. In contrast, it seems that combination therapy with LEF-anti-TNF-alpha is more readily tolerated than combination therapy with MTX-anti-TNF-alpha.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidAutoimmunityDisease ProgressionDrug Therapy, CombinationFemaleHumansIsoxazolesLeflunomideMaleMethotrexateMiddle AgedRiskTime FactorsAntirheumatic AgentsIsoxazolesLeflunomideMethotrexateTumor Necrosis Factor-alpha

Identifiers

PMID20082236
OpenAlexW2030855147

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.