Evidence map›Paper›PMID 20496042›Full record

Trial reportClinical rheumatology2010

Leflunomide in the treatment of patients with early rheumatoid arthritis--results of a prospective non-interventional study.

Herbert Kellner, Klaus Bornholdt, Gert Hein

Abstract readClinical TrialMulticenter Study
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 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing 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.

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

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

  1. Pooled it
  2. Trial
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  13. Update on Treatment in Cardiac Sarcoidosis.Current treatment options in cardiovascular medicine · 2017
    Review
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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

3 authors.

Herbert KellnerDivision of Rheumatology, Center for Inflammatory Joint Diseases, KH Neuwittelsbach, Romanstr. 9, 80639 Munich, Germany. hk@prof-dr-kellner.de
Klaus Bornholdt
Gert Hein

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Leflunomide is effective and well tolerated in the treatment of rheumatoid arthritis (RA), however, data on its use in early RA are scarce. This study seeks to evaluate effectiveness and safety of leflunomide in the treatment of early RA in daily practice. This prospective, open-label, non-interventional, multi-center study was carried out over 24 weeks including adults with early RA (< or =1 year since diagnosis). Leflunomide treatment was according to label instructions. Three hundred thirty-four patients were included. Disease activity score in 28 joints (DAS28) response (reduction in DAS28 of >1.2 or reduction of >0.6 and a DAS28 of < or =5.1) was 71.9% at week 12 and 84.6% at week 24. 25.0% of patients achieved clinical remission (DAS28 < or = 2.6). Most frequently reported adverse drug reactions (ADR) were diarrhea (3.0%), nausea (2.4%), hypertension (1.8%), and headache (1.5%). Serious ADR were reported in four patients (1.2%). Leflunomide showed the effectiveness which was to be expected from controlled studies without revealing any new or hitherto unknown side effects. Onset of action was quick and significant improvement of disease was seen after 12 weeks of therapy and at even higher rates after 24 weeks irrespective of the use of a loading dose. Interestingly, the DAS28-remission rate achieved was similar to the rate seen with methotrexate or biologic therapy in other studies.

Indexed as

AdultAgedAnti-Inflammatory Agents, Non-SteroidalArthritis, RheumatoidBlood SedimentationDiarrheaFemaleHeadacheHumansHypertensionIncidenceIsoxazolesLeflunomideMaleMiddle AgedNauseaAnti-Inflammatory Agents, Non-SteroidalIsoxazolesLeflunomide

Identifiers

PMID20496042
PMCPMC2895904

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.