Evidence map›Paper›PMID 24670196›Full record

Trial reportArthritis research & therapy2014

Rituximab in patients with rheumatoid arthritis in routine practice (GERINIS): six-year results from a prospective, multicentre, non-interventional study in 2,484 patients.

Joerg Wendler, Gerd R Burmester, Helmut Sörensen, Andreas Krause, Constanze Richter, Hans-Peter Tony, Andrea Rubbert-Roth, Peter Bartz-Bazzanella, Siegfried Wassenberg, Iris Haug-Rost and 1 more

Open access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Arthritis research & therapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
4.6field-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

25 citing papers in PubMed, 56 citations in OpenAlex.

  1. Trial
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  10. Adverse drug reactions of Rituximab in patients suffering from autoimmune neurological diseases.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2022
    Observational
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  12. Review
  13. Observational
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  19. Observational
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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

11 authors at 7 institutions in 1 country.

Joerg Wendler
Gerd R Burmester
Helmut Sörensen
Andreas Krause
Constanze Richter
Hans-Peter Tony
Andrea Rubbert-Roth
Peter Bartz-Bazzanella
Siegfried Wassenberg
Iris Haug-Rost
Thomas Dörner
Fachklinik 360° · DEGerman Rheumatism Research Centre · DEHumboldt-Universität zu Berlin · DEImmanuel Krankenhaus · DEOlgahospital · DERoche Pharma AG (Germany) · DEUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of this study was to evaluate the safety and efficacy of rituximab (RTX) in a large cohort of patients with rheumatoid arthritis in routine care, and to monitor changes in daily practice since the introduction of RTX therapy.

methodsThis was a multicentre, prospective, non-interventional study conducted under routine practice conditions in Germany. Efficacy was evaluated using Disease Activity Score in 28 joints (DAS28) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Safety was assessed by recording adverse drug reactions (ADRs). Physician and patient global efficacy and tolerability assessments were also evaluated.

resultsOverall, 2,484 patients (76.7% female, mean age 56.4 years, mean disease duration 11.7 years) received RTX treatment (22.7% monotherapy). The total observation period was approximately six-years (median follow-up 14.7 months). RTX treatment led to improvements in DAS28 and HAQ-DI that were sustained over multiple courses. DAS28 improvements positively correlated with higher rheumatoid factor levels up to 50 IU/ml. Response and tolerability were rated good/very good by the majority of physicians and patients. Mean treatment intervals were 10.5 and 6.8 months for the first and last 400 enrolled patients, respectively. Infections were the most frequently reported ADRs (9.1%; 11.39/100 patient-years); approximately 1% of patients per course discontinued therapy due to ADRs.

conclusionsProlonged RTX treatment in routine care is associated with good efficacy and tolerability, as measured by conventional parameters and by physicians' and patients' global assessments. Rheumatoid factor status served as a distinct and quantitative biomarker of RTX responsiveness. With growing experience, physicians repeated treatments earlier in patients with less severe disease activity.

Indexed as

AdultAgedAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsArthritis, RheumatoidFemaleHumansMaleMiddle AgedProspective StudiesRituximabTreatment OutcomeAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsRituximab

Identifiers

PMID24670196
PMCPMC4060207
OpenAlexW2010937399

What OpenQuestion holds

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LicenceCC BY
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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.