Evidence map›Paper›PMID 16677395›Full record

Trial reportArthritis research & therapy2006

Clinical and immunological effects of Rituximab in patients with lupus nephritis refractory to conventional therapy: a pilot study.

Mónica Vigna-Perez, Berenice Hernández-Castro, Octavio Paredes-Saharopulos, Diana Portales-Pérez, Lourdes Baranda, Carlos Abud-Mendoza, Roberto González-Amaro

Open access · goldAbstract readClinical TrialComparative Study
In one paragraph

Trial report in Arthritis research & therapy, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 82 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 2 pooled it
21.7field-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

82 citing papers in PubMed, 2 syntheses or guidelines pooled it, 305 citations in OpenAlex.

  1. Pooled it
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  7. Article
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  14. Off-Label Uses of Rituximab in Dermatology.Current dermatology reports · 2022
    Review
  15. Article
  16. Article
  17. Rituximab Dosing in Glomerular Diseases: A Scoping Review.Canadian journal of kidney health and disease · 2022
    Article
  18. Article
  19. Article
  20. Article

22 more citing papers are in PubMed but not listed here.

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 2 institutions in 1 country.

Mónica Vigna-PerezDepartamento de Inmunología, Facultad de Medicina, UASLP, San Luis Potosí, SLP, México.
Berenice Hernández-Castro
Octavio Paredes-Saharopulos
Diana Portales-Pérez
Lourdes Baranda
Carlos Abud-Mendoza
Roberto González-Amaro
Autonomous University of San Luis Potosí · MXHospital Central Dr. Ignacio Morones Prieto · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We studied the clinical and immunological effects of Rituximab (anti-CD20) therapy in patients with lupus nephritis. In an open clinical trial, 22 patients with active systemic lupus erythematosis and renal involvement (mainly class III and IV according to the WHO classification) that was refractory to conventional therapy were studied. In all these patients, Rituximab (0.5 to 1.0 g at days 1 and 15) was added to the immunosuppressive therapy and its therapeutic effect was evaluated. In addition, the levels and function of regulatory T lymphocytes and the apoptosis of immune cells were assessed. We found a significant reduction in disease activity (p < 0.05, MEX-SLEDAI index), and proteinuria (p < 0.05) at days 60 and 90 of Rituximab therapy. Although most patients showed improvement in creatinine clearance and erythrocyturia, no significant changes in these parameters were detected. In most patients (20/22), B cell depletion was observed, but no clear-cut effect of Rituximab on complement levels or auto-antibody titers was detected (p > 0.05 in all cases). One patient died at day 70 with invasive histoplasmosis. No important adverse effects of Rituximab therapy were registered in other patients. A significant enhancement in the levels of different CD4+ regulatory cells (TREG, Th3, Tr1), but not CD8+ Ts lymphocytes, was observed at day 30. This increase was sustained for TREG cells at day 90, and accompanied by an improvement in their regulatory function. In addition, we observed an unexpected increase in the apoptosis of T cells at day 30. Interestingly, the enhancement in the suppressive function of TREG cells was not observed in the two patients that showed the poorest clinical response to Rituximab. We conclude that the data obtained in this open clinical trial suggest that Rituximab is a promising candidate for randomized controlled trials in patients with lupus nephritis refractory to the conventional immunosuppressive therapy. The effects of Rituximab on regulatory cells and apoptosis of T lymphocytes are interesting and its possible role in the putative effect of this biological agent in systemic lupus erythematosis deserves additional studies.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsApoptosisCD4-Positive T-LymphocytesDrug Therapy, CombinationFemaleHumansImmunologic FactorsLupus NephritisLymphocyte ActivationMaleMethotrexateMiddle AgedPilot ProjectsAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsImmunologic FactorsMethotrexateRituximab

Identifiers

PMID16677395
PMCPMC1526618
OpenAlexW1938487222

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.