Evidence map›Paper›PMID 23566295›Full record

ReviewArthritis research & therapy2013

B-cell depletion in SLE: clinical and trial experience with rituximab and ocrelizumab and implications for study design.

Venkat Reddy, David Jayne, David Close, David Isenberg

Open access · goldAbstract readReview
In one paragraph

Review in Arthritis research & therapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 3 pooled it
16.6field-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

51 citing papers in PubMed, 3 syntheses or guidelines pooled it, 136 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. InterferonFrontiers in immunology · 2020
    Trial
  5. Trial
  6. Trial
  7. Review
  8. Anti-CD20 therapy in lupus nephritis: A revisit.Rheumatology and immunology research · 2025
    Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Nanomaterials for antigen-specific immune tolerance therapy.Drug delivery and translational research · 2023
    Review
  20. Article
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

4 authors at 3 institutions in 1 country.

Venkat ReddyCentre for Rheumatology, The Rayne Building, 4th Floor, Room 424, 5 University Street, London WC1E 6JF, UK. v.reddy@ucl.ac.uk
David Jayne
David Close
David Isenberg
British Society for Rheumatology · GBCambridge University Hospitals NHS Foundation Trust · GBUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

B cells are believed to be central to the disease process in systemic lupus erythematosus (SLE), making them a target for new therapeutic intervention. In recent years there have been many publications regarding the experience in SLE of B-cell depletion utilising rituximab, an anti-CD20 mAb that temporarily depletes B cells,reporting promising results in uncontrolled open studies and in routine clinical use. However, the two large randomised controlled trials in extra-renal lupus (EXPLORER study) and lupus nephritis (LUNAR study) failed to achieve their primary endpoints. Based on the clinical experience with rituximab this failure was somewhat unexpected and raised a number of questions and concerns, not only into the true level of benefit of B-cell depletion in a broad population but also how to test the true level of effectiveness of an investigational agent as we seek to improve the design of therapeutic trials in SLE. A better understanding of what went wrong in these trials is essential to elucidate the underlying reasons for the disparate observations noted in open studies and controlled trials. In this review, we focus on various factors that may affect the ability to accurately and confidently establish the level of treatment effect of the investigational agent, in this case rituximab, in the tw studies and explore hurdles faced in the randomised controlled trials investigating the efficacy of ocrelizumab, the humanised anti-CD20 mAb, in SLE. Further, based on the lessons learned from the clinical trials, we make suggestions that could be implemented in future clinical trial design to overcome the hurdles faced.

Indexed as

Antibodies, Monoclonal, HumanizedAntibodies, Monoclonal, Murine-DerivedB-LymphocytesDose-Response Relationship, DrugHumansImmunologic FactorsLupus Erythematosus, SystemicRandomized Controlled Trials as TopicRituximabTreatment OutcomeAntibodies, Monoclonal, HumanizedAntibodies, Monoclonal, Murine-DerivedImmunologic FactorsocrelizumabRituximab

Identifiers

PMID23566295
PMCPMC3624107
OpenAlexW2142659101

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.