Evidence map›Paper›PMID 27497257›Full record

ReviewLupus2016

A critical review of clinical trials in systemic lupus erythematosus.

M A Mahieu, V Strand, L S Simon, P E Lipsky, R Ramsey-Goldman

Abstract readReview
In one paragraph

Review in Lupus, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
7.8field-weighted citation impact, top 2% 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

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Review
  9. Fibrosis in Immune-Mediated and Autoimmune Disorders.Journal of clinical medicine · 2025
    Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Genetic in situ engineering of myeloid regulatory cells controls inflammation in autoimmunity.Journal of controlled release : official journal of the Controlled Release Society · 2021
    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

5 authors at 3 institutions in 1 country.

M A MahieuDepartment of Medicine, Division of Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, USA mary-mahieu@fsm.northwestern.edu.
V StrandDivision of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, USA.
L S SimonSDG LLC, Cambridge, USA.
P E LipskyAMPEL BioSolutions, Charlottesville, USA.
R Ramsey-GoldmanDepartment of Medicine, Division of Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, USA.
Northwestern University · USAmpel BioSolutions (United States) · USStanford University · US

Funding

POSTDOCTORAL RHEUMATOLOGY TRAININGT32AR007611 · NIAMS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI PERLMAN, HARRIS R · 2001 to 2022
$4.4M
NIAMS NIH HHS T32 AR007611
6 · The paper itself

Abstract

One challenge in caring for patients with systemic lupus erythematosus (SLE) is a paucity of approved therapeutics for treatment of the diverse disease manifestations. In the last 60 years, only one drug, belimumab, has been approved for SLE treatment. Critical evaluation of investigator initiated and pharma-sponsored randomized controlled trials (RCTs) highlights barriers to successful drug development in SLE, including disease heterogeneity, inadequate trial size or duration, insufficient dose finding before initiation of large trials, handling of background medications, and choice of primary endpoint. Herein we examine lessons learned from landmark SLE RCTs and subsequent advances in trial design, as well as discuss efforts to address limitations in current SLE outcome measures that will improve detection of true therapeutic responses in future RCTs.

Indexed as

Clinical Trials, Phase III as TopicDrug ApprovalDrug IndustryHumansImmunosuppressive AgentsLupus Erythematosus, SystemicRandomized Controlled Trials as TopicTreatment OutcomeUnited StatesUnited States Food and Drug AdministrationImmunosuppressive Agentsclinical trialsoutcome measuresSystemic lupus erythematosus

Identifiers

PMID27497257
PMCPMC4978143
OpenAlexW2480131152

What OpenQuestion holds

Textmetadata
LicenceTDM
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.