Evidence map›Paper›PMID 22550315›Full record

Trial reportAnnals of the rheumatic diseases2012

Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials.

Susan Manzi, Jorge Sánchez-Guerrero, Joan T Merrill, Richard Furie, Dafna Gladman, Sandra V Navarra, Ellen M Ginzler, David P D'Cruz, Andrea Doria, Simon Cooper and 5 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 155 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
155citing papers in PubMed, 7 pooled it
30.6field-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.

NCT04369495 withdrawnnot on this mapstarted 2021, after this paper: background citation

BAFF Levels After Cyclophosphamide and Mycophenolate Use in Patients With Systemic Lupus Erythematosus

TypeobservationalSponsorUniversidad de AntioquiaRan2021 to 2023Enrolled0ConditionsLupus NephritisArmsBAFF serum levels
NCT05659407 unknown statusnot on this mapstarted 2020, after this paper: background citation

The BAFF-var Polymorphism as a Biomarker of Response to B-depletive Treatment in Patients Affected by Systemic Lupus Erythematosus and Rheumatoid Arthritis: a Prospective Study

TypeobservationalSponsorUniversity of CagliariRan2020 to 2023Enrolled60ConditionsSystemic Lupus Erythematosus, Rheumatoid Arthritis, BLyS PolymorphismArmsBelimumab in SLE patients / Rituximab in RA patients
3 · Its place in the literature

Who cites it

155 citing papers in PubMed, 7 syntheses or guidelines pooled it, 397 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Guideline
  4. Belimumab for systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. Pooled it
  6. Drugs for discoid lupus erythematosus.The Cochrane database of systematic reviews · 2017
    Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Updates on the Evaluation of Lupus Arthritis.Rheumatology and therapy · 2026
    Review
  18. Article
  19. Article
  20. Article

95 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

15 authors at 11 institutions in 6 countries.

Susan ManziAllegheny Singer Research Institute, West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, Pennsylvania 15224, USA. smanzi@wpahs.org
Jorge Sánchez-Guerrero
Joan T Merrill
Richard Furie
Dafna Gladman
Sandra V Navarra
Ellen M Ginzler
David P D'Cruz
Andrea Doria
Simon Cooper
Z John Zhong
Douglas Hough
William Freimuth
Michelle A Petri
BLISS-52 and BLISS-76 Study Groups
Human Genome Sciences (United States) · USAllegheny-Singer Research Institute · USInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXJohns Hopkins Medicine · USNorthwell Health · USOklahoma Medical Research Foundation · USSt Thomas' Hospital · GBSUNY Downstate Health Sciences University · USToronto Western Hospital · CAUniversity of Padua · ITUniversity of Santo Tomas Hospital · PH

Funding

UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
NCATS NIH HHS UL1 TR000005NCRR NIH HHS UL1 RR024153
6 · The paper itself

Abstract

objectiveTo evaluate the effects of belimumab versus placebo, plus standard systemic lupus erythematosus (SLE) therapy, on organ domain-specific SLE disease activity.

methodsData obtained after 52 weeks of treatment from two phase III trials (BLISS-52 and BLISS-76) comparing belimumab 1 and 10 mg/kg versus placebo, plus standard therapy, in 1684 autoantibody-positive patients were analysed post hoc for changes in British Isles Lupus Assessment Group (BILAG) and Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) organ domain scores.

resultsAt baseline, the domains involved in the majority of patients were musculoskeletal and mucocutaneous by both BILAG and SELENA-SLEDAI, and immunological by SELENA-SLEDAI. At 52 weeks, significantly more patients treated with belimumab versus placebo had improvement in BILAG musculoskeletal and mucocutaneous domains (1 and 10 mg/kg), and in SELENA-SLEDAI mucocutaneous (10 mg/kg), musculoskeletal (1 mg/kg) and immunological (1 and 10 mg/kg) domains. Improvement was also observed in other organ systems with a low prevalence (≤16%) at baseline, including the SELENA-SLEDAI vasculitis and central nervous system domains. Significantly fewer patients treated with belimumab versus placebo had worsening in the BILAG haematological domain (1 mg/kg) and in the SELENA-SLEDAI immunological (10 mg/kg), haematological (10 mg/kg) and renal (1 mg/kg) domains.

conclusionsBelimumab treatment improved overall SLE disease activity in the most common musculoskeletal and mucocutaneous organ domains. Less worsening occurred in the haematological, immunological and renal domains.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedB-Cell Activating FactorDouble-Blind MethodFemaleHealth StatusHumansLupus Erythematosus, SystemicMaleSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedB-Cell Activating Factorbelimumab

Identifiers

PMID22550315
PMCPMC3465857
OpenAlexW2170524712

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.