Evidence map›Paper›PMID 41173511›Full record

Trial reportRMD open2025

Poor health-related quality of life despite Lupus Low Disease Activity State or Definitions of Remission in systemic lupus erythematosus (SLE) remission in patients with SLE: results from a clinical trial setting.

Ioannis Parodis, Julius Lindblom, Leonardo Palazzo, Alexander Tsoi, Nursen Cetrez, Henri Ala, Mandana Nikpour, Adrian Levitsky, Vibeke Strand

Abstract readClinical Trial, Phase III
In one paragraph

Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025
    Review
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

9 authors.

Ioannis ParodisDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden ioannis.parodis@ki.se.ORCID 0000-0002-4875-5395
Julius LindblomDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden.
Leonardo PalazzoDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden.
Alexander TsoiDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden.
Nursen CetrezDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden.
Henri AlaDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden.
Mandana Nikpour *University of Sydney School of Public Health, Sydney, New South Wales, Australia.
Adrian Levitsky *Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, and Center for Molecular Medicine (CMM), Stockholm, Sweden.
Vibeke Strand *Division of Immunology/Rheumatology, Stanford University School of Medicine, Stanford, California, USA.ORCID 0000-0003-4978-4072

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the prevalence of poor health-related quality of life (HRQoL) in patients with systemic lupus erythematosus (SLE) in Lupus Low Disease Activity State (LLDAS) or Definitions of Remission in SLE (DORIS) remission and sustained LLDAS or sustained DORIS remission, after a 52-week therapeutic intervention.

methodsWe analysed data from four phase III trials of belimumab in SLE (BLISS-52, BLISS-76, BLISS-SC, EMBRACE; n=2406). Sustained LLDAS/remission was defined as persistent LLDAS/remission for at least two visits, maintained through week 52. Poor HRQoL was defined as Short Form-36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores ≤the normative fifth percentile, Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scores <30 and responses of 'some/moderate problems' or 'extreme/major problems' in any of the five dimensions of the three-level version of EuroQol 5-Dimension (EQ-5D) health questionnaire.

resultsAt week 52, among patients in LLDAS, remission, sustained LLDAS and sustained remission, 15.7%, 13.6%, 14.3% and 9.0% reported poor SF-36 PCS, and 12.5%, 11.4%, 12.9% and 14.0% reported poor SF-36 MCS scores, respectively. The highest frequencies were reported in the physical functioning domain (24.0%-26.3%), while 18.5%-26.2% reported FACIT-F scores 30. Among EQ-5D dimensions, pain/discomfort yielded the greatest frequencies of poor HRQoL experience (27.9%-28.7%). While significant improvements were observed among patients achieving the treatment goals in all HRQoL outcomes over the 52-week study period, PCS scores remained below population norms.

conclusionsDespite LLDAS or DORIS remission, notable proportions of SLE patients report poor HRQoL, indicating that current therapeutic goal definitions do not fully capture patients' perspectives of health.

Indexed as

Lupus Erythematosus, SystemicQuality of LifeAdultAntibodies, Monoclonal, HumanizedFemaleHumansImmunosuppressive AgentsMaleMiddle AgedRemission InductionSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedbelimumabImmunosuppressive AgentsFatigueHealth-Related Quality Of LifePainSystemic Lupus Erythematosus

Identifiers

PMID41173511
PMCPMC12581079

What Socratic holds

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LicenceCC BY
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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 Socratic graph.