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Proposal 1108

Title of the Proposed Research

Correlation between SF-36 PCS and MCS scores and SELENA SLEDAI activity score in SLE: a meta-analysis.

Lead Researcher

Chaigne Benjamin, MD

Affiliation

University Hospital and School of Medicine
Geneva, Switzerland

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

None

Lay Summary

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that mainly affects childbearing-aged women. Although its pathogenesis is not fully understood, it is a multifactorial disease with alteration of the immune system, genetic susceptibility and environmental factors. Clinical presentation is diverse and it may include skin, renal, nervous system, haematological system, or joint involvements. As a result SLE impairs health related quality of life (HRQOL) of patients and new treatments aim at improving HRQOL and decreasing disease activity.

Several studies have used the Medical Outcome Study 36-Item Short Form Health Survey (SF-36) to investigate HRQOL in lupus patients showing that it is a useful and reliable tool to assess HRQOL. It has been used to assess treatment efficiency or to predict disease prognosis. However, conflicting results exist regarding the influence of disease activity on HRQOL and the question of the presence or the absence of correlation between disease activity and SF-36 remains unsolved.

The aim of this study is to find out a correlation between SF-36 PCS and MCS scores and SELENA SLEDAI score.

A systematic search on PubMed have identified 13 relevant studies (which include the two BLISS trials) that have used SF-36 to assess quality of life and SELENA SLEDAI to assess disease activity. We propose to perform a meta-analysis with these existing studies to report the correlation between these scores. Our study will directly improve patient care and SLE research as it will allow practitioners in charge of a patient with SLE to know if SELENA SLEDAI activity score is useful to treat to targeted HRQOL.

Findings will be interpreted by the main leaders of the study assisted by the director of the Division of Clinical Epidemiology of Geneva University Hospital and School of Medicine.

Findings will be then communicated to public during national (France and Switzerland) and international conferences (ACR/EULAR) and through an article submitted in a peer-reviewed journal.

Study Data Provided

Study HGS1006-C1056: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)
Study HGS1006-C1057: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation