This study is a secondary, pooled analysis of two completed phase 3 clinical trials:

(i) GSK-HGS1006-C1056 (BLISS-76): 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); and,

(ii) GSK-HGS1006-C1057 (BLISS-52): 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)

The study will assess the discriminant validity of a proposed measure of low disease activity (the Lupus Low Disease Activity State, LLDAS) in patients with SLE.

Systemic Lupus Erythematosus (SLE) is a multisystem autoimmune disease with an estimated incidence of 5-50 cases per 100,000 people. Despite advances in therapy, there is still significant mortality and morbidity associated with this disease. There have been no clearly defined treatment goals in SLE, hindering the development of treat to target approaches and evaluation of new therapies. Although remission is aimed for, it rarely occurs. A more achievable clinical state and treatment goal of low disease activity has been described recently and a preliminary single centre validation study has demonstrated its association with improved outcomes. This endpoint is termed Lupus Low Disease Activity State (LLDAS).

The proposed study will assess the discriminant validity of the proposed LLDAS criteria in a clinical trial dataset. The objective of the research is to validate the Lupus Low Disease Activity State (LLDAS) tool as a study endpoint in SLE. The data available from the belimumab BLISS trials will be used to evaluate the LLDAS score.

The outcome of these studies will be validation of the LLDAS instrument in a clinical trial dataset, for the first time. This will allow future studies to consider incorporating LLDAS attainment as a trial endpoint, for example allowing comparison of frequency of achieving LLDAS to discriminate between treatments.

The findings will be interpreted using statistical methods and will be published / presented to the public and to peers via peer-reviewed publications, conference presentations, and where relevant the lay media.

Key Inclusion Criteria:

• Clinical diagnosis of SLE by ACR criteria.
• Active SLE disease.
• Autoantibody-positive.
• On stable SLE treatment regimen.

Key Exclusion Criteria:

• Pregnant or nursing
• Have received treatment with any B cell targeted therapy.
• Have received treatment with a biological investigational agent in the past year.
• Have received IV cyclophosphamide within 180 days of Day 0.
• Have severe lupus kidney disease.
• Have active central nervous system (CNS) lupus.
• Have required management of acute or chronic infections within the past 60 days.
• Have current drug or alcohol abuse or dependence.
• Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.

Participants of the BLISS-76 and BLISS-52 Phase 3 clinical trials. Refer to ClinicalTrials.gov records NCT00410384 and NCT00424476 for further information about these studies.

This study is a secondary analysis of two existing clinical trial datasets. Anyone who wants to use the data should contact the primary study sponsor (GSK) via their data sharing website: https://clinicalstudydatarequest.com/