Examine the efficacy and safety of Belimumab in treatment of newly diagnosed Systemic Lupus Erythematosus in Chinese population

Examine the efficacy and safety of Belimumab in treatment of newly diagnosed Systemic Lupus Erythematosus in Chinese population

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with multi-organ involvements and heterogeneous clinical manifestations, characterized by B cell hyperactivity and pathogenic autoantibodies formation. The loss of B cell tolerance and overactivation of T cells which result in excess production of autoantibodies are thought to be central in the role of pathogenesis of SLE. It is well accepted in the field that SLE disease duration is an important factor when predicting the responses to treatments. Based on our clinic experience, we discovered that patients with early disease responded better to Belimumab compared to those with longer disease duration. This discovery is consistent with a recent study from Italy indicating that early disease and low baseline organ damage were predictors of SRI-4 response. However, this discovery was observational based has not been well controlled and compared to standard of care (SOC). As mentioned in guidelines from different regions, early proper treatment has been promoted as a critical target in SLE management partially because it has been well known that early low disease activity or remission was associated with better prognosis. It is important to point out that the average disease duration of patients enrolled in the RCT studies was relatively long and none of them was stratified to examine the influence of disease duration on Belimumab efficacy and safety. Therefore, it is critical to conduct a study to examine and compare Belimumab to standard of care in SLE patients with early disease. However, the efficacy and safety of Belimumab has not been evaluated in Chinese SLE patients with short disease duration. This study aims to extract Chinese SLE patients with short disease duration and examine their response to the treatment of Belimumab. We hypothesize that SLE patients with early disease respond better to Belimumab plus SOC than SOC alone in achieving disease control.

[{ "PostingID": 19766, "Title": "GSK-BEL113750", "Description": "GSK1550188 A 52 week study of belimumab versus placebo in the treatment of subjects with systemic lupus erythematosus (SLE) located in Northeast Asia" }]