Examination of new systemic lupus erythematosus (SLE) activity index development

Examination of new systemic lupus erythematosus (SLE) activity index development

Systemic lupus erythematosus (SLE) is an autoimmune disease that mistakenly attacks healthy tissue and can affect the skin, joints, kidneys, brain and other organs. In the clinical trials of SLE, composite measures including SLE Disease Activity index (SLEDAI), SLE Responder Index 4 (SRI4), British Isles Lupus Assessment Group (BILAG) and BILAG-based Combined Lupus Assessment (BICLA) have often been used as an endpoint of clinical trials. However, none of these measures can be used as a gold standard because one was good for a trial but failed in another. When assessing the efficacy of treatment, physicians usually focus on the improvement of markers derived from the serum from blood tests, but many of the measures including SLEDAI and SRI adopt binary variables and some of the outcomes including BILAG even do not include the serological variables. When assessing the severity of an SLE patient, physicians usually focus on the most severely affected organ(s), and summing severity scores of all affected organs may not reflect the real severity of the patient. Physicians also stress whether doses of glucocorticoids that is the most important anti-inflammatory drug for treatment of SLE were able to be reduced to the clinically meaningful low level.The objective of our research is to establish a new SLE treatment response index to enable more accurate evaluation of drug efficacy. We are planning to make a novel measurement outcome to discriminate belimumab group from placebo group in the BLISS-52 trials and BLISS-76 trials and verify it in the BLISS-NEA trials by focusing on evaluation of the most severe organ in BILAG and also including markers derived from the serum from blood tests quantitatively.We create different new quantitative indices combining BILAG, complement and anti-DNA antibody, then we search for the most appropriate index that can most effectively differentiate the placebo group and the belimumab group using BLISS-52 and BLISS-76 data, and verify with BLISS-NEA data. We search for the best BILAG score combination to discriminate the belimumab group from placebo group. Anti-DNA antibodies and complements would be incorporated into a new index. We compare index considering only patients with abnormal values and considering all patients. We will assess the degree of improvement of these comparative values in percentage terms.

[{ "PostingID": 1416, "Title": "GSK-HGS1006-C1056", "Description": "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)" },{ "PostingID": 1417, "Title": "GSK-HGS1006-C1057", "Description": "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)" },{ "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" },{ "PostingID": 20307, "Title": "GSK-BEL114333", "Description": "BEL114333, a Multicenter, Continuation Study of Belimumab in subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase III study BEL113750 in Northeast Asia or completed the open-label extension of HGS1006-C1115 in Japan" }]