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Cost utility analysis comparing belimumab against rituximab in systemic lupus erythematosus
Proposal
1421
Title of Proposed Research
Cost utility analysis comparing belimumab against rituximab in systemic lupus erythematosus
Lead Researcher
Chris Gillette
Affiliation
Wingate University
Funding Source
None
Potential Conflicts of Interest
None
Data Sharing Agreement Date
13 July 2016
Lay Summary
Systemic lupus erythematosus (SLE) is a multi-organ autoimmune disease. SLE typically affects women of childbearing age. Additionally, SLE affects Black and Asian Americans more often than other races. There is no cure for SLE and the goal of treatment is to control symptoms. The most common medications to treat SLE are non-steroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs. A new medication, belimumab (Benlysta), has recently been approved by the FDA for adult patients with active, autoantibody-positive SLE. Rituximab may be used for SLE patients off-label for those with active disease. However, treatment with rituximab may result in more side effects and less efficacy. This research will study if belimumab is more cost effective in treating SLE when compared with rituximab. This study will also convert the SF-36 health-related quality of life measure that patients completed during two Phase 3 RCTs in belimumab into utilities that will be used to compare belimumab with rituximab.
Study Data Provided
[{ "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)
Medicine: belimumab, Condition: Systemic Lupus Erythematosus, Phase: 3, Clinical Study ID: HGS1006-C1057, Sponsor: GSK" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
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