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Proposal 1421

Title of the 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

GSK-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

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.