Journal
CURRENT RHEUMATOLOGY REPORTS
Volume 14, Issue 4, Pages 318-323Publisher
SPRINGER
DOI: 10.1007/s11926-012-0256-4
Keywords
Systemic lupus erythematosus; SLE; Belimumab; Lupus; Biologic treatment; FDA; Approval; Response; Discontinue
Categories
Funding
- Human Genome Sciences
- GlaxoSmithKline
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The March 2011 approval of belimumab (Benlysta) by the US Food and Drug Administration has left rheumatologists in a bit of a quandary regarding its use. It is officially intended for adult patients with autoantibody-positive systemic lupus erythematosus whose disease remains active despite receipt of standard-of-care therapy. The approved indication is broad and leaves interpretation to individual rheumatologists. Analyses of the phase 2 and 3 clinical trials of belimumab help answer some of the commonly asked questions, such as the following: 1) Who is the appropriate patient for belimumab? 2) How does one measure response? 3) When should results be expected in a patient newly treated with belimumab? 4) When should belimumab be discontinued?
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