Last updated: November 24, 2014
Trade Name: Benlysta
Drug Class: B-lymphocyte stimulator (BlyS)-specific inhibitor
Preparations: 120 mg/vial, 400 mg/vial
Dose: 10 mg/kg as an IV infusion over 1 hour every 2 weeks for first 3 doses and every 4 weeks thereafter. Premedication to reduce infusion reactions is usual.
Indications: Active antibody positive SLE
Mechanism of Action: A human IgG1 monoclonal antibody that blocks binding of soluble BlyS to its receptors on B-cells. Inhibits B-cell survival and differentiation.
Contraindications: Hypersensitivity, active infection
Precautions: In clinical trials increased mortality and depression. Risk of serious infections. Avoid live virus vaccines. Combination with other biologics or cyclophosphamide not recommended.
Monitoring: Monitor clinically for infection and depression
Pregnancy Risk: C
Common: Mild infusion reactions, nausea, diarrhea, nasopharyngitis
Less common: Depression, infection
Rare: Anaphylaxis, progressive multifocal leucencephalopathy
Drug Interactions: Concurrent use of immunosuppressants may increase risk of infection.
Patient Instructions: Avoid live virus vaccines, avoid pregnancy, call your doctor if an infection or fever develops that lasts more than a few days.
Comments: In clinical trials modestly effective, primarily for skin and musculoskeletal manifestations at 52 weeks but not at 76 weeks. Not evaluated in severe active lupus nephritis or central nervous system and not recommended. Unclear if African-Americans respond as well.
Clinical Pharmacology: Half-life is 19 days. Biologic agents are not metabolized and thus have few drug interactions.
Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum 2011;63:3918-30. PMID: 22127708.