Mohammed AlrjoubInstructor : Dr.Adham Abu Taha

Benlysta(belimumab)

Date of Approval: March 10, 2011

Treatment for: Systemic Lupus Erythematosus

Company: Human Genome Sciences, Inc. and GlaxoSmithKline

what is Systemic Lupus Erythematosus

• is a systemic autoimmune disease (or autoimmune connective tissue disease) that can affect any part of the body. As occurs in other autoimmune diseases, the immune system attacks the body's cells and tissue, resulting in inflammation and tissue damage. It is a Type III hypersensitivity reaction caused by antibody-immune complex formation. SLE most often harms the heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous system..

MOA:Belimumab is a human IgG1gamma monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BLyS), a B cell survivor factor. It blocks the binding of soluble BLyS to its receptors on B cells, thus inhibiting the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma

DOSING: The recommended dose of belimumab is 10 mg/kg at two-week intervals for the first three doses and at four-week intervals thereafter. Belimumab is administered intravenously over a one-hour period

• Benlysta: is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells that the problem in lupus.

What's new about this drug?

Adverse Reaction(s):Infections (eg, URI, UTI, nasopharyngitis, sinusitis, bronchitis, influenza; may be serious/fatal), psychological effects (eg, depression, insomnia, anxiety, suicide), GI upset, fever, migraine, extremity pain, infusion and/or hypersensitivity reactions.NURSING MOTHERS and pregnants should not take benlysta

DRUG INTERACTIONS: Drug interactions have not been studied. Since belimumab reduces the activity of the immune system it may interfere with the response to immunizations. Live vaccines should not be administered concurrently with belimumab or at least 30 days before administration of belimumab.

• See “What is the most important information I should know about BENLYSTA?”

• 1. Cancer. BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.

• 2. Allergic (hypersensitivity) and infusion reactions. Serious allergic or infusion reactions can happen on the day of or the day after receiving BENLYSTA.

• In my view, Benlysta’s benefits appear to be marginal and even questionable for patients.

• the approval of Benlysta may encourage other companies to move forward with drugs for lupus, because it is the first new

lupus drug to come to market in more than 50 years,. In that way, perhaps, the medication may have more significant benefits for patients.

References

• www.fda.gov• www.emp.com• www.drugs.com• www.medicinenet.com• www.makpive.us