Belimumab: A Review in Systemic Lupus Erythematosus

Belimumab (Benlysta ® ) is a human immunoglobulin G1λ monoclonal antibody that inhibits the binding of soluble B lymphocyte stimulator to B cells. It is the only biological agent currently approved for the treatment of non-renal systemic lupus erythematosus (SLE). Belimumab is approved in the EU, th...

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Bibliographic Details
Published in:Drugs (New York, N.Y.) N.Y.), 2018-03, Vol.78 (3), p.355-366
Main Authors: Blair, Hannah A., Duggan, Sean T.
Format: Article
Language:English
Subjects:
Adis Drug Evaluation
Antibodies, Monoclonal, Humanized - administration & dosage
Antibodies, Monoclonal, Humanized - adverse effects
Antibodies, Monoclonal, Humanized - therapeutic use
Arthritis
Autoantibodies
Autoimmune diseases
B-Cell Activating Factor - antagonists & inhibitors
B-Cell Activating Factor - metabolism
B-Lymphocytes - metabolism
Biomarkers
BLyS protein
Chronic conditions
Clinical trials
Cost analysis
Disease control
Dose-Response Relationship, Drug
Drug dosages
Fatigue
Humans
Immunogenicity
Immunoglobulin G - immunology
Immunoglobulin lambda-Chains - immunology
Immunoglobulins
Immunosuppressive agents
Internal Medicine
Lupus
Lupus Erythematosus, Systemic - drug therapy
Lymphocytes B
Medical research
Medicine
Medicine & Public Health
Monoclonal antibodies
Patients
Pharmacology/Toxicology
Pharmacotherapy
Protein Binding
Quality of Life
Rheumatology
Stimulators
Systemic lupus erythematosus
Therapy
Treatment Outcome
Tumor necrosis factor-TNF
Vaccines
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Description
Summary:Belimumab (Benlysta ® ) is a human immunoglobulin G1λ monoclonal antibody that inhibits the binding of soluble B lymphocyte stimulator to B cells. It is the only biological agent currently approved for the treatment of non-renal systemic lupus erythematosus (SLE). Belimumab is approved in the EU, the USA and other countries as add-on therapy in adult patients with active, autoantibody-positive SLE despite standard therapy. In phase III trials, treatment with IV or SC belimumab plus standard therapy was effective in terms of reducing overall disease activity and reducing the incidence and severity of flares, without worsening of patients’ overall condition or the development of significant disease activity in new organ systems. Sustained disease control was maintained during longer-term (up to 10 years) treatment with IV belimumab. Belimumab also demonstrated steroid-sparing effects and was associated with clinically meaningful improvements in health-related quality of life and fatigue. Belimumab was generally well tolerated in clinical trials, with low rates of immunogenicity. In view of the flexibility regarding the route of administration and the convenience of the once-weekly, self-administered, SC regimen, add-on therapy with belimumab is a useful treatment option for patients with active, autoantibody-positive SLE despite standard therapy.
ISSN:0012-6667
1179-1950
DOI:10.1007/s40265-018-0872-z