belimumab (Benlysta)
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Epidemiology
- may not be effective in people of African descent
Indications
- treatment of patients with systemic lupus erythematosus already on standard treatment[1]
- lupus nephritis
Contraindications
Dosage
- 10 mg/kg given as an IV infusion on study days 0, 14, & 28 then every 4 weeks thereafter for a total of 48 weeks[2]
Monitor
- CBC, basic metabolic panel, LFTs, serum IgG at baseline, at 2 weeks, & every 3 months thereafter[3]
Adverse effects
- risk of infection
- increased mortality
- drug adverse effects of immunosuppressive agents
- drug adverse effects of biologic immunosuppressive agents
- drug adverse effects of pharmaceutical monoclonal antibodies
Mechanism of action
- human monoclonal antibody that targets the B-lymphocyte stimulator protein (TNFSF13B, BLyS, BAFF)
Management
- whenever possible bring patients up to date on vaccinations prior to initiating biologic immunosuppressive agent[3]
Notes
- costs at least $35,000 per year (2011)[2]
- self-injectable belimumab (Benlysta) for SLE FDA-approved July 2017
More general terms
References
- ↑ 1.0 1.1 FDA NEWS RELEASE: March 9, 2011 FDA approves Benlysta to treat lupus http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246489.htm
- ↑ 2.0 2.1 2.2 Prescriber's Letter 18(5): 2011 Management of Systemic Lupus Erythematosus Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270512&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 3.0 3.1 3.2 3.3 Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18, 19. American College of Physicians, Philadelphia 2012, 2015, 2018, 2022.
- ↑ 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 Dec;63(12):3918-30 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22127708
- ↑ Brooks M FDA Clears Self-injectable Belimumab (Benlysta) for SLE Medscape - Jul 21, 2017. http://www.medscape.com/viewarticle/883270
- ↑ Garcia A, De Sanctis JB. A Review of Clinical Trials of Belimumab in the Management of Systemic Lupus Erythematosus. Curr Pharm Des. 2016;22(41):6306-6312. Review. PMID: https://www.ncbi.nlm.nih.gov/pubmed/27587201