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Belimumab Is Approved by the FDA: What More Do We Need to Know to Optimize Decision Making?

  • SYSTEMIC LUPUS ERYTHEMATOSUS (JT MERRILL, SECTION EDITOR)
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Abstract

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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References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Disclosure

Dr. Horowitz has received research support from Human Genome Sciences.

Dr. Furie has served as a consultant for, served on advisory boards for, received honoraria from, received payment for development of educational presentations (including service on speakers’ bureaus) from, and had travel/accommodations expenses covered/reimbursed by Human Genome Sciences and GlaxoSmithKline. He has also received research support from Human Genome Sciences.

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Authors and Affiliations

  1. Division of Rheumatology and Allergy-Clinical Immunology, Hofstra North Shore-LIJ School of Medicine, Manhasset, NY, USA

    Diane Lewis Horowitz & Richard Furie

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  1. Diane Lewis Horowitz
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  2. Richard Furie
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Correspondence to Diane Lewis Horowitz.

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Horowitz, D.L., Furie, R. Belimumab Is Approved by the FDA: What More Do We Need to Know to Optimize Decision Making?. Curr Rheumatol Rep 14, 318–323 (2012). https://doi.org/10.1007/s11926-012-0256-4

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  • DOI: https://doi.org/10.1007/s11926-012-0256-4

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