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Belimumab, a B cell modulator that inhibits soluble BlyS, was the first agent approved by the FDA for systemic lupus erythematosus (SLE) in over 50 years. Although its licensed indication is broad, only 5 % of lupus patients in the USA have been prescribed the agent since its introduction in 2011. This is largely a consequence of uncertainties relating to length/duration of treatment; long-term safety especially concerning mental health issues; response in patients with nephritis, central nervous system disease, and pediatric lupus; efficacy among African-Americans; and perceived lack of pharmacoeconomic benefits. Over 95 % of post-approval-treated patients reside in the USA. Nonetheless, belimumab has turned out not only to be remarkably safe and well tolerated but is also associated with clear cut clinical improvement in approximately 70 % of individuals who have been treated. Its principal benefits are observed in patients with moderate to severe disease with mucocutaneous, musculoskeletal, constitutional, and/or serositis manifestations who are not responsive or unable to decrease their corticosteroid dose, as well as those who are intolerant to or in whom methotrexate, mycophenolate mofetil, or azathioprine are not effective or contraindicated. Work on its use as induction therapy for recent onset lupus is a promising avenue for investigation.

Belimumab: Where Are We Three Years After FDA Approval?