Belimumab (Benlysta®): The First FDA-Approved Biologic Agent for Lupus

HSS is proud to welcome the first biologic agent for lupus.
On March 9, 2011, the U.S. Food and Drug Administration (FDA) approved the use of Benlysta® (belimumab), developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK), in systemic lupus erythematosus patients with active disease despite standard treatment. This decision followed FDA’s Arthritis Advisory Committee’s 13-2 vote on November 16, 2010 to recommend the drug’s approval.

Among the many lupus drug trials that HSS has participated in over the years, Benlysta® is the first lupus medication that is approved by the FDA. Belimumab was specifically developed to target and block a newly discovered protein, B Lymphocyte Stimulator (BLyS), which promotes autoimmunity by permitting autoimmune B cells to live longer. Importantly, BLyS has been found at increased levels in the blood of patients with lupus and other autoimmune diseases.

[Learn more about some of the previous Benylsta® clinical trials.]

Hospital for Special Surgery rheumatologists Doruk Erkan, MD and Michael Lockshin, MD were co-investigators in one of the previous Benlysta® clinical trials. “There is a group of lupus patients not responding to traditional immunosuppressive agents for whom belimumab will be an important new alternative,” says Dr. Erkan, who is the Clinical Co-Director of the Mary Kirkland Center for Lupus Care at HSS. “However,” he continues, “patients should understand that belimumab is not effective for every lupus-related clinical problem, and it is not indicated for mild to moderate disease activity, which can be easily controlled with current medications.”

Dr. Lockshin, the Director of the Barbara Volcker Center for Women and Rheumatic Diseases at HSS, adds that "the most exciting thing is that the success of both aspects of this approach – using targeted biologics and assessing response to treatment in new ways – will encourage more trials and more opportunities for treating lupus patients in the future.”

Benlysta® is approved for autoantibody positive adult lupus patients (with active disease) as an intravenous administration of 10 mg/kg every two weeks for three doses, followed by the same dose every four weeks. However, the drug is not approved for those patients with active nephritis (kidney involvement) or severe active central nervous system disease due to lupus. Benlysta® has not been studied in combination with cyclophosphamide or other biologic agents. There are warnings regarding higher mortality reported in the controlled trials, possibility of serious infection, allergic reaction (including anaphylaxis), depression, and avoidance of live vaccines with this therapy.

The magnitude of benefit due to Benlysta® appears to be moderate (10% better than placebo for primary outcome), perhaps more evident after the first few months of therapy, and appears to enable tapering of glucocorticoids with no alarming toxicity.

Kyriakos Kirou, MD, FACR, the Clinical Co-Director of Mary Kirkland Center for Lupus Care at HSS, reported that “Benlysta® is expected to be used in patients whose disease activity despite standard care is not well controlled or does not allow reduction of prednisone to low levels. Patients that cannot tolerate standard therapy with other immunosuppressive agents such as mycophenolate mofetil, azathioprine, and methotrexate may also benefit from this agent.”

About The Mary Kirkland Center for Lupus Care

The Mary Kirkland Center for Lupus Care at Hospital for Special Surgery facilitates patient care and research with the ultimate goal of a better quality of life for Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome patients. More information about the Center can be obtained by calling the Center Manager, Pretima Persad, MPH, at 1-877-SLE-CURE (753-2873).


Headshot of Doruk Erkan, MD, MPH
Doruk Erkan, MD, MPH
Associate Attending Rheumatologist, Hospital for Special Surgery
Associate Professor of Medicine, Weill Cornell Medical College
Headshot of Kyriakos A. Kirou, MD, DSc, FACP
Kyriakos A. Kirou, MD, DSc, FACP
Director, Lupus Nephritis Program, Hospital for Special Surgery
Clinical Co-Director, Mary Kirkland Center for Lupus Care, Hospital for Special Surgery
Headshot of Michael D. Lockshin, MD
Michael D. Lockshin, MD
Attending Rheumatologist, Hospital for Special Surgery
Director, Barbara Volcker Center for Women and Rheumatic Disease

Related articles


In-person and virtual
physician appointments

Urgent Ortho Care

Same-day in-person or virtual appointments

Related Content

Departments and Services