Benlysta is a human monoclonal antibody that was approved for the treatment of lupus in adults by the U.S. Food and Drug Administration (FDA) in 2011 and for lupus nephritis in adults in 2020. Benlysta was approved to treat lupus in children in 2019 and lupus nephritis in children in 2022. A monoclonal antibody is a type of protein made in the laboratory that is developed to find and attach to only one type of substance in the body.

Benlysta is a human monoclonal antibody that specifically recognizes and blocks the biological activity of B-lymphocyte stimulator, or BLyS® (pronounced bliss), a naturally occurring protein which was discovered by scientists at Human Genome Sciences (HGS). Elevated levels of BLyS prolong the survival of B cells which can contribute to the production of autoantibodies – antibodies that target the body’s own tissues. Studies have shown that Benlysta can reduce autoantibody levels and help control autoimmune disease activity.

Benlysta was co-developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK). HGS has since been purchased by GSK. See our Benlysta® Development Fact Sheet for more information.

Benlysta represents a breakthrough in the treatment of lupus. Benlysta is the first drug approved to treat lupus in more than 50 years AND is the first drug developed specifically for lupus since the disease was identified more than a century ago! Successful treatment of lupus will require an arsenal of safe, effective, and tolerable treatments. The approval of Benlysta (approved March 2011) was a significant first step toward reaching that goal.

In 2020, Benlysta, in combination with standard therapy (with mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) was  approved by the FDA as a therapy for adult patients with active lupus nephritis. This is the first drug which has been approved by the FDA to treat lupus nephritis. 

Benlysta was approved to treat lupus in children in 2019 and to treat lupus nephritis in children in 2022.

Benlysta is the FIRST FDA-approved medication specifically designed for the treatment of lupus. Benlysta targets specific immune cells, rather than the blanket approach of other therapies which suppress the entire immune system. Currently approved medications for lupus are borrowed from other diseases and conditions; other treatments are used off-label, which means they were never approved by the FDA for lupus. Many of these treatments have serious and devastating side effects.

These drugs include high doses of steroids, antimalarial medications, immunosuppressive drugs, and organ-rejection drugs.

Benlysta Gateway is a centralized resource for patients and health care providers for one-on-one services and support. For more information call 1-877-4-Benlysta, Monday through Friday, 8AM to 8PM (EST). You can also visit www.benlysta.com for more information.

Each person with lupus is unique, and Benlysta may not be an option for everyone. You will need to discuss with your doctor whether Benlysta may be an appropriate treatment option for you.

Benlysta is approved for the treatment of adults and children five years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. Benlysta is also approved for the treatment of adults and children with active lupus nephritis who are receiving standard therapy.

Whether or not Benlysta can be effective for people with severe active central nervous system lupus or whether it will work when used with other biologics (a type of drug that suppresses the immune system) has not been studied. Benlysta should not be used in these situations.
 

Yes. On April 26, 2019 the U.S. Food and Drug Administration approved the use of Benlysta in children as young as five years of age. 

Benlysta was approved to treat lupus nephritis in children on July 27, 2022.

Yes, there are ongoing trials studying the outcomes and safety of Benlysta in many different people. Learn more about engaging in lupus research. 

Benlysta has been approved for adults and children who have active lupus nephritis.  Benlysta is not currently approved for those who have central nervous system involvement.

Benlysta was generally well-tolerated. The most commonly reported adverse reactions with Benlysta were nausea, diarrhea, fever, inflammation of the nose and throat, bronchitis, insomnia, pain in extremity, depression, and migraine.

In adults and children five years and up Benlysta can be  administered by a medical professional through an IV (intravenous) infusion directly into the vein; adults can self-administer an injection under the skin as well.  Benlysta now can be administered by IV infusion or as an under-the-skin injection for adults who have active lupus nephritis.  

Overall, vaccinations are considered to be safe and effective for people with lupus. However, it is not recommended for people with lupus to receive vaccines with a form of attenuated (weakened, but still live) virus and should not be exposed to recent recipients of live-vaccines such as oral polio virus (OPV). It is recommended that individuals always speak with their physician prior to receiving a vaccine.

The cost of Benlysta is in line with similar therapies. It is important for insurance companies to cover Benlysta since it is the first and only treatment developed specifically for lupus. 

The Lupus Foundation of America works to ensure that insurance companies cover treatment with Benlysta. 

Yes, GSK offers a co-pay and a Patient Assistance Program (PAP).  For more information visit www.benlysta.com/benefits-and-savings or call Benlysta Gateway 1-877-4-Benlysta (1-877-423-6597). 

There are a number of pioneering biotechnology and pharmaceutical companies involved in the research and development of new therapies for lupus and lupus nephritis. Several promising treatments are now in various stages of development with some in the near-term pipeline. We can’t make new treatments a reality without your support. You can help by learning more about clinical trials and volunteering to participate in a clinical trial.

Lupus is a complex disease. It can affect multiple organ systems and symptoms can range in severity from one day to the next. Also, lupus affects each person differently, with varying responses to treatment. The complexity and multiple ways lupus can affect the body presents challenges in evaluating potential new therapies. With each research study, regardless of the outcome, there are new discoveries that help pave the way for new therapies.

The Lupus Foundation of America has ongoing initiatives to standardize and improve clinical trial design, allowing future studies to be completed successfully. Additionally we actively work to inform people with lupus about clinical trial opportunities and engage people with lupus in ongoing research.  An example of our engagement initiatives is RAY, Research Accelerated by You, a lupus data platform where people with lupus and caregivers share information about their lupus experience to help researchers accelerate the development of new treatments and improve disease outcomes.  The Foundation also convened an international group of lupus experts to help identify the barriers and solutions to the most difficult problems people with lupus face. These initiatives, along with the recent approval of treatments for lupus nephritis, will help provide a pathway toward approval of additional treatments specifically developed for lupus.