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BENLYSTA for Lupus

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What Kind of Medicine is BENLYSTA?

BENLYSTA (belimumab) is a biologic therapy, not a steroid. It is taken in addition to your other lupus medications and is available in three options for adults with lupus and lupus nephritis:

  • an autoinjector you self-inject
  • a prefilled syringe you self-inject
  • an intravenous (IV) infusion a healthcare provider administers

For children ages 5 and above with lupus, BENLYSTA is available as an IV infusion.

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What’s Different About BENLYSTA?

Unlike other medicines used to treat lupus, BENLYSTA was specifically designed for lupus. In fact, it is the first and only approved treatment designed for lupus.

BENLYSTA is the first and only FDA-approved treatment for both lupus and lupus nephritis.

In many people with lupus, certain white blood cells called autoreactive B cells (cells that react against the body) stay in the body longer than they should. One of the important proteins for the growth of these B cells is called B-lymphocyte stimulator, or BLyS. BENLYSTA works by binding to BLyS. When BENLYSTA is attached to BLyS, BLyS can no longer bind to and stimulate the autoreactive B cells.

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Why BENLYSTA?

Whether you have active lupus or lupus nephritis, adding BENLYSTA to your treatment plan may help.

Adult Patients
In three clinical studies of adult patients with active lupus, BENLYSTA*:

  • Significantly reduced lupus disease activity mainly due to improvements in the immune system, muscles, mouth, joints, and skin
  • Significantly reduced risk of severe flares in two of the three studies†
  • Reduced steroid dose by 25% or more (to a daily dose of 7.5 mg or less) during Weeks 40-52, in patients receiving 7.5 mg or higher daily doses of steroid at the start of the study†‡

* These studies were used in the FDA approval of BENLYSTA.
† Compared to other lupus medicines alone.
‡ A reduction of steroid dose was seen but was not statistically significant.

Results may vary.
 

Ask your doctor if BENLYSTA is right for you.

Pediatric Patients (5 years and above)
When added to other medicines commonly used to treat lupus, compared to those medicines alone, BENLYSTA IV has been observed to§:

  • Reduce lupus disease activity§
  • Reduce the chance of severe flares§

§Because lupus doesn’t occur in children very often, the pediatric study had a much smaller number of patients than the adult studies of BENLYSTA. The study in children was still able to support that BENLYSTA worked, with results similar to those from the adult studies. Due to the small size of the study, however, there was no way to confirm the effect or the consistency of the results.

Please note that these are findings based upon a study in pediatric patients.
Your child’s individual results may vary.

HOW TO TAKE BENLYSTA

 

HOW TO TAKE BENLYSTA

BENLYSTA was studied in multiple clinical trials

BENLYSTA was studied in the largest successfully completed series of adult lupus clinical trials. BENLYSTA was also studied in the largest and longest lupus nephritis clinical trial ever conducted.

 

Study

Characteristics

BLISS-SC

Evaluated the efficacy, safety, and tolerability of BENLYSTA subcutaneous (SC) + other lupus medicines compared to other lupus medicines alone in adult patients with active SLE.

Duration: 52 weeks.

BLISS-52

Evaluated the efficacy, safety, and tolerability of BENLYSTA intravenous (IV) infusion + other lupus medicines compared to other lupus medicines alone in adult patients with active SLE.

Duration: 52 weeks.

BLISS-76

Evaluated the efficacy, safety, and tolerability of BENLYSTA intravenous (IV) infusion + other lupus medicines compared to other lupus medicines alone in adult patients with active SLE.

Duration: 76 weeks.

BLISS-LN

Evaluated the efficacy, safety, and tolerability of BENLYSTA intravenous (IV) infusion + other lupus medicines compared to other lupus medicines alone in adult patients with active, biopsy-proven LN.

Duration: 104 weeks.

The adult trials BLISS-SC, BLISS-52, and BLISS-76 showed that people treated with a combination of BENLYSTA and other lupus medicines experienced a superior reduction in disease activity at Week 52 compared to people who received the other lupus medicines alone.

The adult trial BLISS-LN showed that people treated with a combination of BENLYSTA and other lupus medicines experienced a reduction in kidney disease activity at Week 104 as measured by maintaining kidney function, reducing protein in the urine, and reducing the need for rescue medicines|| compared to people who received the other lupus medicines alone.

||Rescue medicines such as steroids >10 mg/day.

Learn about BENLYSTA for lupus nephritis

Additionally, BENLYSTA was studied in children and adolescents with SLE.

Study

Characteristics

PLUTO

Evaluated the efficacy, safety, and pharmacokinetics of BENLYSTA intravenous infusion (IV) + other lupus medicines compared to other lupus medicines alone in children and adolescents (5-17 years) with active SLE.

Are you ready to learn more about BENLYSTA?

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How BENLYSTA Works

Watch this short video to learn more about what lupus is, how it affects the body, and how BENLYSTA works.

TRANSCRIPT

Narrator: The human immune system is made up of organs and lymphatic vessels and nodes. It also consists of cells and a wide range of chemical messengers and other proteins that are produced by these cells of the immune system. This is the system that helps protect us from infections caused by bacteria, viruses, and other germs. B cells, a type of white blood cell, are an important component of the immune system. These cells recognize and fight germs by producing a special type of protein called an antibody. Antibodies recognize and latch onto germs. This attachment is a key step in how the immune system protects from infection and fights infection. Working together, the many parts of the immune system play a vital role in maintaining health.

When the immune system is not working properly, however, it can cause illness rather than help maintain health. Systemic lupus erythematosus, or SLE, is one of many diseases caused by abnormal immune system activity. In many people with lupus, certain B cells remain in the body longer than they should. These cells, called autoreactive B cells, play a role in causing lupus. Like other B cells, autoreactive B cells can produce antibodies. But the antibodies released by autoreactive B cells do not fight germs. Instead, these antibodies, which are called autoantibodies, attach to normal tissues inside the body. When this happens, the autoantibodies end up attacking your own body and tissues can become inflamed.

All of the cells of the immune system are influenced by chemical messengers. For example, one of the chemical messengers that binds to and helps the growth of B cells – including autoreactive B cells – is called BLyS. BLyS is short for B-lymphocyte stimulator. BENLYSTA works by binding to BLyS. When BENLYSTA is attached to BLyS, BLyS can no longer bind to and stimulate the autoreactive B cells. Adding BENLYSTA to your other lupus treatments may help reduce the abnormal immune system activity that contributes to disease activity in lupus.

Frequently Asked Questions

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  • Do I need to take BENLYSTA with other lupus medicines?

    Yes. BENLYSTA is used to treat children ages 5 and above and adults with active SLE who are receiving other lupus medicines. Intravenous dosing of BENLYSTA is approved for patients 5 years and older, and subcutaneous dosing is only approved for adults. It is not known if BENLYSTA is safe and effective in people with severe active central nervous system lupus.

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  • How is BENLYSTA administered to patients with lupus?

    BENLYSTA is either given by intravenous (IV) infusion (for children ages 5 and above and adults) every 2 weeks for the first three doses and then every 4 weeks thereafter, or injected subcutaneously (SC) (for adults only) once a week, either with an autoinjector or a prefilled syringe.

    It is not available in pill form. 

    Learn more about dosing for BENLYSTA.

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  • How many patients were included in the clinical trials with BENLYSTA?

    BENLYSTA has the largest lupus clinical trial program to date.  BENLYSTA has been studied in multiple lupus clinical trials involving more than 2,500 adult patients, over 1,100 of whom were treated with BENLYSTA. To date, the pediatric program has included 93 children with lupus. BENLYSTA was also studied in the largest and longest lupus nephritis clinical trial ever conducted, which involved 448 adult patients.

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  • What are the most common side effects of BENLYSTA?

    The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, persistent cough, trouble sleeping, leg or arm pain, depression, headache, pain, redness, itching, or swelling at the site of injection (when given subcutaneously).

     

    These are not all the possible side effects of BENLYSTA. Talk to your healthcare provider for medical advice about side effects.

     

    Risks and side effects

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  • Can taking BENLYSTA make it easier for me to get an infection?

    Immunosuppressive agents, including BENLYSTA can cause serious side effects. Infections could be serious, leading to hospitalization or death. Symptoms of an infection can include fever, urinating often, chills, coughing up mucus, pain or burning with urination, and warm, red, or painful skin or sores on your body. Tell your healthcare provider right away if you have any of the symptoms listed above while receiving BENLYSTA.

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Looking for a physician?

If you are looking to find a lupus physician to help you or a loved one take the next step with BENLYSTA, we are here to help.

FIND A PHYSICIAN NEAR YOU

Looking for coverage assistance?

When you start BENLYSTA treatment, you also have access to help understanding your health insurance coverage with BENLYSTA Gateway & Co-pay Program. LEARN ABOUT YOUR COVERAGE OPTIONS